Literature DB >> 36201441

Application of the Theoretical Framework of Acceptability to assess a telephone-facilitated health coaching intervention for the prevention and management of type 2 diabetes.

Linda Timm1,2, Kristi Sidney Annerstedt2, Jhon Álvarez Ahlgren3, Pilvikki Absetz4, Helle Mølsted Alvesson2, Birger C Forsberg2, Meena Daivadanam2,5,6.   

Abstract

BACKGROUND: Lifestyle interventions focusing on diet and physical activity for the prevention and management of type 2 diabetes have been found effective. Acceptance of the intervention is crucial. The Theoretical Framework of Acceptability (TFA) developed by Sekhon et al. (2017) describes the multiple facets of acceptance: Affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. The aims of this study were to develop and assess the psychometric properties of a measurement scale for acceptance of a telephone-facilitated health coaching intervention, based on the TFA; and to determine the acceptability of the intervention among participants living with diabetes or having a high risk of diabetes in socioeconomically disadvantaged areas in Stockholm.
METHODS: This study was nested in the implementation trial SMART2D (Self-management approach and reciprocal learning for type 2 diabetes). The intervention consisted of nine telephone-facilitated health coaching sessions delivered individually over a 6-month period. The acceptability of the intervention was assessed using a questionnaire consisting of 19 Likert scale questions developed using Sekhon's TFA. Exploratory factor analysis (EFA) was performed.
RESULTS: Ratings from 49 participants (19 with type 2 diabetes and 30 at high risk of developing diabetes) in ages 38-65 were analyzed. The EFA on the acceptability scale revealed three factors with acceptable reliabilities: affective attitude (alpha 0.90), coherence and understanding (alpha 0.77), perceived burden (alpha 0.85), explaining 82% of the variance. Positive affect and coherence had high median scores and small variance. Median score for perceived burden was low, but with significant variance due to younger individuals and those at high risk reporting higher burden.
CONCLUSIONS: The telephone-facilitated health coaching intervention was perceived as acceptable by the study population using a questionnaire based on Sekhon's TFA, with a wider variation in perceived burden seen among high risk and younger participants.

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Year:  2022        PMID: 36201441      PMCID: PMC9536591          DOI: 10.1371/journal.pone.0275576

Source DB:  PubMed          Journal:  PLoS One        ISSN: 1932-6203            Impact factor:   3.752


Introduction

Lifestyle interventions focusing on diet, physical activity and(or) self-care behaviors for the prevention and management of type 2 diabetes (T2D) have been shown effective in improving cardio-metabolic outcomes [1, 2] in different population groups [2, 3]. Low participation rate and drop-outs are often a problem, suggesting issues related to accessibility and acceptance [4, 5]. This can be particularly challenging in groups with low socioeconomic status [6], where other social problems may require more attention [7]. Telephone coaching to support self-management is one strategy to overcome problems related to access [8-10]. Self-management of T2D leads to improvements in glycemic control [1]. Social support and education to manage the disease have been shown to improve self-management [11-13]. Improvements in health behavior, self-efficacy and health status among persons with chronic conditions (such as T2D, congestive cardiac failure, coronary artery disease, chronic obstructive pulmonary disease and hypertension) were reported in a systematic review on telephone-based interventions [8]. In this study, it was shown that telephone coaching was particularly beneficial to vulnerable populations, defined as individuals with low socioeconomic status, culturally and linguistically diverse backgrounds, low access to health services and often with worse control of their chronic conditions during baseline. Such interventions tend to have multiple components and are therefore complex, both in terms of their design and implementation. Successful implementation of complex health interventions depend on many factors including acceptance of the intervention, and acceptability is seen as key when designing feasibility studies [14]. Interventions experienced as less intrusive have been reported as more acceptable [15], and studies suggest this also to be case with telephone coaching [9, 15]. However, there are examples of in-person coaching reported as more comfortable than coaching over telephone [9]. Comfort is, however only one aspect of acceptability. Acceptability has been defined as “a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention” [16]. While acceptability has long been recognized as an important criterion for user acceptance [17-19], it has been relatively underinvestigated [19], and there is no consensus on how to evaluate it. Based on a review of systematic reviews, Sekhon et al. (2017) [16] developed the Theoretical Framework of Acceptability (TFA) with seven domains; affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. The TFA has since been used to evaluate a telephone support intervention with automated calls to improve self-management for persons with kidney disease [9]. The study used four of Sekhon’s seven domains [16] to report both their quantitative and qualitative findings, and deemed telephone coaching to be an acceptable intervention method [9]. Although Sekhon’s model on acceptability has been used to report the acceptability of interventions [9], the literature on quantitative assessments of acceptability using this model is scarce, and only a few quantitative tools have been developed based on the model. The aims of our study therefore were to: 1) develop and assess the psychometric properties of a measurement scale for acceptance of telephone-facilitated health coaching intervention, based on the TFA; and 2) determine the acceptability of the intervention among participants living with diabetes or having a high risk of developing diabetes in socioeconomically disadvantaged areas in Stockholm using the newly developed tool based on the TFA.

Material and methods

This study was nested in SMART2D (Self-management approach and reciprocal learning for type 2 diabetes) [ISRCTN 11913581], a 5-year project (2015–2019) on implementation of contextualized self-management support in Sweden, South Africa and Uganda [20]. This study was conducted as part of the feasibility trial implemented in the Swedish arm of the SMART2D. Approval for the SMART2D trial protocol was given by the Regional Ethical Review Board in Stockholm effective 20th February 2017 (2016/2521-31/1). Written informed consent was obtained from each participant prior to enrollment in the SMART2D feasibility trial and permission was sought prior to the acceptability study. The Template for Intervention Description and Replication (TIDieR) checklist has been used for reporting (S1 Appendix).

