Interventions to prevent obesity in children aged 5 to 11 years old.

BACKGROUND: Prevention of obesity in children is an international public health priority given the prevalence of the condition (and its significant impact on health, development and well-being). Interventions that aim to prevent obesity involve behavioural change strategies that promote healthy eating or 'activity' levels (physical activity, sedentary behaviour and/or sleep) or both, and work by reducing energy intake and/or increasing energy expenditure, respectively. There is uncertainty over which approaches are more effective and numerous new studies have been published over the last five years, since the previous version of this Cochrane review. OBJECTIVES: To assess the effects of interventions that aim to prevent obesity in children by modifying dietary intake or 'activity' levels, or a combination of both, on changes in BMI, zBMI score and serious adverse events. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was February 2023. SELECTION CRITERIA: Randomised controlled trials in children (mean age 5 years and above but less than 12 years), comparing diet or 'activity' interventions (or both) to prevent obesity with no intervention, usual care, or with another eligible intervention, in any setting. Studies had to measure outcomes at a minimum of 12 weeks post baseline. We excluded interventions designed primarily to improve sporting performance. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our outcomes were body mass index (BMI), zBMI score and serious adverse events, assessed at short- (12 weeks to < 9 months from baseline), medium- (9 months to < 15 months) and long-term (≥ 15 months) follow-up. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: This review includes 172 studies (189,707 participants); 149 studies (160,267 participants) were included in meta-analyses. One hundred forty-six studies were based in high-income countries. The main setting for intervention delivery was schools (111 studies), followed by the community (15 studies), the home (eight studies) and a clinical setting (seven studies); one intervention was conducted by telehealth and 31 studies were conducted in more than one setting. Eighty-six interventions were implemented for less than nine months; the shortest was conducted over one visit and the longest over four years. Non-industry funding was declared by 132 studies; 24 studies were funded in part or wholly by industry. Dietary interventions versus control Dietary interventions, compared with control, may have little to no effect on BMI at short-term follow-up (mean difference (MD) 0, 95% confidence interval (CI) -0.10 to 0.10; 5 studies, 2107 participants; low-certainty evidence) and at medium-term follow-up (MD -0.01, 95% CI -0.15 to 0.12; 9 studies, 6815 participants; low-certainty evidence) or zBMI at long-term follow-up (MD -0.05, 95% CI -0.10 to 0.01; 7 studies, 5285 participants; low-certainty evidence). Dietary interventions, compared with control, probably have little to no effect on BMI at long-term follow-up (MD -0.17, 95% CI -0.48 to 0.13; 2 studies, 945 participants; moderate-certainty evidence) and zBMI at short- or medium-term follow-up (MD -0.06, 95% CI -0.13 to 0.01; 8 studies, 3695 participants; MD -0.04, 95% CI -0.10 to 0.02; 9 studies, 7048 participants; moderate-certainty evidence). Five studies (1913 participants; very low-certainty evidence) reported data on serious adverse events: one reported serious adverse events (e.g. allergy, behavioural problems and abdominal discomfort) that may have occurred as a result of the intervention; four reported no effect. Activity interventions versus control Activity interventions, compared with control, may have little to no effect on BMI and zBMI at short-term or long-term follow-up (BMI short-term: MD -0.02, 95% CI -0.17 to 0.13; 14 studies, 4069 participants; zBMI short-term: MD -0.02, 95% CI -0.07 to 0.02; 6 studies, 3580 participants; low-certainty evidence; BMI long-term: MD -0.07, 95% CI -0.24 to 0.10; 8 studies, 8302 participants; zBMI long-term: MD -0.02, 95% CI -0.09 to 0.04; 6 studies, 6940 participants; low-certainty evidence). Activity interventions likely result in a slight reduction of BMI and zBMI at medium-term follow-up (BMI: MD -0.11, 95% CI -0.18 to -0.05; 16 studies, 21,286 participants; zBMI: MD -0.05, 95% CI -0.09 to -0.02; 13 studies, 20,600 participants; moderate-certainty evidence). Eleven studies (21,278 participants; low-certainty evidence) reported data on serious adverse events; one study reported two minor ankle sprains and one study reported the incident rate of adverse events (e.g. musculoskeletal injuries) that may have occurred as a result of the intervention; nine studies reported no effect. Dietary and activity interventions versus control Dietary and activity interventions, compared with control, may result in a slight reduction in BMI and zBMI at short-term follow-up (BMI: MD -0.11, 95% CI -0.21 to -0.01; 27 studies, 16,066 participants; zBMI: MD -0.03, 95% CI -0.06 to 0.00; 26 studies, 12,784 participants; low-certainty evidence) and likely result in a reduction of BMI and zBMI at medium-term follow-up (BMI: MD -0.11, 95% CI -0.21 to 0.00; 21 studies, 17,547 participants; zBMI: MD -0.05, 95% CI -0.07 to -0.02; 24 studies, 20,998 participants; moderate-certainty evidence). Dietary and activity interventions compared with control may result in little to no difference in BMI and zBMI at long-term follow-up (BMI: MD 0.03, 95% CI -0.11 to 0.16; 16 studies, 22,098 participants; zBMI: MD -0.02, 95% CI -0.06 to 0.01; 22 studies, 23,594 participants; low-certainty evidence). Nineteen studies (27,882 participants; low-certainty evidence) reported data on serious adverse events: four studies reported occurrence of serious adverse events (e.g. injuries, low levels of extreme dieting behaviour); 15 studies reported no effect. Heterogeneity was apparent in the results for all outcomes at the three follow-up times, which could not be explained by the main setting of the interventions (school, home, school and home, other), country income status (high-income versus non-high-income), participants' socioeconomic status (low versus mixed) and duration of the intervention. Most studies excluded children with a mental or physical disability. AUTHORS' CONCLUSIONS: The body of evidence in this review demonstrates that a range of school-based 'activity' interventions, alone or in combination with dietary interventions, may have a modest beneficial effect on obesity in childhood at short- and medium-term, but not at long-term follow-up. Dietary interventions alone may result in little to no difference. Limited evidence of low quality was identified on the effect of dietary and/or activity interventions on severe adverse events and health inequalities; exploratory analyses of these data suggest no meaningful impact. We identified a dearth of evidence for home and community-based settings (e.g. delivered through local youth groups), for children living with disabilities and indicators of health inequities.

