| Literature DB >> 26844102 |
A S Gilinsky1, A F Kirk1, A R Hughes1, R S Lindsay2.
Abstract
PURPOSE: To systematically review lifestyle interventions for women with prior Gestational Diabetes Mellitus (GDM) to report study characteristics, intervention design and study quality and explore changes in 1) diet, physical activity and sedentary behaviour; 2) anthropometric outcomes and; 3) glycaemic control and diabetes risk.Entities:
Keywords: Gestational diabetes; Lifestyle; Review
Year: 2015 PMID: 26844102 PMCID: PMC4721374 DOI: 10.1016/j.pmedr.2015.05.009
Source DB: PubMed Journal: Prev Med Rep ISSN: 2211-3355
Fig. 1Flow of search and selection process.
Notes.
aMay include duplicates of some records identified though the cited reference search had already been considered following the database search.
bIn-pregnancy interventions were excluded if the outcomes were reported in-pregnancy only. We considered interventions that recruited/began in pregnancy if the outcomes were postpartum.
c14 authors were contacted to check for peer-reviewed published manuscripts. Seven did not respond, four advised no published information was available, two linked us to papers already identified and one provided a new paper.
dFour authors were contacted to request information regarding the subset of GDM women from their sample and five to request further information for completeness of data extraction. Information was not provided in six cases, resulting in four articles being excluded from the review.
Risk of bias among included studies.
| Author(s), year | Sequence generation | Concealed allocation | Outcome assessment | Loss-to follow-up | Missing data handling | Overall risk of bias | Rationale for overall risk |
|---|---|---|---|---|---|---|---|
| Cheung, 2007 ( | N/A | N/A | U | A | A | High | Pre–post study lacking randomly allocated control |
| Cheung, 2011 ( | U | U | U | A | N | Unclear | Unclear how participants were allocated and randomised and extent of concealment. Low number included in the analysis. |
| Ferrara, 2011 ( | A | A | A | A | A | Low | All quality criteria adequate. |
| Hu, 2012 ( | U | U | U | A | A | Unclear | Early results suggest low drop-out from study, randomisation after all baseline assessments completed but unclear whether allocation was concealed. |
| Kim 2012 ( | A | A | A | A | A | Low | All quality criteria adequate. |
| McIntyre, 2012 ( | U | U | U | A | N | Unclear | Unclear how participants were allocated and randomised and extent of concealment |
| Peterson, 1995 ( | U | U | U | N | U | Unclear | Main study indicators unclear |
| Philis-Tsimikas, 2014 ( | N/A | N/A | U | N | N | High | Pre–post study lacking randomly allocated control |
| Ratner, 2008 ( | A | A | A | A | A | Low | All quality criteria adequate with low loss-to-follow-up and ITT used. |
| Reinhardt et al, 2012 ( | U | N | N | A | A | High | Randomisation to groups known by researcher (and possibly participants) prior to baseline assessments |
| Shyam et al, 2013 ( | A | U | U | A | A | Unclear | Unclear whether allocation to groups was adequately concealed and whether anthropometric and/or dietary outcome |
| Shek et al, 2014 ( | A | U | A | A | U | Unclear | Unclear whether allocation to trial arms was concealed prior to baseline assessments or how loss-to-follow up data was imputed. |
| Wein, 1999 ( | U | U | U | A | A | Unclear | Unclear how participants were allocated and randomised and extent of concealment |
A, adequate; ITT, intention-to-treat; N, not adequate; U, unclear, N/A, not applicable
Note.
Lack of blinding likely to affect self-report behavioural measures/waist or hip measurements but not weight/objective physical activity outcomes.
92% retention at one year for the first 444 participants recruited into the study.
Limited information on how behavioural or weight outcomes were assessed, mentions anthropometric testing and online survey only.
Unclear how weight, waist and hip measurements taken, drop-out at 6 weeks 24% and at 12 weeks 32%.
Double blinded for drug/placebo groups, investigators masked to treatment assignment unless diabetes diagnosis confirmed.