Setting

The study was implemented in two socioeconomically disadvantaged communities of Stockholm. These areas were characterized by low income levels and high unemployment rates. Compared to the overall Stockholm county, these areas have a high proportion of immigrants (Table 1).
Table 1

Study setting characteristics.

Study areaSite 1Site 2Stockholm county
Proportion of immigrants (persons born outside Sweden or native born with both parents born outside Sweden)88.3%61.1%33.3%
Unemployment rate 8%6.1%3%
Income level SEK/year 204,600245,600374,400

SEK: Swedish kronor.

SEK: Swedish kronor.

Participant recruitment

265 participants were recruited to participate in the SMART2D feasibility trial from two sources; 1) open community screening in public spaces at different time points and 2) out-patient lists from the primary healthcare centers. The participants had either a diagnosis of T2D within the last five years, or were identified as high risk of developing diabetes at the time of recruitment i.e., had a diagnosis of prediabetes or a score >13 on the Finnish Diabetes Risk Score (FINDRISC) [21, 22]. The feasibility trial used a cluster randomized design and 131 participants were included in the intervention arm. Of these, 72 participants (T2D: 29; high-risk: 43) received the telephone-facilitated health coaching intervention and the remaining were lost to follow-up.

Swedish SMART2D intervention

Development of the intervention as well as final intervention components have been described in detail elsewhere [4]. The intervention consisted of nine telephone-facilitated health coaching sessions (Table 2). The sessions were delivered individually by trained facilitators (SMART2D team members) on a weekly basis during the first five weeks and biweekly thereafter. The delivery period for the intervention was six months in total, from November 2018 to May 2019. During this period, the participants received structured support on lifestyle related habits over phone. An additional component of the intervention was to encourage social support through care companions (family members, friends or peers in the participant’s close social network), with the aim of setting up goals and engaging in health-related activities together. Except for the introductory and concluding sessions, the remaining sessions focused alternately on diet and physical activity (Table 2). The facilitators followed a structured topic guide for each session based on the Motivational Behavioral Coaching (MBC) approach [23]. The participants were encouraged to set goals towards small changes by building on healthy habits and activities they were already familiar with. The focus was on positive affective processes [24, 25] i.e., working towards a specific goal with positive emotions which makes it more likely for the new health behavior to be maintained [24]. The sessions always started with a follow-up about the previous session and included a discussion on their goals and the next steps for further improvement. Every session ended with a question about the content of the session.
Table 2

Overview of session structure in the telephone-facilitated health coaching intervention.

SessionTitleContent
1Introductory sessionGetting to know the program. Why work with a care companion to make lifestyle changes?
2Increase physical activity in daily life and reduce sedentary lifestyleThe importance of physical activity and how this can be increased in daily life
3Healthy eating: Regular, balanced and healthyThe importance of regular, balanced and healthy meals
4Physical activity through the life courseDiscussion on how physical activity levels have changed over the years
5Fruit and vegetablesThe importance of eating fruit & vegetables every day
6Increasing your daily physical activityDiscussion on current situation and potential possibilities for improvements
7SugarHow sugar consumption can be decreased in daily life
8Finding a physical activity that suits youDiscussion of options/choices to physical activity
9Healthy lifestyle—moving forwardHow has it been to try to change to a healthier lifestyle and how can this be maintained?
The sessions were delivered in Swedish, mostly using ‘easy Swedish’ with no use of medical or technical terms. When the participants’ Swedish language skills were too limited to receive the intervention in Swedish, the intervention was delivered in the participants’ native language by language skilled facilitators in Arabic, Somali or Spanish. Some participants preferred to have the intervention delivered in English, which was offered by all facilitators. The median duration per session was 19 minutes (range: 12–25 min) (Table 3).
Table 3

Duration per session.

SessionMedian duration (50%)Range (25%-75%)Observations
All sessions1912–25308
1119–1245
21915–2347
322.518–2744
41916–2533
52013.5–25.532
616.512–23.528
719.515–2326
81913–2724
92621–3529
In addition, two physical meetings per study site were arranged in the local community where the participants had the opportunity to meet each other, the facilitators, representatives from primary care, collaborating community organizations, experts or practitioners in diabetes, diet and physical activity, and other SMART2D team members. The meetings lasted approximately 3,5 hours each.

Acceptability tool

Questions were developed for each of the seven dimensions of Sekhon’s acceptability framework [16] in relation to the SMART2D intervention. The instrument aimed to assess the acceptability of the intervention through a total of 19 questions (Fig 1).
Fig 1

Questions related to the seven domains in Sekhon’s Theoretical Framework of Acceptability.

The questionnaire used a 5 point Likert scale, where responses ranged from 5 (strongly agree) to 1 (strongly disagree). The content validity of the scale was evaluated by four researchers in the areas of public health, complex behavior change interventions, implementation science and medical anthropology and subsequently piloted with four participants.

