Childhood obesity prevention trials: A systematic review and meta-analysis on trial design and the impact of type 1 error.

Effect sizes from previously reported trials are often used to determine the meaningful change in weight in childhood obesity prevention interventions because information on clinically meaningful differences is lacking. Estimates from previous trials may be influenced by statistical significance; therefore, it is important that they have a low risk of type 1 error. A systematic review and meta-analysis were conducted to report on the design of child obesity prevention randomized controlled trials and effectiveness according to risk of type 1 error. Eighty-four randomized controlled trials were identified. A large range of assumptions were applied in the sample size calculations. The most common primary outcome was BMI, with detectable effect size differences used in sample size calculations ranging from 0.25 kg/m2 (followed up at 2 years) to 1.1 kg/m2 (at 9 months) and BMI z-score ranging from 0.1 (at 4 years) to 0.67 (at 3 years). There was no consistent relationship between low risk of type 1 error and reports of higher or lower effectiveness. Further clarity of the size of a meaningful difference in weight in childhood obesity prevention trials is required to support evaluation design and decision-making for intervention and policy. Type 1 error risk does not appear to impact effect sizes in a consistent direction.

Design of a dual randomized trial in a type 2 hybrid effectiveness-implementation study.

BACKGROUND: Dual randomized controlled trials (DRCT) are type 2 hybrid studies that include two randomized trials: one testing implementation strategies and one testing an intervention. We argue that this study design offers efficiency by providing rigorous investigation of both implementation and intervention in one study and has potential to accelerate generation of the evidence needed to translate interventions that work into real-world practice. Nevertheless, studies using this design are rare in the literature. MAIN TEXT: We construct a paradigm that breaks down the components of the DRCT and provide a step-by-step explanation of features of the design and recommendations for use. A clear distinction is made between the dual strands that test the implementation versus the intervention, and a minimum of three randomized arms is advocated. We suggest an active treatment arm that includes both the implementation strategy and intervention that are hypothesized to be superior. We suggest two comparison/control arms: one to test the implementation strategy and the second to test the intervention. Further, we recommend selection criteria for the two control arms that place emphasis on maximizing the utility of the study design to advance public health practice. CONCLUSIONS: On the surface, the design of a DRCT can appear simple, but actual application is complex. We believe it is that complexity that has limited its use in the literature. We hope that this paper will give both implementation scientists and trialists who are not familiar with implementation science a better understanding of the DRCT design and encouragement to use it.

Diversity of plant DNA in stool is linked to dietary quality, age, and household income.

Eating a varied diet is a central tenet of good nutrition. Here, we develop a molecular tool to quantify human dietary plant diversity by applying DNA metabarcoding with the chloroplast trnL-P6 marker to 1,029 fecal samples from 324 participants across two interventional feeding studies and three observational cohorts. The number of plant taxa per sample (plant metabarcoding richness or pMR) correlated with recorded intakes in interventional diets and with indices calculated from a food frequency questionnaire in typical diets (ρ = 0.40 to 0.63). In adolescents unable to collect validated dietary survey data, trnL metabarcoding detected 111 plant taxa, with 86 consumed by more than one individual and four (wheat, chocolate, corn, and potato family) consumed by >70% of individuals. Adolescent pMR was associated with age and household income, replicating prior epidemiologic findings. Overall, trnL metabarcoding promises an objective and accurate measure of the number and types of plants consumed that is applicable to diverse human populations.

Implementation Research at NHLBI: Methodological and Design Challenges and Lessons Learned from the DECIPHeR Initiative.

NHLBI funded seven projects as part of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Initiative. They were expected to collaborate with community partners to (1) employ validated theoretical or conceptual implementation research frameworks, (2) include implementation research study designs, (3) include implementation measures as primary outcomes, and (4) inform our understanding of mediators and mechanisms of action of the implementation strategy. Several projects focused on late-stage implementation strategies that optimally and sustainably delivered two or more evidence-based multilevel interventions to reduce or eliminate cardiovascular and/or pulmonary health disparities and to improve population health in high-burden communities. Projects that were successful in the three-year planning phase transitioned to a 4-year execution phase. NHLBI formed a Technical Assistance Workgroup during the planning phase to help awardees refine study aims, strengthen research designs, detail analytic plans, and to use valid sample size methods. This paper highlights methodological and study design challenges encountered during this process. Important lessons learned included (1) the need for greater emphasis on implementation outcomes, (2) the need to clearly distinguish between intervention and implementation strategies in the protocol, (3) the need to address clustering due to randomization of groups or clusters, (4) the need to address the cross-classification that results when intervention agents work across multiple units of randomization in the same arm, (5) the need to accommodate time-varying intervention effects in stepped-wedge designs, and (6) the need for data-based estimates of the parameters required for sample size estimation.

