| Literature DB >> 31766666 |
Silvia Costa1,2, Sara E Benjamin-Neelon1,3, Eleanor Winpenny1, Veronica Phillips4, Jean Adams1.
Abstract
The rising prevalence of childhood obesity is a global public health concern. Evidence suggests that exposure to non-parental childcare before age six years is associated with development of obesity, diet, and activity behaviours (physical activity, sedentary behaviour, and sleep). However, findings are inconsistent and mostly from cross-sectional studies, making it difficult to identify the direction of causation in associations. This review identified and synthesised the published research on longitudinal associations between non-parental childcare during early childhood, diet, and activity behaviours. Seven databases were searched, and results were independently double-screened through title/abstract and full-text stages. Included studies were evaluated for risk of bias. Of the 18,793 references screened, 13 met eligibility criteria and were included in the review. These presented results on 89 tested childcare/outcome associations, 63 testing diet outcomes (59% null, remainder mixed), and 26 testing activity behaviour outcomes (85% null, remainder mixed). The scarce available literature indicates little and mixed evidence of a longitudinal association. This reflects a paucity of research, rather than clear evidence of no effect. There is an urgent need for studies investigating the longitudinal associations of non-parental childcare on diet and activity behaviours to assess potential lasting effects and mechanisms; whether and how effects vary by provider; and differences by intensity, duration, and population sub-groups.Entities:
Keywords: activity behaviours; dietary behaviours; early care and education; early childhood; obesity risk factors
Mesh:
Year: 2019 PMID: 31766666 PMCID: PMC6926528 DOI: 10.3390/ijerph16234652
Source DB: PubMed Journal: Int J Environ Res Public Health ISSN: 1660-4601 Impact factor: 3.390
Figure 1Eligibility criteria.
Figure 2PRISMA diagram.
Description of included studies.
| Study (Date) | Location | Sample Size | Study Design | Sex | Ethnicity/Country of Birth | Outcome |
|---|---|---|---|---|---|---|
| Belfield & Kelly (2013) [ | USA | 6550 | Prospective longitudinal cohort study (Early Childhood Longitudinal Survey—Birth Cohort) | Preschool: 4124 (50.6%) girls, 4026 (49.4%) boys * | Preschool: 1231 (15.1%) Black, 1157 (14.2%) Hispanic, 864 (10.6%) Asian, 1410 (17.3%) Other non-White, 3488 (42.8%) White | Physical activity, diet |
| Cairns & Harsh (2014) [ | USA | 34 | Prospective longitudinal study | 15 (44.1%) girls, | 62% White, 32% Black, 6% Other | Sleep |
| D’Onise et al. (2011) [ | Australia | 1063 | Prospective longitudinal cohort study (North West Adelaide Health Study) | 580 (54.6%) girls, | Not reported | Physical activity, sedentary behaviour |
| Lumeng et al. (2005) [ | USA | 1244 | Longitudinal panel survey study | 630 (50.6%) girls, | 488 (39.2%) Black, 69 (5.5%) Hispanic, 623 (50.1%) White, 64 (5.1%) Other | Sedentary behaviour |
| Lumeng et al. (2006) [ | USA | 1016 | Prospective longitudinal study | 498 (49.0%) girls, | 841 (82.8%) White, 175 (17.2%) non-White | Sedentary behaviour |
| Taylor et al. (2009) [ | New Zealand | 3 years: 238 | Prospective longitudinal cohort study (The Family Lifestyle, Activity, Movement, and Eating study) | 3 years: 107 (43.9%) girls, 137 (56.1%) boys | Baseline: 87% Caucasian, 10.8% Maori, 3.7% Pacific Islanders | Physical activity |
| Camara et al. (2015) [ | France | 974 | Prospective longitudinal cohort study (EDEN—Etude des Déterminants pré et post natals du développement et de la santé de l’ENfant) | 454 (46.6%) girls, | France birth (ethnic composition not presented) | Diet |
| Lee et al. (2013) [ | USA | 2150 | Prospective longitudinal cohort study (Early Childhood Longitudinal Study-Birth Cohort (ECLS-B)) | 49% girls, 51% boys | USA birth (ethnic composition not presented) | Diet |
| Levy et al. (2002) [ | USA | 1387 | Prospective longitudinal cohort study (Iowa Fluoride Study) | Not reported | 95% White, 5% Other | Diet |
| Pearce et al. (2012) [ | UK | 18,050 | Prospective longitudinal cohort study (Millennium Cohort Study) | Not reported | UK birth (ethnic composition not presented) | Diet |
| Sata et al. (2015) [ | Japan | 4281 | Prospective longitudinal cohort study (Ibaraki Children’s Cohort (IBACHIL) Study) | 2042 (47.7%) girls, | Japan birth (ethnic composition not presented) | Diet |
| Wasser et al. (2013) [ | USA | 210 | Prospective longitudinal study | 116 (53.5%) girls, | African-American | Diet |
| Weile et al. (1990) [ | Denmark | 500 | Prospective longitudinal study | Not reported | Denmark birth (ethnic composition not presented) | Diet |
Legend: BMI—body mass index; SD—standard deviation. * Numbers are approximate, calculated from the percentages and total preschool and kindergarten sample sizes presented in Belfield and Kelly (2013) Appendix Table A2.