Data collection

At the end of the last telephone-facilitated health coaching session (session 9), the participants were asked for their consent to answer questions about the intervention later on during the same week. The acceptability survey was thereafter administered by a newly recruited research assistant with no prior knowledge about the project or contact with any of the participants. In addition participants who did not complete the intervention (< 3 sessions) were invited to fill in the acceptability survey. The survey took approximately ten minutes to complete. Out of the 72 participants who started the intervention, 54 participated in the acceptability survey. Five were excluded during the analysis due to incomplete responses. Data related to 49 participants, who had all completed the intervention, were included in the analyses for this study (response rate, 69%) (Fig 2).
Fig 2

Flow chart describing participant sampling for assessing acceptability of the SMART2D intervention.

Data analysis

Descriptive statistics were computed to explain variable distributions. The scores of negatively worded statements were reversed in order to align the direction of the scale. Criterion validity was determined through Spearman’s rank correlation coefficients, a non-parametric correlation test that is less susceptible to outliers, constructed between different items from the questionnaire. Exploratory factor analysis (EFA) was performed to assess the construct validity (discriminant and convergent validity) of the acceptability domains from the Sekhon framework [16]. Oblique (promax) rotations were selected to identify structure patterns and interpret the eigenvalues. The parallel analysis method was used to determine the number of factors to be retained. The Kaiser-Meyer-Olkin (KMO) measure of sampling adequacy was performed to confirm the appropriateness of data for the EFA [26] (KMO = 0.6230). Items with maximum loadings less than 0.40 were dropped. The internal consistency of the tool was assessed using Cronbach’s alpha. Scores between 0.7 and 0.9 were deemed appropriate [27]. Likert summated scales were calculated for each participant within the identified construct from the EFA. Since the scales had a different number of items per construct, the sum-scales were standardized to range from 0 to 100 [28]. Wilcoxon rank-sum test was conducted to detect differences between the sum-score for each domain and the socio-demographic characteristics. The statistical software package STATA version 15.1 was used to conduct the analysis.

Results

Characteristics of the study population in comparison with those who did not conduct the acceptability survey are shown in Table 4. The majority of respondents were at high risk of developing diabetes (62%) and the age was in general lower in the high-risk group compared to participants with diabetes. In general, we had more female participants in the trial including the intervention arm and this pattern held true for participants and non-participants of the acceptability trial. The majority of participants were born outside Sweden (67%). The unemployment rate was higher in the high-risk group, which was also shown in the lower monthly income level in this group. No significant differences were found in employment status and income level between the participant groups. Therefore, no further analysis on the factor score distribution in relation to these variables were conducted. The participants in the acceptability trial and those who did not participate differed significantly only in terms of the number of intervention contacts.
Table 4

Participant characteristics.

Diabetes n (%)High-risk/ prediabetes or diabetesTotal from the Acceptability studyParticipants who did not conduct the Acceptability surveyp-values
n = 19n = 30n = 49n = 23
19 (38)30 (62)
Sex
Female10 (53)25 (83)35 (71)14 (61)0.370^
Male9 (47)5 (17)14 (29)9 (39)
Age * 58 (48–65)44 (38–57)49 (40–60)53 (46–64)0.129
Younger46 (40–49)39 (36–43)41(36–44)45 (41–46)0.231
Older64 (58–69)59 (57–69)60 (57–69)60 (53–66)0.834
Household monthly Income (SEK) * 32,500 (22,000–44,800)20,000 (10,000–35,000)**29,500 (16,000–41,500)***25,000 (13,000–45,000)0.7334
Employment Status
Employed13 (68)16 (54)29 (59)11 (48)0.481^
Unemployed/Unpaid work/ Supported by social services3 (16)10 (33)13 (27)6 (26)
Retired3 (16)4 (13)7 (14)6 (26)
Number of intervention contacts *
3 or more19 (100)28 (93)47 (96)2 (9)0.000^
Less than 30 (0)2 (7)2 (4)21 (91)
Median (IQR)9 (4–10)8 (4–10)8 (4–10)1 (0–1)0.000
Place of birth
Sweden10 (53)6 (20)16 (33)5 (21)0.342^
Outside Sweden9 (47)24 (80)33 (67)18 (79)

*median,

^ Chi-square test,

† Kruskal-Wallis test,

**n = 21,

***n = 40,

‡ n = 19, SEK: Swedish kronor.

IQR: Interquartile range.

p-values compare the difference between the acceptability and excluded study sample.

*median, ^ Chi-square test, † Kruskal-Wallis test, **n = 21, ***n = 40, ‡ n = 19, SEK: Swedish kronor. IQR: Interquartile range. p-values compare the difference between the acceptability and excluded study sample.

Tool reliability

In total 19 items were initially included in the EFA. Two items with maximum factor loadings less than 0.40 were excluded: ‘It has been easy to find the time to participate in the program’ and ‘I have enjoyed working with my care companion(s)’. As shown in Table 5, after eliminating those items, three dimensions met extraction criteria and were retained: 1) Affective attitude and effectiveness (11 items on how the participants felt about the intervention and the extent to which the intervention was perceived as likely to achieve its purpose), 2) Coherence and understanding (4 items describing the extent to which the participants understood the intervention, how it addressed their condition and how it worked), and 3) Perceived burden (2 items on the perceived amount of effort that was required to participate in the intervention). The three factors accounted for 51%, 17% and 14% of the variance, respectively, giving a total of 82%. The Cronbach’s alpha for the respective constructs were 0.90, 0.77 and 0.85 respectively indicating an appropriate level of internal consistency for each construct [29] (Table 5).
Table 5

Factor loadings from exploratory factor analysis and respective Cronbach’s alpha scores for the final domains.