Efficacy of a Commercial Weight Management Program Compared With a Do-It-Yourself Approach: A Randomized Clinical Trial.

Importance: Given the prevalence of obesity, accessible and effective treatment options are needed to manage obesity and its comorbid conditions. Commercial weight management programs are a potential solution to the lack of available treatment, providing greater access at lower cost than clinic-based approaches, but few commercial programs have been rigorously evaluated. Objective: To compare the differences in weight change between individuals randomly assigned to a commercial weight management program and those randomly assigned to a do-it-yourself (DIY) approach. Design, Setting, and Participants: This 1-year, randomized clinical trial conducted in the United States, Canada, and United Kingdom between June 19, 2018, and November 30, 2019, enrolled 373 adults aged 18 to 75 years with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 25 to 45. Assessors were blinded to treatment conditions. Interventions: A widely available commercial weight management program that included reduced requirements for dietary self-monitoring and recommendations for a variety of DIY approaches to weight loss. Main Outcomes and Measures: The primary outcomes were the difference in weight change between the 2 groups at 3 and 12 months. The a priori hypothesis was that the commercial program would result in greater weight loss than the DIY approach at 3 and 12 months. Analyses were performed on an intention-to-treat basis. Results: The study include 373 participants (272 women [72.9%]; mean [SD] BMI, 33.8 [5.2]; 77 [20.6%] aged 18-34 years, 74 [19.8%] aged 35-43 years, 82 [22.0%] aged 44-52 years, and 140 [37.5%] aged 53-75 years). At 12 months, retention rates were 88.8% (166 of 187) for the commercial weight management program group and 95.7% (178 of 186) for the DIY group. At 3 months, participants in the commercial program had a mean (SD) weight loss of -3.8 (4.1) kg vs -1.8 (3.7) kg among those in the DIY group. At 12 months, participants in the commercial program had a mean (SD) weight loss of -4.4 (7.3) kg vs -1.7 (7.3) kg among those in the DIY group. The mean difference between groups was -2.0 kg (97.5% CI, -2.9 to -1.1 kg) at 3 months (P < .001) and -2.6 kg (97.5% CI, -4.3 to -0.8 kg) at 12 months (P < .001). A greater percentage of participants in the commercial program group than participants in the DIY group achieved loss of 5% of body weight at both 3 months (40.7% [72 of 177] vs 18.6% [34 of 183]) and 12 months (42.8% [71 of 166] vs 24.7% [44 of 178]). Conclusions and Relevance: Adults randomly assigned to a commercial weight management program with reduced requirements for dietary self-monitoring lost more weight and were more likely to achieve weight loss of 5% at 3 and 12 months than adults following a DIY approach. This study contributes data on the efficacy of commercial weight management programs and DIY weight management approaches. Trial Registration: ClinicalTrials.gov Identifier: NCT03571893.

The National Heart Lung and Blood Institute Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Alliance.

OBJECTIVE: To describe the National Heart Lung and Blood Institute (NHLBI) sponsored Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease (DECIPHeR) Alliance to support late-stage implementation research aimed at reducing disparities in communities with high burdens of cardiovascular and/or pulmonary disease. STUDY SETTING: NHBLI funded seven DECIPHeR studies and a Coordinating Center. Projects target high-risk diverse populations including racial and ethnic minorities, urban, rural, and low-income communities, disadvantaged children, and persons with serious mental illness. Two projects address multiple cardiovascular risk factors, three focus on hypertension, one on tobacco use, and one on pediatric asthma. STUDY DESIGN: The initial phase supports planning activities for sustainable uptake of evidence-based interventions in targeted communities. The second phase tests late-stage evidence-based implementation strategies. DATA COLLECTION/EXTRACTION METHODS: Not applicable. PRINCIPAL FINDINGS: We provide an overview of the DECIPHeR Alliance and individual study designs, populations, and settings, implementation strategies, interventions, and outcomes. We describe the Alliance's organizational structure, designed to promote cross-center partnership and collaboration. CONCLUSIONS: The DECIPHeR Alliance represents an ambitious national effort to develop sustainable implementation of interventions to achieve cardiovascular and pulmonary health equity.

