BackgroundImplementing evidence-based recommendations for treating pediatric overweight and obesity is challenging in low-resource settings. We conducted a randomized controlled trial to evaluate the effects of implementing the American Academy of Pediatrics overweight/obesity recommendations using a Standard Care approach alone or with the addition of an enhanced program in a safety-net pediatric primary care setting (located in Bronx, New York, United States).MethodsIn a 12-month trial, families of children (age 7–12 years; body mass index ≥85th American percentile for age and sex; 74% self-identified as Hispanic/Latino; n = 360) were randomly assigned to receive Standard Care Alone or Standard Care + Enhanced Program. An English/Spanish bilingual staff provided the Standard Care Alone consisting of quarterly semi-structured pediatrician visits targeting family-based behavioral changes. The Standard Care + Enhanced Program was enriched with eight Skill-Building Core and monthly Post-Core Support sessions.ResultsThe mean body mass index Z-score declined in both arms (P < 0.01) with no significant difference between the Standard Care Alone (0.12 kg [SE: 0.03]) and Standard Care + Enhanced Program (0.15 kg [SE: 0.03]) arm (P = 0.15). Compared to the Standard Care Alone, the Standard Care + Enhanced Program resulted in significantly greater improvements in total cholesterol (P = 0.05), low-density lipoprotein cholesterol (P = 0.04), aspartate aminotransferase (P = 0.02), and alanine transaminase (P = 0.03) concentrations.ConclusionsSafety-net primary care settings can provide efficacious pediatric weight management services. Targeted family-based behavioral counseling helps overweight/obese children achieve a modest body mass index Z-score improvement. A more intensive lifestyle intervention program may improve some metabolic parameters.Trial registrationClinicalTrials.gov Identifier: NCT00851201. Registered 23 February 2009.Electronic supplementary materialThe online version of this article (10.1186/s12966-017-0639-z) contains supplementary material, which is available to authorized users.
Objective To evaluate whether clustering effects, often quantified by the intracluster correlation coefficient (ICC), were appropriately accounted for in design and analysis of school-based trials. Methods We searched PubMed and extracted variables concerning study characteristics, power analysis, ICC use for power analysis, applied statistical models, and the report of the ICC estimated from the observed data. Results N=263 papers were identified, and N=121 papers were included for evaluation. Overall, only a minority (21.5%) of studies incorporated ICC values for power analysis, fewer studies (8.3%) reported the estimated ICC, and 68.6% of studies applied appropriate multilevel models. A greater proportion of studies applied the appropriate models during the past five years (2013–2017) compared to the prior years (74.1% versus 63.5%, p=0.176). Significantly associated with application of appropriate models were a larger number of schools (p=0.030), a larger sample size (p=0.002), longer follow-up (p=0.014), and randomization at a cluster level (p < 0.001) and so were studies that incorporated the ICC into power analysis (p=0.016) and reported the estimated ICC (p=0.030). Conclusion Although application of appropriate models has increased over the years, consideration of clustering effects in power analysis has been inadequate, as has report of estimated ICC. To increase rigor, future school-based trials should address these issues at both the design and analysis stages.
Background: School health curricula should help students choose health goals related to the Dietary Guidelines (DG) recommendations addressing obesity. We aimed to identify characteristics associated with choice of DG recommendation items. Methods: In 12 HealthCorps affiliated high schools, students completed a 19item web-based questionnaire that provided a personalized health-behavior feedback report to guide setting SMART (Specific, Measurable, Action-oriented, Realistic, Time-bound) goals. We examined if gender, weight-status, and personalized feedback report messages were related to student-selected SMART Goals. Results: The most frequent SMART Goals focused on breakfast (22.4%), physical activity (21.1%), and sugary beverages (20.4%). Students were more likely to choose a SMART goal related to breakfast, sugary beverages, fruit/vegetable intake or physical activity if their feedback report suggested that health behavior was problematic (p < 0.0001). Males were more likely than females to set sugary beverage goals (p < 0.05). Females tended to be more likely than males to set breakfast goals (p = 0.051). Students, who had obesity, were more likely than normal weight students to set physical activity goals (p < 0.05). Conclusion: SMART goals choice was associated with gender and weight status. SMART goal planning with a web-based questionnaire and personalized feedback report appears to help students develop goals related to the Dietary Guidelines recommendations.
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