Additional Study Information

The Childhood Obesity Prevention and Treatment Research (COPTR) consortium was created to develop and evaluate novel approaches to prevent or treat childhood obesity. The COPTR consortium ran four community-based randomized controlled trials that were independent but shared common measurements and data collection protocols. All four trials ran for 3 years, had multi-level interventions, and enrolled low-income racial/ethnic minority populations.

Objectives

The NET-Works study was designed to evaluate a multicomponent obesity prevention intervention among diverse, low-income preschoolers. The GROW study was designed to test the effect of a multicomponent behavioral intervention on child body mass index (BMI) growth trajectories among preschool-age children at risk for obesity. The IMPACT study was designed to evaluate the effects of two family-based obesity management interventions compared with a control group on BMI in low-income children who were overweight or obese. The Stanford GOALS study was designed to test the effects of a community-based, multi-component, multi-level, multi-setting approach for treating overweight and obese children.

Background

Childhood obesity is a serious health problem that has been associated with hypertension, dyslipidemias, early atherosclerotic lesions, hyperinsulinemia, insulin resistance and type 2 diabetes mellitus, and many other medical, psychological, and social complications. The contributors to childhood obesity are multifaceted and include the neighborhood environment, social influences, economic factors, the home environment, parenting behaviors, and child behavioral and biological factors. At the time of the COPTR consortium clinical trials, clinical childhood obesity treatment programs were expensive and time-consuming to implement, able to serve only limited numbers of children, not available in all communities, often inconvenient for children and families to attend, and generally produced only modest outcomes. As the prevalence of childhood obesity has grown, innovative feasible, accessible, affordable, and effective weight control programs are greatly needed, especially for low income and minority children who are disproportionately affected.

Participants

NET-Works:

A child was eligible for the study if the child was aged between 2 and 4 years, did not use any medications that would affect the child’s growth, had BMI greater than or equal to the 50th percentile according to Centers for Disease Control and Prevention (CDC) age and sex reference standards, had a family income of less than $65 000 per year, had a parent who agreed to participate in the study, and had a parent who spoke English or Spanish.

534 children were randomized, with 269 randomized to the usual care arm and 265 to the intervention arm.

GROW:

A child was eligible for the study if the child was aged between 3 and 5 years, had high normal weight to overweight but not yet obese (BMI ≥50th and <95th percentile based on CDC standardized growth curves), had a parent who agreed to participate in the study, and had a parent who spoke English or Spanish.

610 parent-child pairs were randomized, with 304 randomized to the intervention group and 306 to the control group.

IMPACT:

A child was eligible for the study if the child had a BMI ≥85th percentile and was entering the sixth grade. A child was excluded if he or she was taking medications that alter appetite or weight, had stage 2 hypertension or stage 1 hypertension with end organ damage, had type 1 or 2 diabetes, had sickle cell disease, or had a known medical condition that itself causes obesity.

360 children were randomized, with 119 randomized to the control group, 118 to the Healthy Change group, and 123 to the System Change group.

Stanford GOALS:

A child was eligible for the study if the child was aged between 7 and 11 years with a BMI ≥ 85th percentile for age and sex on the 2000 CDC BMI reference at the time of baseline measurement, as well as, a parent that understands English or Spanish. A child was excluded if he or she had been diagnosed with a medical condition that affects growth or was taking a medication that affects growth.

241 children were randomized.

Design

The COPTR consortium required a minimum set of baseline data to be collected before a participant could be randomized. These included measured height and weight, common demographic information, a minimum of two 24-hour dietary recalls (GOALS required three), a minimum of three weekdays and one weekend day of accelerometer wear data with at least 6 hours of useable data each day, and fasting blood samples (GOALS and IMPACT). All participants completed assessments at baseline, 12 months, 24 months, and 36 months.

NET-Works:

The NET-Works study was a 2-arm, randomized controlled trial with the child as the unit of randomization and evaluation. Participants were recruited in partnership with 12 Minneapolis–St Paul, Minnesota, primary care clinics that serve diverse populations. The study coordinator assigned children to condition according to age-by-gender stratified block randomization schedules. The intervention program consisted of home visiting, community-based parenting classes, and telephone check-in calls. Referrals to community resources for healthy foods and physical activity opportunities were embedded in the home visiting and parenting class components. Home visits were about 1 hour in duration and were planned for monthly intervals with telephone check-in calls between home visits. Parenting classes were held weekly for 12 weeks in the communities where the families resided. Child television viewing and computer use was computed by using the parent-reported average hours per day. A primary care provider intervention component was included for both intervention and usual care groups. Providers were trained to discuss child BMI with the parent at the annual well-child visit, by using a study-provided pamphlet with the child’s BMI percentile and messages about healthful eating and physical activity for the child. In addition, parents randomized to the usual care condition received quarterly postcards that focused on child development and school readiness. Process evaluation staff not involved in the intervention activities conducted phone surveys with study participants in both conditions every 6 months.

The primary outcomes were adjusted 24- and 36-month BMI.