Frequency and Geographic Distribution of Borrelia miyamotoi, Borrelia burgdorferi, and Babesia microti Infections in New England Residents.

BACKGROUND: Borrelia miyamotoi is a relapsing fever spirochete that relatively recently has been reported to infect humans. It causes an acute undifferentiated febrile illness that can include meningoencephalitis and relapsing fever. Like Borrelia burgdorferi, it is transmitted by Ixodes scapularis ticks in the northeastern United States and by Ixodes pacificus ticks in the western United States. Despite reports of clinical cases from North America, Europe, and Asia, the prevalence, geographic range, and pattern of expansion of human B. miyamotoi infection are uncertain. To better understand these characteristics of B. miyamotoi in relation to other tickborne infections, we carried out a cross-sectional seroprevalence study across New England that surveyed B. miyamotoi, B. burgdorferi, and Babesia microti infections. METHODS: We measured specific antibodies against B. miyamotoi, B. burgdorferi, and B. microti among individuals living in 5 New England states in 2018. RESULTS: Analysis of 1153 serum samples collected at 11 catchment sites showed that the average seroprevalence for B. miyamotoi was 2.8% (range, 0.6%-5.2%), which was less than that of B. burgdorferi (11.0%; range, 6.8%-15.6%) and B. microti (10.0%; range, 6.5%-13.6%). Antibody screening within county residence in New England showed varying levels of seroprevalence for these pathogens but did not reveal a vectoral geographical pattern of distribution. CONCLUSIONS: Human infections caused by B. miyamotoi, B. burgdorferi, and B. microti are widespread with varying prevalence throughout New England.

A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial.

BACKGROUND: Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementation optimisation intervention. This intervention aimed to promote parental enrolment and attendance at HENRY (Health Exercise Nutrition for the Really Young), a UK community obesity prevention programme, by changing behaviours of children's centre and local authority stakeholders. METHODS: We evaluated the effectiveness of the implementation optimisation intervention on HENRY programme enrolment and attendance over a 12-month implementation period in a cluster randomised controlled trial. We randomised 20 local government authorities (with 126 children's centres) to HENRY plus the implementation optimisation intervention or to HENRY alone. Primary outcomes were (1) the proportion of centres enrolling at least eight parents per programme and (2) the proportion of centres with a minimum of 75% of parents attending at least five of eight sessions per programme. Trial analyses adjusted for stratification factors (pre-randomisation implementation of HENRY, local authority size, deprivation) and allowed for cluster design. A parallel mixed-methods process evaluation used qualitative interviews and routine monitoring to explain trial results. RESULTS: Neither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference - 1.2%; 95% CI - 19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95% CI - 15.7%, 18.1%). Unexpectedly, the trial coincided with substantial national service restructuring, including centre closures and reduced funds. Some commissioning and management teams stopped or reduced delivery of both HENRY and the implementation optimisation intervention due to competing demands. Thus, at follow-up, HENRY programmes were delivered to approximately half the number of parents compared to baseline (n = 433 vs. 881). CONCLUSIONS: During a period in which services were reduced by external policies, this first definitive trial found no evidence of effectiveness for an implementation optimisation intervention promoting parent enrolment to and attendance at an obesity prevention programme. TRIAL REGISTRATION: ClinicalTrials.gov NCT02675699 . Registered on 4 February 2016.

A community-based, multi-level, multi-setting, multi-component intervention to reduce weight gain among low socioeconomic status Latinx children with overweight or obesity: The Stanford GOALS randomised controlled trial.