Interventions to prevent obesity in children aged 12 to 18 years old.

BACKGROUND: Prevention of obesity in adolescents is an international public health priority. The prevalence of overweight and obesity is over 25% in North and South America, Australia, most of Europe, and the Gulf region. Interventions that aim to prevent obesity involve strategies that promote healthy diets or 'activity' levels (physical activity, sedentary behaviour and/or sleep) or both, and work by reducing energy intake and/or increasing energy expenditure, respectively. There is uncertainty over which approaches are more effective, and numerous new studies have been published over the last five years since the previous version of this Cochrane Review. OBJECTIVES: To assess the effects of interventions that aim to prevent obesity in adolescents by modifying dietary intake or 'activity' levels, or a combination of both, on changes in BMI, zBMI score and serious adverse events. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was February 2023. SELECTION CRITERIA: Randomised controlled trials in adolescents (mean age 12 years and above but less than 19 years), comparing diet or 'activity' interventions (or both) to prevent obesity with no intervention, usual care, or with another eligible intervention, in any setting. Studies had to measure outcomes at a minimum of 12 weeks post baseline. We excluded interventions designed primarily to improve sporting performance. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our outcomes were BMI, zBMI score and serious adverse events, assessed at short- (12 weeks to < 9 months from baseline), medium- (9 months to < 15 months) and long-term (≥ 15 months) follow-up. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: This review includes 74 studies (83,407 participants); 54 studies (46,358 participants) were included in meta-analyses. Sixty studies were based in high-income countries. The main setting for intervention delivery was schools (57 studies), followed by home (nine studies), the community (five studies) and a primary care setting (three studies). Fifty-one interventions were implemented for less than nine months; the shortest was conducted over one visit and the longest over 28 months. Sixty-two studies declared non-industry funding; five were funded in part by industry. Dietary interventions versus control The evidence is very uncertain about the effects of dietary interventions on body mass index (BMI) at short-term follow-up (mean difference (MD) -0.18, 95% confidence interval (CI) -0.41 to 0.06; 3 studies, 605 participants), medium-term follow-up (MD -0.65, 95% CI -1.18 to -0.11; 3 studies, 900 participants), and standardised BMI (zBMI) at long-term follow-up (MD -0.14, 95% CI -0.38 to 0.10; 2 studies, 1089 participants); all very low-certainty evidence. Compared with control, dietary interventions may have little to no effect on BMI at long-term follow-up (MD -0.30, 95% CI -1.67 to 1.07; 1 study, 44 participants); zBMI at short-term (MD -0.06, 95% CI -0.12 to 0.01; 5 studies, 3154 participants); and zBMI at medium-term (MD 0.02, 95% CI -0.17 to 0.21; 1 study, 112 participants) follow-up; all low-certainty evidence. Dietary interventions may have little to no effect on serious adverse events (two studies, 377 participants; low-certainty evidence). Activity interventions versus control Compared with control, activity interventions do not reduce BMI at short-term follow-up (MD -0.64, 95% CI -1.86 to 0.58; 6 studies, 1780 participants; low-certainty evidence) and probably do not reduce zBMI at medium- (MD 0, 95% CI -0.04 to 0.05; 6 studies, 5335 participants) or long-term (MD -0.05, 95% CI -0.12 to 0.02; 1 study, 985 participants) follow-up; both moderate-certainty evidence. Activity interventions do not reduce zBMI at short-term follow-up (MD 0.02, 95% CI -0.01 to 0.05; 7 studies, 4718 participants; high-certainty evidence), but may reduce BMI slightly at medium-term (MD -0.32, 95% CI -0.53 to -0.11; 3 studies, 2143 participants) and long-term (MD -0.28, 95% CI -0.51 to -0.05; 1 study, 985 participants) follow-up; both low-certainty evidence. Seven studies (5428 participants; low-certainty evidence) reported data on serious adverse events: two reported injuries relating to the exercise component of the intervention and five reported no effect of intervention on reported serious adverse events. Dietary and activity interventions versus control Dietary and activity interventions, compared with control, do not reduce BMI at short-term follow-up (MD 0.03, 95% CI -0.07 to 0.13; 11 studies, 3429 participants; high-certainty evidence), and probably do not reduce BMI at medium-term (MD 0.01, 95% CI -0.09 to 0.11; 8 studies, 5612 participants; moderate-certainty evidence) or long-term (MD 0.06, 95% CI -0.04 to 0.16; 6 studies, 8736 participants; moderate-certainty evidence) follow-up. They may have little to no effect on zBMI in the short term, but the evidence is very uncertain (MD -0.09, 95% CI -0.2 to 0.02; 3 studies, 515 participants; very low-certainty evidence), and they may not reduce zBMI at medium-term (MD -0.05, 95% CI -0.1 to 0.01; 6 studies, 3511 participants; low-certainty evidence) or long-term (MD -0.02, 95% CI -0.05 to 0.01; 7 studies, 8430 participants; low-certainty evidence) follow-up. Four studies (2394 participants) reported data on serious adverse events (very low-certainty evidence): one reported an increase in weight concern in a few adolescents and three reported no effect. AUTHORS' CONCLUSIONS: The evidence demonstrates that dietary interventions may have little to no effect on obesity in adolescents. There is low-certainty evidence that activity interventions may have a small beneficial effect on BMI at medium- and long-term follow-up. Diet plus activity interventions may result in little to no difference. Importantly, this updated review also suggests that interventions to prevent obesity in this age group may result in little to no difference in serious adverse effects. Limitations of the evidence include inconsistent results across studies, lack of methodological rigour in some studies and small sample sizes. Further research is justified to investigate the effects of diet and activity interventions to prevent childhood obesity in community settings, and in young people with disabilities, since very few ongoing studies are likely to address these. Further randomised trials to address the remaining uncertainty about the effects of diet, activity interventions, or both, to prevent childhood obesity in schools (ideally with zBMI as the measured outcome) would need to have larger samples.