Results of included studies.
| Study | Exposure | Age at Childcare Exposure | Outcome | Age at Outcome | Analysis | Adjustment | Results (Most Adjusted Model) |
|---|---|---|---|---|---|---|---|
| Belfield & Kelly (2013) | Centre-based preschool | 4 y | Low activity level | 5–6 y | Multivariable probit regression models | Child’s race/ethnicity, gender, age, and number of siblings, twin (yes/no), maternal employment, education, and marital status, health insurance status, father non-resident, household income, geographic region, and prior health at 24 mo (general health status, and indicators of asthma, gastroenteritis, respiratory condition, and ear infection) | AME = 0.124 (SE: 0.120), |
| Centre-based preschool | 4 y | Screened low activity | 5–6 y | Multivariable probit regression models | AME = 0.056 (SE: 0.084), | ||
| Centre-based preschool | 4 y | Regular fast food consumption (vs. not) | 5–6 y | Multivariable probit regression models | AME = −0.15 (SE: 0.055), | ||
| Centre-based preschool | 4 y | Regular soda consumption (vs. not) | 5–6 y | Multivariable probit regression models | AME = −0.117 (SE: 0.056), | ||
| Centre-based preschool | 4 y | Regular candy consumption (vs. not) | 5–6 y | Multivariable probit regression models | AME = 0.031 (SE: 0.053), | ||
| Centre-based preschool | 4 y | Regular chips consumption (vs. not) | 5–6 y | Multivariable probit regression models | AME = 0.113 (SE: 0.054), | ||
| Centre-based preschool | 4 y | Infrequent vegetable consumption (vs. frequent) | 5–6 y | Multivariable probit regression models | AME = 0.049 (SE: 0.058), | ||
| Centre-based preschool | 4 y | Infrequent fruit consumption (vs. frequent) | 5–6 y | Multivariable probit regression models | AME = −0.120 (SE: 0.060), | ||
| Centre-based preschool for 2 y | 4 y | Low activity level | 5–6 y | Multivariable probit regression models | AME = 0.007 (SE: 0.173), | ||
| Centre-based preschool for 2 y | 4 y | Screened low activity | 5–6 y | Multivariable probit regression models | AME = 0.058 (SE: 0.126), | ||
| Centre-based preschool for 2 y | 4 y | Regular fast food consumption (vs. not) | 5–6 y | Multivariable probit regression models | AME = 0.022 (SE: 0.085), | ||
| Centre-based preschool for 2 y | 4 y | Regular soda consumption (vs. not) | 5–6 y | Multivariable probit regression models | AME = −0.260 (SE: 0.083), | ||
| Centre-based preschool for 2 y | 4 y | Regular candy consumption (vs. not) | 5–6 y | Multivariable probit regression models | AME = −0.031 (SE: 0.080), | ||
| Centre-based preschool for 2 y | 4 y | Regular chips consumption (vs. not) | 5–6 y | Multivariable probit regression models | AME = 0.024 (SE: 0.081), | ||
| Centre-based preschool for 2 y | 4 y | Infrequent vegetable consumption (vs. frequent) | 5–6 y | Multivariable probit regression models | AME = −0.113 (SE: 0.090), | ||
| Centre-based preschool for 2 y | 4 y | Infrequent fruit consumption (vs. frequent) | 5–6 y | Multivariable probit regression models | AME = −0.231 (SE: 0.093), | ||
| Head Start | 4 y | Low activity level | 5–6 y | Multivariable probit regression models | AME = 0.313 (SE: 0.142), | ||
| Head Start | 4 y | Screened low activity | 5–6 y | Multivariable probit regression models | AME = 0.128 (SE: 0.112), | ||
| Head Start | 4 y | Regular fast food consumption (vs. not) | 5–6 y | Multivariable probit regression models | AME = 0.050 (SE: 0.077), | ||
| Head Start | 4 y | Regular soda consumption (vs. not) | 5–6 y | Multivariable probit regression models | AME = −0.065 (SE: 0.081), | ||
| Head Start | 4 y | Regular candy consumption (vs. not) | 5–6 y | Multivariable probit regression models | AME = −0.108 (SE: 0.073), | ||
| Head Start | 4 y | Regular chips consumption (vs. not) | 5–6 y | Multivariable probit regression models | AME = 0.040 (SE: 0.074), | ||
| Head Start | 4 y | Infrequent vegetable consumption (vs. frequent) | 5–6 y | Multivariable probit regression models | AME = −0.067 (SE: 0.083), | ||