GROW:

The GROW study was a randomized clinical trial. Parent-child pairs were recruited from 54 physicians’ offices and community settings in Nashville, Tennessee. Participants were randomized using a computer-generated schedule that was stratified by community center and parent language preference (English or Spanish). The intervention, GROW Healthier, was a tiered-intensity program of decreasing intensity. The intervention began with a 12-week intensive phase with weekly 90-minute skills-building sessions via either in-person groups or telephone calls; followed by a 9-month maintenance phase with monthly coaching telephone calls; and lastly, a 24-month sustainability phase providing frequent contact to use parks and recreation programming for healthy family behaviors. Intervention content included skills building for parents and children regarding nutritional choices, physical activity habits, use of the family and built environment, engaged parenting, healthy sleep, and reduced media time. The control condition, GROW Smarter, was a school-readiness program developed and delivered by the Nashville Public Library. The curriculum consisted of six 30-minute group-based activities delivered concurrently with data collection sessions. Participants in the intervention and control groups both received the school-readiness program.

The primary outcome was child BMI trajectory across 36 months.

IMPACT:

The IMPACT study was a 3-group randomized controlled trial. Participants were recruited as part of an existing BMI and blood pressure (BP) screening program in the Cleveland Metropolitan School District and 5 charter schools. The Healthy Change intervention consisted of behavior change strategies commonly used in cognitive behavioral and motivational interviewing interventions, such as problem-solving, goal setting, self-monitoring, and relapse-prevention skills. The System Change intervention was based on process improvement techniques and emphasized restructuring family daily routines (systems) to establish new healthy living habits. Both interventions focused on the same healthy living behaviors of diet, physical activity, sedentary activity, sleep, and stress management. Both interventions involved small group sessions of 12 to 15 families who met in 25 face-to-face sessions in Year 1, alternating monthly face-to-face group and individualized telephone sessions in Year 2, and 4 face-to-face and 8 telephone sessions in Year 3. Participants additionally received up to 60 minutes of personal coaching each month if they met any of the following 4 criteria: identified as a binge eater, morbidly obese at baseline (>99.5 BMI percentile), low parent and/or family involvement (adolescent attending >50% of sessions alone without a parent), or excessive weight gain during the study (>2 lb per month in a 3-month period resulting in an increase in BMI). Participants in the control arm received 1 hour of private coaching from a registered dietitian on healthy eating and physical activity in Year 1 as well as a social telephone call and social event in all study years to enhance study retention.

The primary outcome was BMI trajectory across 36 months.

Stanford GOALS:

Stanford GOALS was a two-arm, parallel group, randomized controlled trial to test the efficacy of a multi-component, multi-level, multi-setting approach to treating overweight and obese children. Eligible participants were recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. The treatment condition intervention included three major components: a community-based after school team sports program designed specifically for overweight and obese children; a home-based family intervention to reduce portion size, promote changes in diet and physical activity, reduce screen time, and promote self-regulatory skills for eating and activity behavior change; and a primary care provider behavioral counseling intervention linked to the community and home interventions. The control condition included semi-annual home visits with a home interventionist for education about nutrition, separate monthly health education newsletters for children and for parents/guardians, and a series of quarterly evening health lectures and Family Fun Nights at neighborhood community centers or school sites.

The primary outcome measure was change in BMI during the 36-month study.

Robinson TN, Matheson D, Desai M, et al. Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention. Contemp Clin Trials. 2013;36(2):421-435. doi:10.1016/j.cct.2013.09.001

Conclusions

NET-Works:

The interventions did not significantly reduce BMI increases among diverse, low-income preschoolers. However, there was a reduction in BMI increases among Hispanic children and children who were overweight or obese at baseline.

French SA, Sherwood NE, Veblen-Mortenson S, et al. Multicomponent Obesity Prevention Intervention in Low-Income Preschoolers: Primary and Subgroup Analyses of the NET-Works Randomized Clinical Trial, 2012-2017. Am J Public Health. 2018;108(12):1695-1706. doi:10.2105/AJPH.2018.304696

GROW:

The long-term community-based, family-centered, behavioral intervention did not change BMI trajectory in underserved preschool children who were not yet obese.

Barkin SL, Heerman WJ, Sommer EC, et al. Effect of a Behavioral Intervention for Underserved Preschool-Age Children on Change in Body Mass Index: A Randomized Clinical Trial. JAMA. 2018;320(5):450-460. doi:10.1001/jama.2018.9128

IMPACT:

Neither of the long-term family interventions tested in this randomized trial improved BMI in low-income children who were overweight or obese.

Moore SM, Borawski EA, Love TE, et al. Two Family Interventions to Reduce BMI in Low-Income Urban Youth: A Randomized Trial. Pediatrics. 2019;143(6):e20182185. doi:10.1542/peds.2018-2185

Stanford GOALS:

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.

Robinson TN, Matheson D, Wilson DM, Weintraub DL, Banda JA, McClain A, Sanders LM, Haskell WL, Haydel KF, Kapphahn KI, Pratt C, Truesdale KP, Stevens J, Desai M. 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. Lancet Diabetes Endocrinol. 2021 Jun;9(6):336-349. doi: 10.1016/S2213-8587(21)00084-X. Epub 2021 Apr 29. PMID: 33933181; PMCID: PMC8241238.

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