Other possible threat to validity is the use of multiple tests for weight, anthropometry and diet measure.
States ITT for diabetic outcomes but not clear for weight outcomes; there was a low loss to follow-up rate, with a further small proportion becoming pregnant.
Study characteristics, efficacy outcomes and risk of bias for included studies.
| Author [ref], country | Design, aim, setting duration, follow-up | Study population | Intervention, adherence and comparator condition | Outcome measures | Efficacy for all outcomes (last follow-up point) | Bias risk |
|---|---|---|---|---|---|---|
| Cheung ( | RCT | N = 43 | Intervention: face-to-face 1 hour counselling session then goal-directed phone calls at 2, 6 and 10 weeks, then 26 and 34 weeks. Pedometers for setting and monitoring goals. 7 postcards with messages to reinforce change. | PA: AWAS and Yamax Digiwalker pedometer | 30.8%) (4/13) in the intervention group met the | Unclear |
| McIntyre ( | RCT | N = 28 | Intervention: initial face-to-face consultation for initiation followed by weekly (4 weeks) then bi-weekly (8 weeks) calls for maintenance | PA: AWAS | Intervention group increased PA by 60 mins/week, among controls 0 min/week change (NS difference between the groups, p = 0.23) | Unclear |
| Kim ( | RCT | N = 49 | Intervention: online delivery of a pedometer programme. Weekly stepcount recorded. Interaction via message boards, email/text feedback. Based on self-regulation, risk perception. | PA: questionnaire and pedometer readings | No between groups differences on proportion achieving > 60 mins/week of total, mild, moderate or vigorous PA. | Low |
| Peterson ( | RCT cross-over design | N = 25 | Intervention: face-to-face weekly/bi-weekly. Dietary prescription (40% or 55% CBH) with supplements Participants maintained food diary. | Anthropometric: weight and %bodyfat Glycaemic: serum fasting insulin (mU/L) | Weight loss occurred in both groups at 6 weeks (p ≤ 0.03). with further weight loss at 12 weeks NS (p-value unreported) | Unclear |
| Wein ( | RCT | N = 200 | Intervention: initial face-to-face contact then calls every three months. Advised to exercise regularly. No behaviour change theory. | PA & diet: questionnaire | Increase in diet score in both group. No change in mean exercise score in either group from baseline. Increase in BMI, FBG & 1-hour BG from baseline to last follow-up point in both groups (p-value NG). Reduction in 2-hour BG (intervention) & increase (controls) (p < 0.02). | Unclear |
| Ratner ( | RCT (3-group design) | N = 350 | Intervention: DPP lifestyle intervention using curriculum based on modification concepts from behavioural theory Individual 30 min session then calls (16 sessions in the first 24 weeks then monthly contact). Weekly group exercise classes and after 24 weeks group education classes quarterly. | PA: Modifiable activity questionnaire | Increase in METhours/week in lifestyle intervention group compared with baseline (not sustained at 3 years). Change in dietary measures not reported. | Low |
| Shyam ( | RCT | N = 77 | Intervention: 1 face-to-face session with meal plans to follow at home. Also encouraged to be physically active for 30 min (at least 5 times/week) | PA: IPAQ | Difference between groups favouring the LGI intervention on dietary fibre intake, glycaemic index, glycaemic load, % protein intake and % carbohydrates intake | Unclear |
| Ferrara ( | RCT | N = 197 | Intervention: prenatal face-to-face 1 hour dietary counselling session and 2 phone calls. Encourage to accumulate 150 mins/week of PA. One 1 hour breastfeeding counselling session then 1–4 calls in first 6 weeks PP. After six weeks PP 16 sessions (2 in-person) and 6–16 calls then 3 maintenance calls. | PA: 7-DAY PAR | No difference between the groups in MVPA (p = 0.91) | Low |
| Cheung ( | Pre–post | N = 25 | Intervention: weekly face-to-face classes plus 40–50 mins of supervised exercise and pedometers, newsletters and telephone contacts used. Free childcare provided. No theory mentioned. | PA: active Australia Questionnaire | Median walking increased (15 to 105 mins/week, p < 0.01). Vigorous activity and LTPA increases were NS. | High |