| Head Start | 4 y | Infrequent fruit consumption (vs. frequent) | 5–6 y | Multivariable probit regression models | AME = −0.266 (SE: 0.085), | ||
| Cairns & Harsh (2014) | All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Total sleep duration weekday | 5 y b | Group by assessment mixed model ANOVA | None reported | Group: Not significant |
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Nocturnal sleep duration weekday | 5 y b | Group by assessment mixed model ANOVA | Group: Not significant | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Sleep onset weekday | 5 y b | Group by assessment mixed model ANOVA | Group: F(1,32) = 5.8, | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Sleep onset time weekend | 5 y b | Group by assessment mixed model ANOVA | Group: Not reported | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Wake up time weekday | 5 y b | Group by assessment mixed model ANOVA | Group: F(1,32) = 14.9, | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Wake up time weekend | 5 y b | Group by assessment mixed model ANOVA | Group: Not reported | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Sleep efficiency weekday | 5 y b | Group by assessment mixed model ANOVA | Group: Not significant | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Nap duration weekday | 5 y b | Group by assessment mixed model ANOVA | Group: Not reported | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Nap duration weekend | 5 y b | Group by assessment mixed model ANOVA | Group: Not reported | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Number of weekdays with a nap | 5 y b | T-test (Summer vs. 2 weeks after start of kindergarten) | Group: Not reported | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Number of weekday naps | 5 y b | Group by assessment mixed model ANOVA | Group: Not significant | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Number of weekend naps | 5 y b | Group by assessment mixed model ANOVA | Group: Not significant | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Caregivers rating children as having less difficulty in going to bed | 5 y b | Group by assessment mixed model ANOVA | Group: Not reported | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Caregivers rating children as having less difficulty falling asleep | 5 y b | Group by assessment mixed model ANOVA | Group: Not reported | ||
| All day preschool/daycare (vs. primary/secondary caregiver) | 5 y a | Caregivers ratings of returning to wakefulness in the morning | 5 y b | Group by assessment mixed model ANOVA | Group: Not reported | ||
| Camara et al. (2015) | Childcare arrangement | 2–3 y | Processed, fast-foods at 2, 3, and 5 y dietary pattern | 2, 3, 5 y | Multivariable linear regression | Child’s age, gender, recruitment centre, season when the food frequency questionnaire was completed household disadvantage composite index, older sibling at home (2 y), maternal age at delivery, education level, and current/ past occupation, working time, and unemployed/student when child aged 2 y | At home, cared for by mother: Reference |
| Childcare arrangement | 2–3 y | Guidelines at 2, 3 and 5 y dietary pattern | 2, 3, 5 y | Multivariable linear regression | At home, cared for by mother: Reference | ||
| D’Onise et al. (2011) | Attended Kindergarten Union preschool (vs. not attended) | 2–5 y | PA level | Preschool mean: 45.3 y | Multinomial logistic regression | Age, gender, child socioeconomic position, adult height, educational attainment, and adult income | Sedentary: Reference |
| Lee et al. (2013) | Type of childcare arrangement on a regular basis—Head Start vs. not Head Start | 4 y | Frequency of having healthy eating patterns (times/week) | 5–6 y | Propensity score-weighted regressions | Child’s variables: (e.g., gender, ethnicity, multiple birth, prematurity, breastfeeding and number of siblings at 9 mo, pre-treatment outcomes at 2 y); | M = 2.21 (SE: 0.74), |
| Type of childcare arrangement on a regular basis—Head Start vs. not Head Start | 4 y | Frequency of having unhealthy eating patterns (times/week) | 5–6 y | Propensity score-weighted regressions | M = 0.63 (SE: 0.57), | ||