Common challenges and suggestions for risk of bias tool development: a systematic review of methodological studies.

OBJECTIVES: To review the findings of studies that have evaluated the design and/or usability of key risk of bias (RoB) tools for the assessment of RoB in primary studies, as categorized by the Library of Assessment Tools and InsTruments Used to assess Data validity in Evidence Synthesis Network (a searchable library of RoB tools for evidence synthesis): Prediction model Risk Of Bias ASessment Tool (PROBAST) , Risk of Bias-2 (RoB2), Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I), Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2), Quality Assessment of Diagnostic Accuracy Studies-Comparative (QUADAS-C), Quality Assessment of Prognostic Accuracy Studies (QUAPAS), Risk Of Bias in Non-randomised Studies of Exposures (ROBINS-E), and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) RoB checklist. STUDY DESIGN AND SETTING: Systematic review of methodological studies. We conducted a forward citation search from the primary report of each tool, to identify primary studies that aimed to evaluate the design and/or usability of the tool. Two reviewers assessed studies for inclusion. We extracted tool features into Microsoft Word and used NVivo for document analysis, comprising a mix of deductive and inductive approaches. We summarized findings within each tool and explored common findings across tools. RESULTS: We identified 13 tool evaluations meeting our inclusion criteria: PROBAST (3), RoB2 (3), ROBINS-I (4), and QUADAS-2 (3). We identified no evaluations for the other tools. Evaluations varied in clinical topic area, methodology, approach to bias assessment, and tool user background. Some had limitations affecting generalizability. We identified common findings across tools for 6/14 themes: (1) challenging items (eg, RoB2/ROBINS-I "deviations from intended interventions" domain), (2) overall RoB judgment (concerns with overall risk calculation in PROBAST/ROBINS-I), (3) tool usability (concerns about complexity), (4) time to complete tool (varying demands on time, eg, depending on number of outcomes assessed), (5) user agreement (varied across tools), and (6) recommendations for future use (eg, piloting) and development (add intermediate domain answer to QUADAS-2/PROBAST; provide clearer guidance for all tools). Of the other eight themes, seven only had findings for the QUADAS-2 tool, limiting comparison across tools, and one ("reorganization of questions") had no findings. CONCLUSION: Evaluations of key RoB tools have posited common challenges and recommendations for tool use and development. These findings may be helpful to people who use or develop RoB tools. Guidance is necessary to support the design and implementation of future RoB tool evaluations.