BACKGROUND: There are few long-term studies of interventions to reduce in low socioeconomic status children with overweight or obesity. The Stanford GOALS trial evaluated a 3-year, community-based, multi-level, multi-setting, multi-component (MMM) systems intervention, to reduce weight gain among low socioeconomic status, Latinx children with overweight or obesity. METHODS: We did a two-arm, parallel group, randomised, open-label, active placebo-controlled trial with masked assessment over 3 years. Families from low-income, primarily Latinx communities in Northern California, CA, USA, with 7-11-year-old children with overweight or obesity were randomly assigned to a MMM intervention or a Health Education (HE) comparison intervention. The MMM intervention included home environment changes and behavioural counselling, community after school team sports, and reports to primary health-care providers. The primary outcome was child BMI trajectory over three years. Secondary outcomes included one- and two-year changes in BMI. This trial is registered with ClinicalTrials.govNCT01642836. FINDINGS: Between July 13, 2012, and Oct 3, 2013, 241 families were recruited and randomly assigned to MMM (n=120) or HE (n=121). Children's mean age was 9·5 (SD 1·4) years, 134 (56%) were female and 107 (44%) were male, and 236 (98%) were Latinx. 238 (99%) children participated in year 1, 233 (97%) in year 2, and 227 (94%) in year 3 of follow-up assessments. In intention-to-treat analysis, over 3 years, the difference between intervention groups in BMI trajectory was not significant (mean adjusted difference -0·25 [95% CI -0·90 to 0·40] kg/m2; Cohen's d=0.10; p=0·45). Children in the MMM intervention group gained less BMI over 1 year than did children in the HE intervention group (-0·73 [-1·07 to -0·39] kg/m2, d=0.55); the same was true over 2 years (-0·63 [-1·13 to -0·14] kg/m2; d =0.33). No differential adverse events were observed. INTERPRETATION: The MMM intervention did not reduce BMI gain versus HE over 3 years but the effects over 1 and 2 years in this rigorous trial show the promise of this systems intervention approach for reducing weight gain and cardiometabolic risk factors in low socioeconomic status communities. FUNDING: US National Institutes of Health.

Contamination within trials of community-based public health interventions: lessons from the HENRY feasibility study.

INTRODUCTION: Contamination occurs when participants allocated to trial control arms receive elements of the active intervention. Randomisation at cluster level, rather than individual level, may reduce or eliminate contamination, avoiding the dilution of intervention effectiveness that it may cause. However, cluster randomisation can result in selection bias and may not be feasible to deliver. We explored the extent of contamination in a qualitative study nested within a feasibility study of HENRY (Health, Exercise and Nutrition for the Really Young); a UK community-based child obesity prevention programme. We aimed to determine the nature and impact of contamination to inform a larger planned trial and other trials in community based public health settings. METHOD: We invited participants to take part in the nested qualitative study who were already involved in the HENRY feasibility study. Semi-structured interviews/focus groups were conducted with children's centre managers (n=7), children's centre staff (n=15), and parents (n=29). Data were transcribed and analysed using an integrative approach. First, deductively organised using a framework guided by the topic guide and then organised using inductive thematic analysis. RESULTS: Potential for contamination between treatment arms was recognised by all stakeholder groups. Staff within the intervention centres presented the greatest risk of contamination, predominantly because they were often asked to work in other children centre's (including control group centres). 'Sharing of best practice' by staff was reported to be a common and desirable phenomenon within community based settings. Parental sharing of HENRY messages was reported inconsistently; though some parents indicated a high degree of knowledge transfer within their immediate circles. CONCLUSIONS: The extent of contamination identified has influenced the design of a future effectiveness trial of HENRY which will be clustered at the centre level (with geographically distinct clusters). The common practice of knowledge sharing amongst community teams means that this clustering approach is also likely to be most suitable for other trials based within these settings. We provide recommendations (e.g. cluster randomisation, training intervention facilitators on implications of contamination) to help reduce the impact of contamination in public health intervention trials with or without clustering, whilst enabling transfer of knowledge where appropriate. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017.

Identifying Key Determinants of Childhood Obesity: A Narrative Review of Machine Learning Studies.