| Hu ( | RCT | N = 1180 | Intervention: two-week with two face-to-face education classes. Then personalised dietary/PA advice and 5-day meal plan, exercise goals, delivered face-to-face and calls for one year (minimum 5 contacts in year 1) with goal-monitoring. Then 2 face-to-face contacts and 2 calls in year two. No theory mentioned. | PA: self reported | % of participants increasing LTPA higher among the intervention group (59% vs 27%). Reduction in sitting time in intervention group and increase among controls, | Unclear |
| Philis-Tsimikas ( | Pre–post study | N = 84 | Intervention: 8 weekly 2 hour culturally sensitive group education sessions (5–12 participants) with 15–20 min PA. | PA: Rapid PA assessment | Increase in the proportion of participants who were active for ≥ 30 mins 5/week (from 52% to 69%, p < 0.05). Increase in the proportion of participants doing any strength/flexibility training (from 18% to 64%, p < 0.01) | High |
| Reinhardt ( | RCT | N = 38 | Intervention: 10 calls: weekly (5 weeks) then monthly (5 months). Self-help booklet. Reviewed behaviours/barriers at calls. Offered 2 exercise classes/week. Based on determinants (benefits, perceived barriers, SS etc.) using MI. | PA: IPAQ | Difference between groups favouring the intervention on LTPA | High |
| Wan Man Shek ( | RCT | N = 450 | Intervention: one face-to-face lifestyle consultation repeated every three months up to 36 months. Individualised calculation of calorie intake with monitoring of food and PA by diaries (checked at visits). No behavioural theory mentioned. | Anthropometric: | Reduction in %body fat, triglycerides, SBP at last follow-up in the intervention. No difference in BMI & WHR at last follow-up in the intervention group from baseline. No differences in conversion rate to T2DM. Among subgroup of women > 40 years old a reduction in conversion rate favoured the intervention group. | Unclear |
7-DAY PAR, Seven Day Physical Activity Recall; ADA, American Dietary Association; AWAS, Australian Women's Activity Survey; BMI, body mass index; CI, confidence interval; CNNHS, China National Nutrition and Health Survey; BP, blood pressure DBP, diastolic blood pressure; SBP, systolic blood pressure, DPP, Diabetes Prevention Program; FBG, fasting blood glucose, FFQ, food frequency questionnaire; GDM, gestational diabetes mellitus; GWG, gestational weight gain; HDL-C, high-density lipoprotein; IGT, impaired glucose tolerance, IOM, Institute of Medicine; IPAQ, International Physical Activity Questionnaire; LDL-C, low-density lipoprotein; LTPA, leisure-time physical activity; mins, minutes; motivational interviewing, MI; MVPA, moderate–vigorous physical activity; NA, not applicable; NG, not given; NS, non-statistically significant; PA, physical activity; PP, postpartum; RCT, randomised controlled trial; SCT, socio-cognitive theory; T2DM, type 2 diabetes mellitus; WHR, waist–hip ratio.
Note.
All studies excluded women with current diagnosis of type 2 diabetes mellitus.
Determined by questionnaire and pedometer readings > 62,000 steps/week.
Prenatal targets: GWG in line with IOM guidelines (or not greater than 11.4 kg), follow the ADA diet (i.e. low fat, low glycaemic index); engage in 150 mins/week moderate PA.
Number enrolled in the study, this paper reports data for the first 394 participants who completed one year data assessments at the end of November 2011.
Participants were women with a history of GDM and were part of the larger DPP trial and were not comparable to women with at least one live birth without a history of GDM in terms of age but were comparable on ethnicity, BMI and number of live births.
Complete list of exclusions and study retention rate for the DPP is provided by Knowler et al., (2009).
Fig. 2Meta-analysis of weight loss.
Fig. 3Meta-analysis of fasting blood glucose change.