| Type of childcare arrangement on a regular basis—Head Start vs. Pre-Kindergarten | 4 y | Frequency of having healthy eating patterns (times/week) | 5–6 y | Propensity score-weighted regressions | M = 1.26 (SE: 1.33), | ||
| Type of childcare arrangement on a regular basis—Head Start vs. Pre-Kindergarten | 4 y | Frequency of having unhealthy eating patterns (times/week) | 5–6 y | Propensity score-weighted regressions | M = 0.36 (SE: 0.97), | ||
| Type of childcare arrangement on a regular basis—Head Start vs. Other centre-based | 4 y | Frequency of having healthy eating patterns (times/week) | 5–6 y | Propensity score-weighted regressions | M = 2.35 (SE: 1.14), | ||
| Type of childcare arrangement on a regular basis—Head Start vs. Other centre-based | 4 y | Frequency of having unhealthy eating patterns (times/week) | 5–6 y | Propensity score-weighted regressions | M = 0.80 (SE: 0.78), | ||
| Type of childcare arrangement on a regular basis—Head Start vs. Other non-parental | 4 y | Frequency of having healthy eating patterns (times/week) | 5–6 y | Propensity score-weighted regressions | M = 2.74 (SE: 1.32), | ||
| Type of childcare arrangement on a regular basis—Head Start vs. Other non-parental | 4 y | Frequency of having unhealthy eating patterns (times/week) | 5–6 y | Propensity score-weighted regressions | M = 0.77 (SE:0.98), | ||
| Type of childcare arrangement on a regular basis—Head Start vs. parental | 4 y | Frequency of having healthy eating patterns (times/week) | 5–6 y | Propensity score-weighted regressions | M = 2.07 (SE: 1.01), | ||
| Type of childcare arrangement on a regular basis—Head Start vs. parental | 4 y | Frequency of having unhealthy eating patterns (times/week) | 5–6 y | Propensity score-weighted regressions | M = 0.47 (SE: 0.77), | ||
| Levy et al. (2002) | Number of days in childcare between 0–6 mo of age | 6 weeks, 3 months, 6 months (referring to preceding time period) | Time until cessation of breastfeeding | 6 weeks, 3 months, 6 months | Cox proportional hazard regression | Pacifier use, digit sucking, maternal and paternal age and education, family income, breastfeeding plans, maternal smoking, infant’s gender, and infant antibiotic use. | No pacifier use, or digit sucking, or childcare: Reference |
| Lumeng et al. (2005) | Centre-based childcare attendance intensity (none vs. 15 h/week vs. ≥15 h/week) | 3–5 y | >4 h/day of TV viewing (yes vs. no) | 6–12 y | Turkey’s test | None | Not significant, |
| Lumeng et al. (2006) | Average number of hours in non-parental childcare | 24–36 months | TV viewing (<2 h/day vs. ≥2 h/day) | 36 months | None | Not significant, | |
| Pearce et al. (2012) | Overall childcare type | <4 to 9 months | Breastfeeding for ≥4 months | 9 months | Poisson regression | Mother’s ethnicity, parity, age at first live birth, and whether the mother returned to work before the infant was age 4 mo | Parent: Reference |
| Childcare type by intensity | <4 to 9 months | Breastfeeding for ≥4 months | 9 months | Poisson regression | Parent: Reference | ||
| Childcare type by National Statistics Socio-economic Classification | <4 to 9 months | Breastfeeding for ≥4 months | 9 months | Poisson regression | Routine and Manual: | ||
| Childcare type by Maternal Education | <4 to 9 months | Breastfeeding for ≥4 months | 9 months | Poisson regression | None–GCSE D–G: | ||
| Childcare type by Lone Parenthood | <4 to 9 months | Breastfeeding for ≥4 months | 9 months | Poisson regression | Lone parent: | ||
| Childcare type by Area Deprivation | <4 to 9 months | Breastfeeding for ≥4 months | 9 months | Poisson regression | 5 (Most deprived): | ||
| Sata et al. (2015) | Main daytime caregiver | 3 y | Between-meal eating before dinner | 6 y | Logistic regression models, stratified by gender | Baseline types of feeding, wake-up time, time of sleep, physical activity, playing outside, living with brothers or sisters, picky eating, and father’s employment. | Boys: |