Machine learning is a class of algorithms able to handle a large number of predictors with potentially nonlinear relationships. By applying machine learning to obesity, researchers can examine how risk factors across multiple settings (e.g., school and home) interact to best predict childhood obesity risk. In this narrative review, we provide an overview of studies that have applied machine learning to predict childhood obesity using a combination of sociodemographic and behavioral risk factors. The objective is to summarize the key determinants of obesity identified in existing machine learning studies and highlight opportunities for future machine learning applications in the field. Of 15 peer-reviewed studies, approximately half examined early childhood (0-24 months of age) determinants. These studies identified child's weight history (e.g., history of overweight/obesity or large increases in weight-related measures between birth and 24 months of age) and parental overweight/obesity (current or prior) as key risk factors, whereas the remaining studies indicated that social factors and physical inactivity were important in middle childhood and late childhood/adolescence. Across age groups, findings suggested that race/ethnic-specific models may be needed to accurately predict obesity from middle childhood onward. Future studies should consider using existing large data sets to take advantage of the benefits of machine learning and should collect a wider range of novel risk factors (e.g., psychosocial and sociocultural determinants of health) to better predict childhood obesity. Ultimately, such research can aid in the development of effective obesity prevention interventions, particularly ones that address the disproportionate burden of obesity experienced by racial/ethnic minorities.

Obesogenic home food availability, diet, and BMI in Pakistani and White toddlers.

Individuals of South Asian ethnicity have an increased risk for obesity and related diseases. Foods available in the home during the first 1000 days (conception to 24 months old) are an important determinant of diet, yet no study has examined the association of early-life home food availability (HFA) with later diet and obesity risk in South Asian households. We examined whether obesogenic HFA at 18 months of age is associated with dietary intake and body mass index (BMI) at 36 months of age in low-income Pakistani and White households in the United Kingdom. In this prospective birth cohort study (Born in Bradford 1000), follow-up assessments occurred at 18 (n = 1032) and 36 (n = 986) months of age. Variety and quantity of snack foods and sugar-sweetened beverages (SSBs) in the home and consumed were measured using the HFA Inventory Checklist and food frequency questionnaires, respectively. BMI was calculated using measured length/height and weight. Multinomial logistic regression models examined associations between HFA and tertiles of dietary intake, and multivariable linear regression models assessed associations between HFA and BMI. Pakistani households had a greater variety and quantity of snack foods and SSBs available compared with White households. Variety and quantity of snack foods and SSBs in the home at 18 months were positively associated with children's intake of these items at 36 months, but associations between HFA and BMI were null. Reducing obesogenic HFA during the first 1000 days may promote the development of more healthful diets, though this may not be associated with lower obesity risk during toddlerhood.

The association of Step-based metrics and adiposity in the Hispanic community Health Study/Study of Latinos.

OBJECTIVE: Examine cross-sectional and longitudinal associations of accelerometer measured step volume (steps/day) and cadence with adiposity and six-year changes in adiposity in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). METHODS: HCHS/SOL's target population was 60% female with a mean age of 41 years. Cross-sectional (n = 12,353) and longitudinal analyses (n = 9,077) leveraged adjusted complex survey regression models to examine associations between steps/day, and cadence with weight (kg), waist circumference (cm) and body mass index (kg/m2). Effect measure modification by covariates was examined. RESULTS: Lower steps/day and intensity was associated with higher adiposity at baseline. Compared to those in the highest quartile of steps/day those in the lowest quartile have 1.42 95% CI (1.19, 1.70) times the odds of obesity. Compared to those in the highest categories of cadence step-based metrics, those in the lowest categories had a 1.62 95% CI (1.36, 1.93), 2.12 95% CI (1.63, 2.75) and 1.41 95% CI (1.16, 1.70) odds of obesity for peak 30-minute cadence, brisk walking and faster ambulation and bouts of purposeful steps and faster ambulation, respectively. Compared to those with the highest stepping cadences, those with the slowest peak 30-minute cadence and fewest minutes in bouts of purposeful steps and faster ambulation had 0.72 95% CI (0.57, 0.89) and 0.82 95% CI (0.60, 1.14) times the odds of gaining weight, respectively. CONCLUSION: Inverse cross-sectional relationships were found for steps/day and cadence and adiposity. Over a six-year period, higher step intensity but not volume was associated with higher odds of gaining weight.

Applying the Behavior Change Technique Taxonomy to Four Multicomponent Childhood Obesity Interventions.