Affective attitude and effectivenessCoherence and understandingPerceived burden
This program has helped me to eat healthier0,91
The possibility for support from others besides healthcare providers is important for me0,88
I have enjoyed the discussions with the facilitator0,87
This program has helped me to increase physical activity in my daily life0,68
It has been easy to understand how this program can help me0,68
I have appreciated the activities suggested in the sessions0,66
I feel my health is better now compared to when I started the program0,65
The activities in this program have fitted well with how I want to live my life0,55
I am confident I can continue the new habits discussed with my facilitator in my daily life0,49
I am glad that I was asked to participate in this program0,47
I feel that I have achieved the goals set together with my facilitator or my care companion0,41
I feel that I have received enough information about the program0,96
The length of the sessions was not too long0,81
I feel that I have received enough information about SMART2D0,60
It has been easy and effortless to have the sessions on phone0,50
I have spent less time with my family/friends due to participation in the program0,81
I have changed my schedule to be able to participate in the coaching sessions0,76
Eigenvalue5,83,72,0
Variance explained47%30%16%
Cronbach’s alpha0.900.770.85

Note: Factor loadings < 3 are omitted from the table. (R) indicates that the item is reversely scored.

Note: Factor loadings < 3 are omitted from the table. (R) indicates that the item is reversely scored.

Acceptability of the telephone-facilitated health coaching intervention

An overview of the factor score distribution is given in Table 6. Responses to the acceptability questionnaire (in %) as reported by the participants are tabulated in S4 Appendix. The analysis showed high median scores for the standardized Likert summative scales, with a narrow interquartile range (IQR) for affective attitude and effectiveness, and coherence and understanding indicating a high acceptability of the intervention in terms of these two constructs. The opposite was seen in the third construct, perceived burden, where the median scores were low and with wide IQR, indicating an overall low perceived burden but with a wider variation in the responses. For the affective attitude and coherence and understanding, there were no significant differences found between the diagnostic groups (diabetes vs. high risk). The burden was perceived to be significantly higher among the participants in the high-risk group compared to those with T2D, and among younger participants compared to the older ones. Since high-risk participants were in general younger than the participants with diabetes (Table 4), the results were further tested for potential confounding (results not shown in tables). Both age and diagnostic groups remained, independent of each other, significant for perceived higher burden.
Table 6

Factor score distribution (median & interquartile range) for the final domains.

Affective attitude and effectivenessCoherence and understandingPerceived burden
Median (IQR)Median (IQR)Median (IQR)
Total91 (84–100)100 (81–100)0 (0–75)
n = 49
Comparison between diagnostic groups
Diabetes87 (84–95)100 (88–100)0 (0–0)
n = 19
High risk95 (86–100)100 (81–100)38 (0–88)
n = 30
P-value0.11960.70780.0036
Comparison between age groups *
Younger97 (89–100)100 (81–100)38 (0–88)
n = 26
Older86 (80–93)100 (94–100)0 (0–38)
n = 23
P-value0.00660.59100.0515

IQR: Interquartile range;

* Age groups: younger: < median age and older: >/ = median age

IQR: Interquartile range; * Age groups: younger: < median age and older: >/ = median age

Discussion

The tool based on Sekhon’s model assessed the acceptability of the SMART2D intervention using three constructs: 1) Affective attitude and effectiveness; 2) Coherence and understanding; 3) Perceived burden. Acceptability of the SMART2D intervention was high for the first two constructs (affective attitude and coherence and understanding). Although the perceived burden remained relatively low among all participants, there were more variation with younger individuals and those at high-risk, showing a higher perceived burden compared to older individuals and those with T2D respectively.

Affective attitude and effectiveness

The findings suggest a strong overall positive affect construct which includes affective elements related to the intervention process as well as to the outcomes [30]. This construct alone explained 47% of the variance in the acceptance measure (Table 5), which indicate that the intervention can be seen as acceptable from this standpoint. However, it also raises the question of whether positive affect, as induced by the contact with the facilitator and by the outcomes of the coaching, is a sufficient measure for acceptance. Even though the telephone coaching was found acceptable, some participants would have preferred in-person coaching [9]. At the same time, the telephone coaching sessions provided by SMART2D were tailored to the individual. Also, a sense of relationship was established between facilitators and participants early on in the process as a high proportion of participants reported enjoying their discussions with the facilitator (S2 Appendix). Both of these aspects could be advantages for telephone-facilitated coaching compared to automated calls [9, 31]. The difference in age groups reported in Table 6 showed that scores for this construct was significantly higher among younger persons compared with the older participants.

Coherence and understanding

The purpose of the health coaching program was perceived as clear and relevant to the participants which indicates that both the information about the project SMART2D and session content were sufficient for them to understand and internalize the objective of the intervention, making it possible to operationalize it in practice [32]. Operationalization of a theorized or conceptualized activity further brings into play a host of unknown variables and interactions, pertaining to the intervention itself, the intended population and the context in which the activity is implemented [4, 33–37]. Different starting points for lifestyle behaviors in terms of awareness and current practices [38, 39] and the different environmental cues and social support for these activities [11] could also potentially influence this domain. Duration and frequency of sessions have been found important in health coaching interventions [40]. A synthesis of reviews and meta-analyses considering health education related interventions mostly delivered face-to-face concluded that the recommended duration of sessions for patients with T2D should be more than 30 min per time per week [41]. One question within this domain addressed the participants’ perception of the duration of the sessions, but did not clarify whether the duration of the sessions could have been considered as too short. We cannot therefore assess whether the participants would in fact have preferred longer sessions.