| Main daytime caregiver | 3 y | Between-meal eating ≥3 times/day | 6 y | Logistic regression models, stratified by gender | Boys: | ||
| Main daytime caregiver | 3 y | Between-meal eating before bedtime ≥3 times/week | 6 y | Logistic regression models, stratified by gender | Boys: | ||
| Main daytime caregiver | 3 y | Between-meal eating before dinner | 12 y | Logistic regression models, stratified by gender | Boys: | ||
| Main daytime caregiver | 3 y | Between-meal eating ≥5 times/week | 12 y | Logistic regression models, stratified by gender | Boys: | ||
| Main daytime caregiver | 3 y | Between-meal eating before bedtime ≥3 times/week | 12 y | Logistic regression models, stratified by gender | Boys: | ||
| Main daytime caregiver | 3 y | Between-meal eating before dinner | 22 y | Logistic regression models, stratified by gender | Boys: | ||
| Main daytime caregiver | 3 y | Between-meal eating ≥5 times/week | 22 y | Logistic regression models, stratified by gender | Boys: | ||
| Main daytime caregiver | 3 y | Between-meal eating before bedtime ≥3 times/week | 22 y | Logistic regression models, stratified by gender | Boys: | ||
| Taylor et al. (2009) | Number of hours per week childcare attendance | 3, 4, 5 y | Total active time (minutes/day) | 3, 4, 5 y | Random coefficient regression | None reported | Not significant, |
| Number of hours per week childcare attendance | 3, 4, 5 y | Average accelerometer counts (counts/minute) | 3, 4, 5 y | Random coefficient regression | None reported | Not significant, | |
| Wasser et al. (2013) | Any non-maternal caregiver use | 6–18 months | Consuming any whole fruit | 6–18 months | Random-effects logistic regression | Maternal age, employment, depression, any maternal | None: Reference |
| Any non-maternal caregiver use | 6–18 months | Consuming any vegetable | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Any non-maternal caregiver use | 6–18 months | Consuming any juice | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Any non-maternal caregiver use | 6–18 months | Consuming any fried potatoes | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Any non-maternal caregiver use | 6–18 months | Consuming any desserts and sweets | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Any non-maternal caregiver use | 6–18 months | Consuming any sweetened beverages | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Any non-maternal caregiver use | 6–18 months | Consuming any salty snacks | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Type of non-maternal caregiver use | 6–18 months | Consuming any whole fruit | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Type of non-maternal caregiver use | 6–18 months | Consuming any vegetable | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Type of non-maternal caregiver use | 6–18 months | Consuming any juice | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Type of non-maternal caregiver use | 6–18 months | Consuming any fried potatoes | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Type of non-maternal caregiver use | 6–18 months | Consuming any desserts and sweets | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Type of non-maternal caregiver use | 6–18 months | Consuming any sweetened beverages | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Type of non-maternal caregiver use | 6–18 months | Consuming any salty snacks | 6–18 months | Random-effects logistic regression | None: Reference | ||
| Weile et al. (1990) | Attending daycare (vs. cared for at home) | 1–12 months | Changing from feeding categories 1/2 to categories 3/4/5 * | 1–12 months | Cox proportional | Other children in family and socioeconomic status | RR = 2.08 (95%CI: 1.43–3.01), |
| Attending daycare (vs. cared for at home) | 1–12 months | Changing from feeding categories 1/2/3 to categories 4/5 * | 1–12 months | Cox proportional | Other children in family and socioeconomic status | RR = 2.05 (95%CI:1.39–3.02), | |