Applying the Behavior Change Technique Taxonomy has the potential to facilitate identification of effective childhood obesity intervention components. This article evaluates the feasibility of coding Childhood Obesity Prevention and Treatment Consortium interventions and compares reliability between external taxonomy-familiar coders and internal intervention-familiar coders. After training, coder pairs independently coded prespecified portions of intervention materials. An adjudication process was used to explore coding discrepancies. Reliability between internal and external coders was moderate (prevalence and bias-adjusted kappa .38 to .55). Reliability for specific target behaviors varied with substantial agreement for physical activity (.63 to .76) and moderate for dietary intake (.44 to .63). Applying the taxonomy to these interventions was feasible, but agreement was modest. Coding discrepancies highlight the importance of refining coding to capture the complexities of childhood obesity interventions, which often engage multiple recipients (e.g., parents and/or children) and address multiple behaviors (e.g., diet, physical activity, screen time).

Dietary patterns and associations with BMI in low-income, ethnic minority youth in the USA according to baseline data from four randomised controlled trials.

Few studies have derived data-driven dietary patterns in youth in the USA. This study examined data-driven dietary patterns and their associations with BMI measures in predominantly low-income, racial/ethnic minority US youth. Data were from baseline assessments of the four Childhood Obesity Prevention and Treatment Research (COPTR) Consortium trials: NET-Works (534 2-4-year-olds), GROW (610 3-5-year-olds), GOALS (241 7-11-year-olds) and IMPACT (360 10-13-year-olds). Weight and height were measured. Children/adult proxies completed three 24-h dietary recalls. Dietary patterns were derived for each site from twenty-four food/beverage groups using k-means cluster analysis. Multivariable linear regression models examined associations of dietary patterns with BMI and percentage of the 95th BMI percentile. Healthy (produce and whole grains) and Unhealthy (fried food, savoury snacks and desserts) patterns were found in NET-Works and GROW. GROW additionally had a dairy- and sugar-sweetened beverage-based pattern. GOALS had a similar Healthy pattern and a pattern resembling a traditional Mexican diet. Associations between dietary patterns and BMI were only observed in IMPACT. In IMPACT, youth in the Sandwich (cold cuts, refined grains, cheese and miscellaneous) compared with Mixed (whole grains and desserts) cluster had significantly higher BMI (ß = 0·99 (95 % CI 0·01, 1·97)) and percentage of the 95th BMI percentile (ß = 4·17 (95 % CI 0·11, 8·24)). Healthy and Unhealthy patterns were the most common dietary patterns in COPTR youth, but diets may differ according to age, race/ethnicity or geographic location. Public health messages focused on healthy dietary substitutions may help youth mimic a dietary pattern associated with lower BMI.

Measuring commissioners' willingness-to-pay for community based childhood obesity prevention programmes using a discrete choice experiment.

BACKGROUND: In the UK, rates of childhood obesity remain high. Community based programmes for child obesity prevention are available to be commissioned by local authorities. However, there is a lack of evidence regarding how programmes are commissioned and which attributes of programmes are valued most by commissioners. The aim of this study was to determine the factors that decision-makers prioritise when commissioning programmes that target childhood obesity prevention. METHODS: An online discrete choice experiment (DCE) was used to survey commissioners and decision makers in the UK to assess their willingness-to-pay for childhood obesity programmes. RESULTS: A total of 64 commissioners and other decision makers completed the DCE. The impact of programmes on behavioural outcomes was prioritised, with participants willing to pay an extra £16,600/year if average daily fruit and vegetable intake increased for each child by one additional portion. Participants also prioritised programmes that had greater number of parents fully completing them, and were willing to pay an extra £4810/year for every additional parent completing a programme. The number of parents enrolling in a programme (holding the number completing fixed) and hours of staff time required did not significantly influence choices. CONCLUSIONS: Emphasis on high programme completion rates and success increasing children's fruit and vegetable intake has potential to increase commissioning of community based obesity prevention programmes.

Longitudinal Associations Between Body Mass Index During Young Adulthood, Subsequent Weight Change, and Incident Diabetes During Mid- and Older-Adulthood in Non-Hispanic White and African American Populations: The Atherosclerosis Risk in Communities Study.