Perceived burden

While the overall score for this construct was low, the intervention was perceived as more burdensome by individuals in the high-risk group (Table 6). Participants with T2D in our study were already familiar with lifestyle advice through their primary health care centers. As they were most likely already engaged at least in some activities for lifestyle modification, the intervention per se was not perceived as a burden to the same extent as those with high risk, for whom the activities may have been new. Moreover, persons at risk of diabetes in general are unlikely to have considered themselves to be ill [38, 39]. Therefore, all efforts towards lifestyle modification could have been perceived as something extra and requiring a greater effort [38, 39]. At the same time this group may be in greater need of support for lifestyle modification, since they do not have the same opportunity for support from primary care as individuals with T2D [42, 43]. Although the affective attitude and effectiveness was high among younger participants (Table 6), the intervention was perceived to be more burdensome among younger participants. Similar findings confirming a high burden for younger persons, were found in other studies showing higher participation numbers for older compared to younger participants in lifestyle interventions for diabetes prevention [44]. Older participants are also more likely to adhere to laboratory tests and have higher self-monitoring rates and adherence for taking medication [44, 45]. Younger participants have also shown to have poorer glucose control and persons with early‐onset of T2D in younger ages have a higher prevalence of most clinical and behavioral risk factors, such as physical inactivity, tobacco smoking and obesity [46]. Both automated telephone coaching and in-person coaching have been found more effective for older participants [45]. Considerations to reduce the burden of participation to address the needs of younger participants [44] in terms of frequency [47], and tailoring of structure and content of interventions [48] are both indicated while designing interventions for lifestyle modification.

Strengths and limitations

This study was nested in a feasibility implementation trial, making the results valid under real-life conditions for the target population and study setting. This has positive implications for further development and testing of this intervention among socioeconomically disadvantaged populations and suburbs in Sweden. Although our empirical test on the 19 questions did not confirm the seven theoretically distinct constructs, it is most likely that all of them are represented in the three constructs as the dimensions are interlinked in practice and overlapping in peoples thinking and experience. There could potentially be more dimensions that we missed due to limited number of our participants. The study would benefit to be repeated with more participants to see if the results are replicated. In terms of quality, the 5 point Likert scale format used in this study is preferred to 7 or 11 point scales [49]. However, one risk in agree-disagree scales is the acquiescence response bias, where it is more common that participants agree than disagree with the statement offered regardless of its content [50, 51]. That could have been the case in our study as well. Similarly, social desirability bias could also be relevant, with the acceptability survey being administered by the same project, of which they were a part. However, precautions were taken to minimize this bias through the collection of acceptability data by a research assistant, unfamiliar with the intervention and to the participants. The participants of the acceptability survey had in general a higher number of intervention contacts compared to the non-participants (Table 4). This could indicate that the group who reported the acceptability was in general more positive to the intervention than those who discontinued the intervention for any reason. Qualitative interviews with participants who discontinued the intervention would have been valuable to understand how they viewed the intervention and its acceptability.

Conclusions

We found that the telephone-facilitated health coaching intervention was perceived as acceptable by the study population in socioeconomically disadvantaged suburbs of Stockholm, using a tool based on Sekhon’s theoretical framework of acceptability. Though acceptable, participation in a lifestyle intervention was found to be more burdensome for persons at high risk of developing diabetes and for younger participants. The individually tailored telephone coaching seemed therefore to be a suitable approach especially for people already living with type 2 diabetes in this population. This is also one of the initial attempts at a survey-based tool to assess acceptability for this type of behavior change interventions, and hence a work in progress, which needs to be refined further.

TIDieR-checklist.

(DOCX) Click here for additional data file.

SMART2D intervention guide_points of contact and SOPs SWEDISH.

(PDF) Click here for additional data file.

SMART2D intervention guide _points of contact and SOPs ENGLISH.

(PDF) Click here for additional data file.

Reported responses.

(DOCX) Click here for additional data file.

SMART2D acceptability raw data.