| Attending daycare (vs. cared for at home) | 1–12 months | Changing from feeding categories 1/2/3/4 to category 5 * | 1–12 months | Cox proportional | Other children in family and socioeconomic status | RR = 2.50 (95%CI: 1.66–3.78), |
Legend: AME—average marginal effects; CI—confidence interval; h—hours; mo—months; y—years; OR—odds ratio; PA—physical activity; RR—relative risk; RRR—relative risk ratio; SD—standard deviation; SE—robust standard errors; TV—television; y—years. a 2–3 weeks before start of kindergarten; b 2 weeks, 1 month after start of kindergarten; * Categories: (1) 100% breast-fed, (2) breast-fed > formula-fed, (3) breast-fed = formula-fed, (4) breast-fed < formula-fed, and (5) 100% formula-fed. # Estimates and significance figures taken from text only, as article did not present tables and we could not obtain these from publishers or authors.
Results of the Nutrition Evidence Library Bias Assessment Tool risk of bias evaluation.
| NEL-BAT Question | Belfield & Kelly (2013) [ | Cairns & Harsh (2014) [ | D’Onise et al. (2011) [ | Lumeng et al. (2005) [ | Lumeng et al. (2006) [ | Taylor et al. (2009) [ | Camara et al. (2015) [ | Lee et al. (2013) [ | Levy et al. (2002) [ | Pearce et al. (2012) [ | Stata et al. (2015) [ | Wasser et al. (2013) [ | Weile et al. (1990) [ | Total Score by Question |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1.Were the inclusion/exclusion criteria similar across study groups? | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2. Was the strategy for recruiting or allocating participants similar across study groups? | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 5. Was there an attempt to balance the allocation between the study groups or match the study groups (e.g., through stratification, matching, propensity scores)? | 0 | 2 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 1 | 2 | 1 | 0 | 10 |
| 6. Was distribution of health status, demographics, and other critical confounding factors similar across study groups at baseline? If not, does the analysis control for baseline differences between groups? | 0 | 1 | 0 | 2 | 2 | 0 | 0 | 0 | 1 | 1 | 2 | 1 | 1 | 11 |
| 7. Did the investigators account for important variations in the execution of the study from the proposed protocol or research plan? | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| 8. Was adherence to the study protocol similar across study groups? | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 7 |
| 9. Did the investigators account for the impact of unintended/unplanned concurrent interventions or exposures that were differentially experienced by study groups and might bias results? | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 6 |
| 12. Were outcome assessors blinded to the intervention or exposure status of participants? | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 2 | 2 | 1 | 2 | 1 | 2 | 14 |
| 13. Were valid and reliable measures used consistently across all study groups to assess inclusion/exclusion criteria, interventions/exposures, outcomes, participant health benefits and harms, and confounding? | 1 | 0 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | 2 | 2 | 2 | 22 |
| 14. Was the length of follow-up similar across study groups? | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| 15. In cases of high or differential loss to follow-up, was the impact assessed (e.g., through sensitivity analysis or other adjustment method)? | 0 | 1 | 1 | 1 | 1 | 0 | 2 | 0 | 1 | 0 | 2 | 0 | 0 | 9 |
| 16. Were other sources of bias taken into account in the design and/or analysis of the study (e.g., through matching, stratification, interaction terms, multivariate analysis, or other statistical adjustment such as instrumental variables)? | 0 | 2 | 0 | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 |
| 17.Were the statistical methods used to assess the primary outcomes adequate? | 0 | 0 | 0 | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 |
|
| 1 | 7 | 6 | 12 | 9 | 8 | 8 | 6 | 9 | 6 | 12 | 7 | 6 |