Background: Excess body mass index (BMI) and weight gain are well-known risk factors for diabetes. Nevertheless, the associations of BMI and weight gain in young adulthood with subsequent diabetes in African Americans, and the standardized effects of these weight variables have not been well studied. Methods: We studied 12,672 white and African American men and women 45-64 years of age (i.e., during mid-adulthood) who participated in the Atherosclerosis Risk in Communities Study visit 1 (1987-1989), and were reexamined at three follow-up examinations. Associations between recalled BMI at age 25 (i.e., during young adulthood) and subsequent weight change with incident diabetes at ages 45 and above (i.e., during mid-adulthood to older adulthood) were examined using Cox proportional hazard models. Results: Over the 9-year follow-up, we identified 1,501 cases of incident diabetes. The incidence rates were higher among African Americans (men: 24.5 and women: 26.3 per 1,000 person-years) compared to whites (men: 16.3 and women: 10.5 per 1,000 person years). Compared to normal-weight individuals at age 25, those who were overweight or obese and those who gained more weight after age 25 had a higher risk of developing diabetes later in all four race-sex groups with the highest risk in African Americans. In the race-sex groups combined, the mutually adjusted hazard ratio for BMI at age 25 and percent weight change were 1.97 (1.79-2.17) and 2.89 (2.59-3.11), respectively, comparing the 85th to the 15th percentiles of the exposures. Conclusions: African Americans were at higher risk of diabetes than whites. Both higher BMI at age 25 and subsequent weight gain were independently associated with higher risk for diabetes in all the race-sex groups; however, overall weight gain was more potent than BMI.

Childhood obesity intervention studies: A narrative review and guide for investigators, authors, editors, reviewers, journalists, and readers to guard against exaggerated effectiveness claims.

Being able to draw accurate conclusions from childhood obesity trials is important to make advances in reversing the obesity epidemic. However, obesity research sometimes is not conducted or reported to appropriate scientific standards. To constructively draw attention to this issue, we present 10 errors that are commonly committed, illustrate each error with examples from the childhood obesity literature, and follow with suggestions on how to avoid these errors. These errors are as follows: using self-reported outcomes and teaching to the test; foregoing control groups and risking regression to the mean creating differences over time; changing the goal posts; ignoring clustering in studies that randomize groups of children; following the forking paths, subsetting, p-hacking, and data dredging; basing conclusions on tests for significant differences from baseline; equating "no statistically significant difference" with "equally effective"; ignoring intervention study results in favor of observational analyses; using one-sided testing for statistical significance; and stating that effects are clinically significant even though they are not statistically significant. We hope that compiling these errors in one article will serve as the beginning of a checklist to support fidelity in conducting, analyzing, and reporting childhood obesity research.

Two Family Interventions to Reduce BMI in Low-Income Urban Youth: A Randomized Trial.

BACKGROUND: Our primary aim was to evaluate the effects of 2 family-based obesity management interventions compared with a control group on BMI in low-income adolescents with overweight or obesity. METHODS: In this randomized clinical trial, 360 urban-residing youth and a parent were randomly assigned to 1 of 2 behaviorally distinct family interventions or an education-only control group. Eligible children were entering the sixth grade with a BMI ≥85th percentile. Interventions were 3 years in length; data were collected annually for 3 years. Effects of the interventions on BMI slope (primary outcome) over 3 years and a set of secondary outcomes were assessed. RESULTS: Participants were primarily African American (77%), had a family income of <25 000 per year, and obese at enrollment (68%). BMI increased over time in all study groups, with group increases ranging from 0.95 to 1.08. In an intent-to-treat analysis, no significant differences were found in adjusted BMI slopes between either of the family-based interventions and the control group (P = .35). No differences were found between the experimental and control groups on secondary outcomes of diet, physical activity, sleep, perceived stress, or cardiometabolic factors. No evidence of effect modification of the study arms by sex, race and/or ethnicity, household income, baseline levels of child and parent obesity, or exposure to a school fitness program were found. CONCLUSIONS: In this low-income, adolescent population, neither of the family-based interventions improved BMI or health-related secondary outcomes. Future interventions should more fully address poverty and other social issues contributing to childhood obesity.