(XLSX) Click here for additional data file. 3 Dec 2020 PONE-D-20-32022 Application of the Theoretical Framework of Acceptability to assess a telephone-facilitated health coaching intervention for the prevention and management of type 2 diabetes PLOS ONE Dear Dr. Timm, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Jan 17 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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We will update your Data Availability statement on your behalf to reflect the information you provide. 4.) Thank you for stating the following in the Financial Disclosure section: 'This study is part of the SMART2D project supported by the EU Horizon 2020 Health Coordination Activities (Grant Agreement No 643692), MD, under call HCO-05-2014 (Global Alliance for Chronic Diseases: Prevention and treatment of type 2 diabetes) URL: https://ec.europa.eu/programmes/horizon2020/en/h2020-sections-projects; and partially funded by Region Stockholm’s Public Healthcare Services Administration (Hälso- och sjukvårdsförvaltningen), URL: https://www.sll.se/om-regionstockholm/Organisation/forvaltningar/halso-och-sjukvardsforvaltningen/. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.' We note that one or more of the authors are employed by a commercial company: Collaborative Care Systems Finland a. Please provide an amended Funding Statement declaring this commercial affiliation, as well as a statement regarding the Role of Funders in your study. If the funding organization did not play a role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript and only provided financial support in the form of authors' salaries and/or research materials, please review your statements relating to the author contributions, and ensure you have specifically and accurately indicated the role(s) that these authors had in your study. You can update author roles in the Author Contributions section of the online submission form. Please also include the following statement within your amended Funding Statement. “The funder provided support in the form of salaries for authors [insert relevant initials], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.” If your commercial affiliation did play a role in your study, please state and explain this role within your updated Funding Statement. b. Please also provide an updated Competing Interests Statement declaring this commercial affiliation along with any other relevant declarations relating to employment, consultancy, patents, products in development, or marketed products, etc. Within your Competing Interests Statement, please confirm that this commercial affiliation does not alter your adherence to all PLOS ONE policies on sharing data and materials by including the following statement: "This does not alter our adherence to  PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests) . If this adherence statement is not accurate and  there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. c. Please include both an updated Funding Statement and Competing Interests Statement in your cover letter. We will change the online submission form on your behalf. Please know it is PLOS ONE policy for corresponding authors to declare, on behalf of all authors, all potential competing interests for the purposes of transparency. PLOS defines a competing interest as anything that interferes with, or could reasonably be perceived as interfering with, the full and objective presentation, peer review, editorial decision-making, or publication of research or non-research articles submitted to one of the journals. Competing interests can be financial or non-financial, professional, or personal. Competing interests can arise in relationship to an organization or another person. Please follow this link to our website for more details on competing interests: http://journals.plos.org/plosone/s/competing-interests 5.) Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information Additional Editor Comments: Abstract: it would be good to have participant numbers in the method, and a brief description of who the participants were: for example, age, gender and SES in the results. The conclusion could flow better. Introduction: it would be good to reference the new scale in the second aim. Method: How long is each intervention session? On lines 157 to 159, it is a bit confusing with regards to which language the sessions were presented in. More detail is required about the face to face meetings (for example, how often/how long?). In Table 2, Session 4, is the change over the years in relation to individual or population physical activity? The data analysis only appears to describe factor analysis and not application of the tool to assess acceptability (or if it does do the latter then could this be stated more explicitly?) Results: it would be good to have employment status and income level for participants presented. And, if appropriate, do some analysis of the factor score distribution in relation to these. Discussion: line 289, I am not sure of the point of discussing smiley faces – could its relevance be made clearer? It would have been useful to have some more detail of studies 44 and 45. Given the low participant number, should the study be repeated with more participants to see if the results are replicated? [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No ********** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes ********** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ********** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The data analysis section needs more clarity. Line 199: Please specify the type of correlation used to estimate the correlation matrix and justify the choice. Lines 203-204: The KMO test was used but the criteria used to determine appropriateness has not been specified. Line 208: It is not clear what m and k stand for. This has not been defined in the analysis section. Lines 208-209: Please clarify what differences were being tested using the Wilcoxon rank sum test and its role in evaluating the psychometric properties of the scale. Please justify why were unidimensionality and validity (content, criterion, construct, convergent and divergent) not evaluated. ********** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. 15 Jan 2021 Dear Editors! Our responses are provided in a table format uploaded as a separate document. Please contact me if you want me to enter our responses in this text box (needs to be edited to fit in). Thank you, Linda Timm linda.timm@ki.se Submitted filename: Response to Reviewers.docx Click here for additional data file. 10 Sep 2021
PONE-D-20-32022R1
Application of the Theoretical Framework of Acceptability to assess a telephone-facilitated health coaching intervention for the prevention and management of type 2 diabetes
PLOS ONE Dear Dr. Timm, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.
 
To ensure completeness of methodological reporting, please provide the additional details requested by Reviewer 2.
 
Please submit your revised manuscript by Oct 24 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript:
If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Jamie Males Staff Editor PLOS ONE Journal Requirements: Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #2: (No Response) ********** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #2: Yes ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: Yes ********** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #2: Yes ********** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #2: Yes ********** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #2: The aims of the cluster randomized design research study were to develop and assess the psychometric properties of measurement scale for acceptance of telephone-facilitated health coaching intervention based on Theoretical Framework Acceptability (TFA), and to determine the acceptability of the intervention among participants living with diabetes or having a high risk of diabetes in socioeconomically disadvantaged areas of Stockholm. The Exploratory Factor Analysis on the acceptability scale revealed three factors with acceptable reliabilities: affective attitude (alpha 0.90), coherence and understanding (alpha 0.77), perceived burden (alpha 0.85), explaining 82% of the variance. Minor revision: Cite the statistical software used for the analysis. ********** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #2: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.
18 Oct 2021 Dear Reviewer, We are thankful for your suggestions on revisions to improve our manuscript. Details on the revisions can be found in the attached file "Respons to Reviewers". Thank you! Kind regards, Linda Submitted filename: Response to Reviewers_PLOSOne_Timm L. et al.docx Click here for additional data file. 29 Jun 2022
PONE-D-20-32022R2
Application of the Theoretical Framework of Acceptability to assess a telephone-facilitated health coaching intervention for the prevention and management of type 2 diabetes
PLOS ONE Dear Dr. Timm, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Aug 12 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript:
A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Miquel Vall-llosera Camps Senior Editor PLOS ONE Additional Editor Comments: Apologies for the delay in providing this review and for the new reviews at this stage, but due to the clinical implications of this study it was considered necessary to invite additional reviewers to assess the manuscript. Reviewer 3 comments should be straightforward to address. Reviewer 5 comments about the introduction and discussion are optional (as these are not required to meet our publication criteria), but the comments about the methods and results are necessary and should be straightforward too. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #2: All comments have been addressed Reviewer #3: (No Response) Reviewer #4: All comments have been addressed Reviewer #5: (No Response) ********** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #2: (No Response) Reviewer #3: Yes Reviewer #4: Yes Reviewer #5: Yes ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: (No Response) Reviewer #3: Yes Reviewer #4: I Don't Know Reviewer #5: Yes ********** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #2: (No Response) Reviewer #3: Yes Reviewer #4: Yes Reviewer #5: Yes ********** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #2: (No Response) Reviewer #3: Yes Reviewer #4: Yes Reviewer #5: Yes ********** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #2: (No Response) Reviewer #3: This is an interesting paper on the psychometric property of TFA scale. Although the sample size is relatively small, the analytical approach to relevant theoretical constructs offers some evidence of the validity and reliability of the measurement indicators. The paper has adequately addressed the standard procedure used in the evaluation of psychometric property of measurement items. Two suggestive amendments are as follows: 1. Exploratory Factor Analysis: Are you assuming that the five theoretical constructs are independent? Are the five constructs correlated with each other? 2. Limitation of EFA: Originally, there were seven constructs developed for TFA. However, only five constructs appear to show the relevance to TFA. The EFA procedure is sensitive to the variations in the samples selected. In other words, how can investigators handle the potential biases introduced by the sample? Reviewer #4: Thank you for the opportunity to review. I would be happy to state that this publication may be accepted as is. Reviewer #5: Thank you for the opportunity to review this manuscript on the acceptability of a telephone-facilitated health coaching intervention. It appears that this is a resubmission; however, I did not review the first version. Therefore, my comments are new to the authors. Overall, the manuscript’s methods and results are well described. The greatest attention in the revisions should be paid to the introduction framing the study and the discussion of its findings. I have summarized needed revisions by sections below. Introduction: The introduction needs some restructuring. An outline that would make more sense is: 1. Discuss diabetes and the self-management it requires. 2. Discuss self-management benefits for T2D. 3. Discuss challenges to doing self-management activities – these include social determinants of health, treatment burden, and patient capacity. 4. Discuss health coaching as an intervention to potentially overcome these challenges. 5. Discuss potential challenges to implementation of telephone health coaching, including acceptability. 6. Discuss acceptability specifically. 8. Discuss TFA as a way to assess acceptability and why it is useful. 7. Lay out the aims. Line 71. First sentence needs citations. Methods: Please note the training of the trained facilitators specifically. Table 2, session content notes “peer” in the description. Did the study use peer coaches? If peers, it need to specifically state throughout that the intervention of interest is peer coaching. Peer coaching is not currently covered within the standardized definition of Health and Wellness Coaching, which is currently driving practice changes, including reimbursement, in the US Setting. (Wolever 2013 in Global advances in Health and Medicine; Wolever 2016 in BMC Health Services Research). Please describe the amount of missingness led to surveys being excluded from the analysis (n=6). Results: I don’t think that “excluded from the acceptability study” is the right terminology. If I am reading methods correctly, only 6 were excluded due to missingness. The others chose not to participate in the acceptability study portion. Therefore, I think something like “intervention completed; declined acceptability study” is more appropriate. The 6 that didn’t fully complete the data collection of the acceptability study could still be labelled as excluded. Discussion: In the first paragraph, your summary of findings, please add a statement that relates to your first aim. Currently, the summary primarily focuses on the second aim. Similarly, the discussion pays very little attention to the scale that was developed. While understandable that the scale served a purpose to evaluate the intervention, significant attention was devoted to it in the methods and results sections. It would be helpful to highlight future uses of the scale – is it only possible to use it with this specific intervention or could it be applicable (as is or tailored) to other coaching or self-management interventions as well? You note in results that the intervention was more burdensome to younger individuals. This is in alignment with treatment burden in general. Across populations, younger patients report higher levels of treatment burden. See work by Tran VT and Eton DT. This should be noted in the section on burden. It would be helpful to add a section that specifically addresses implications of the study for practice and for research. ********** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #2: No Reviewer #3: Yes: Thomas T.H. Wan Reviewer #4: No Reviewer #5: Yes: Kasey R. Boehmer ********** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. 27 Aug 2022 Response to Reviewers Thank you for your valuable comments. Please see our response and revisions below. Reviewer #3: Two suggestive amendments are as follows: 1. Exploratory Factor Analysis: Are you assuming that the five theoretical constructs are independent? Are the five constructs correlated with each other? Response to suggestive amendment 1: The items in the different theoretical constructs are correlated with each other as reported in the correlation matrix of the data. The original constructs are all part of the Theoretical Framework of Acceptability as discussed in the text. Further, the EFA has retained the most relevant items to our acceptability dimensions representing what we believe are the participants’ thinking and experience of the intervention. 2. Limitation of EFA: Originally, there were seven constructs developed for TFA. However, only five constructs appear to show the relevance to TFA. The EFA procedure is sensitive to the variations in the samples selected. In other words, how can investigators handle the potential biases introduced by the sample? Response to suggestive amendment 2: It is possible that with a larger sample we would have been able to keep a larger number of items and therefore a more detailed representation of the original seven constructs of the TFA. However, the sampling adequacy test showed that the data used in our analyses was adequate to perform EFA, the items included in this study and the obtained constructs were relevant and showed validity to our acceptability study. Reviewer #5: Methods: Please note the training of the trained facilitators specifically. Table 2, session content notes “peer” in the description. Did the study use peer coaches? If peers, it need to specifically state throughout that the intervention of interest is peer coaching. Peer coaching is not currently covered within the standardized definition of Health and Wellness Coaching, which is currently driving practice changes, including reimbursement, in the US Setting. (Wolever 2013 in Global advances in Health and Medicine; Wolever 2016 in BMC Health Services Research). Response: Thank you for this valuable comment. It was not correct to use “peer” in Table 2. We have clarified this by replacing the word peer to the more adequate word care companion, which is also used in the descriptive text. Please describe the amount of missingness led to surveys being excluded from the analysis (n=6). Response: Revision on page 9. To clarify the amount of missingness, the number is corrected to 5 in the text, now corresponding to the numbers in the figure. Results: I don’t think that “excluded from the acceptability study” is the right terminology. If I am reading methods correctly, only 6 were excluded due to missingness. The others chose not to participate in the acceptability study portion. Therefore, I think something like “intervention completed; declined acceptability study” is more appropriate. The 6 that didn’t fully complete the data collection of the acceptability study could still be labelled as excluded. Response: Thank you for this comment, the terminology is revised both in the text and in the table for clarification (pages 10-11). Please note the comment above on the revised number. We have considered the comments about introduction and discussion from Reviewer 5. These revisions are according to editors optional and we have chosen to leave these parts as they have been thoroughly revised earlier according to previous reviewers comments. Line 71: Citation marks have been added to the first sentence. Line 369: An ‘i’ was missing after the word interlinked and this is corrected. Table 4 on page 1. ‘of’ has been changed to ‘or’. Submitted filename: Response to Reviewers.docx Click here for additional data file. 20 Sep 2022 Application of the Theoretical Framework of Acceptability to assess a telephone-facilitated health coaching intervention for the prevention and management of type 2 diabetes PONE-D-20-32022R3 Dear Dr. Timm, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Kingston Rajiah Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #2: All comments have been addressed Reviewer #3: All comments have been addressed ********** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #2: (No Response) Reviewer #3: Yes ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: (No Response) Reviewer #3: Yes ********** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #2: (No Response) Reviewer #3: Yes ********** 5. Is the manuscript presented in an intelligible fashion and written in standard English? 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1.  Criteria for evaluating psychotherapy.

Authors:  A E Kazdin; G T Wilson
Journal:  Arch Gen Psychiatry       Date:  1978-04

2.  Effectiveness of an Adapted Diabetes Prevention Program Lifestyle Intervention in Older and Younger Adults.

Authors:  Sarah M Brokaw; Dorota Carpenedo; Paul Campbell; Marcene K Butcher; Ginny Furshong; Steven D Helgerson; Todd S Harwell
Journal:  J Am Geriatr Soc       Date:  2015-06-01       Impact factor: 5.562

3.  Prevention of type 2 diabetes in a primary health care setting. Interim results from the Greater Green Triangle (GGT) Diabetes Prevention Project.

Authors:  Annamari Kilkkinen; Sami Heistaro; Tiina Laatikainen; Edward Janus; Anna Chapman; Pilvikki Absetz; James Dunbar
Journal:  Diabetes Res Clin Pract       Date:  2006-10-27       Impact factor: 5.602

4.  SMART2D-development and contextualization of community strategies to support self-management in prevention and control of type 2 diabetes in Uganda, South Africa, and Sweden.

Authors:  Pilvikki Absetz; Josefien Van Olmen; David Guwatudde; Thandi Puoane; Helle Mölsted Alvesson; Peter Delobelle; Roy Mayega; Francis Kasujja; Gloria Naggayi; Linda Timm; Mariam Hassen; Juliet Aweko; Jeroen De Man; Jhon Álvarez Ahlgren; Kristi Sidney Annerstedt; Meena Daivadanam
Journal:  Transl Behav Med       Date:  2020-02-03       Impact factor: 3.046

Review 5.  Health education for patients with acute coronary syndrome and type 2 diabetes mellitus: an umbrella review of systematic reviews and meta-analyses.

Authors:  Xian-Liang Liu; Yan Shi; Karen Willis; Chiung-Jung Jo Wu; Maree Johnson
Journal:  BMJ Open       Date:  2017-10-16       Impact factor: 2.692

6.  Patient and Provider Dilemmas of Type 2 Diabetes Self-Management: A Qualitative Study in Socioeconomically Disadvantaged Communities in Stockholm.

Authors:  Juliet Aweko; Jeroen De Man; Pilvikki Absetz; Claes-Göran Östenson; Stefan Swartling Peterson; Helle Mölsted Alvesson; Meena Daivadanam
Journal:  Int J Environ Res Public Health       Date:  2018-08-22       Impact factor: 3.390

Review 7.  Context matters in implementation science: a scoping review of determinant frameworks that describe contextual determinants for implementation outcomes.

Authors:  Per Nilsen; Susanne Bernhardsson
Journal:  BMC Health Serv Res       Date:  2019-03-25       Impact factor: 2.655

8.  The dynamic sustainability framework: addressing the paradox of sustainment amid ongoing change.

Authors:  David A Chambers; Russell E Glasgow; Kurt C Stange
Journal:  Implement Sci       Date:  2013-10-02       Impact factor: 7.327

9.  Early detection of type 2 diabetes in socioeconomically disadvantaged areas in Stockholm - comparing reach of community and facility-based screening.

Authors:  Linda Timm; Katri Harcke; Ida Karlsson; Kristi Sidney Annerstedt; Helle Mölsted Alvesson; Nouha Saleh Stattin; Birger C Forsberg; Claes-Göran Östenson; Meena Daivadanam
Journal:  Glob Health Action       Date:  2020-12-31       Impact factor: 2.640

10.  Solving the Puzzle to Lasting Impact of the National Diabetes Prevention Program.

Authors:  Natalie D Ritchie
Journal:  Diabetes Care       Date:  2020-09       Impact factor: 19.112

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