Clinical trial

Teen Weight Control

Active, not recruiting ยท Not applicable ยท 1 countries ยท Registry ID NCT04861636

Active, not recruitingNot applicableInterventional

What this study is about

The prevalence of obesity in adolescents is remarkably high, with 38.7% of youth 12-15 years of age and 41.5% of 16-19 year olds meeting criteria for overweight or obesity. Behavioral weight control interventions for adolescents have had limited impact on this field and there is considerably more that needs to be done. Notably, adolescents who have difficulty managing their feelings have been found to consume higher caloric foods and report greater amounts of sedentary time. Poor emotion management among adolescents has also been associated with more rapid weight gain and higher BMI. Data from adolescents with overweight/obesity attending our outpatient weight management program (N=124) indicate that 82% of these youth report emotion regulation scores that are comparable to youth with significant mental health problems. Despite documented relationships between adolescent weight control and emotion regulation, no proven adolescent weight management programs targeting emotion regulation exist. To fill this gap, our laboratory developed and piloted an adolescent weight control intervention (HealthTRAC) that combines two previously tested effective interventions, one targeting emotion regulation skill building, the other focused on behavioral weight control. Findings from our small pilot trial are promising and indicate that the newly created HealthTRAC intervention is acceptable to parents and teens, easy to deliver, and leads to modest weight loss and improved emotion management skills compared to a standard behavioral weight control (SBWC) program. These data suggest that emotion regulation is related to weight management and may assist adolescents with overweight/obesity who are seeking to lose weight. The current multi-site study builds on this previous work and will examine the impact of the developed HealthTRAC intervention on improving emotion regulation skills and reducing adolescent BMI in a larger sample with longer term follow-up (18 months after starting the intervention). Adolescents will receive 27.5 hours of intervention time over a 12- month period. We expect that adolescents enrolled in the HealthTRAC intervention will show greater reduction in BMI over the 12-month program and will sustain these losses up to 18 months after starting the intervention compared to teens enrolled in SBWC. The information learned from this project will help us better understand how helping adolescents manage their emotions can improve weight loss outcomes.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age13 Years to 17 Years
SexAll
Healthy volunteersNot accepted
ConditionAdolescent Obesity, Weight Loss

Full registry criteria

INCLUSION CRITERIA: Participants must: 1. be between 13 and 17 years of age 2. have BMI greater than or equal to the 95th percentile for age and sex 3. have a parent or guardian available to participate in the study 4. speak English due to the group format of the intervention 5. agree to study participation, measures, and randomization 6. be available for long-term follow-up. EXCLUSION CRITERIA: Adolescents will be excluded from study participation if they: 1. have absolute BMI greater than 50 2. are currently involved with another weight loss program 3. have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity 4. have a developmental delay such that the intervention materials will not be appropriate 5. report engaging in extreme/unhealthy weight control behaviors including self-induced vomiting, laxative or diuretic use, or report a history of eating disorder, and/or are actively psychotic or suicidal at the time of screening.

Treatments and study arms

HealthTRAC

Behavioral

Behavioral weight management intervention targeting emotion regulation skill building. Intervention components will be delivered in 27.5 hours of direct contact time across 12 months. All adolescents will be assessed prior to randomization (baseline), immediately following the intervention (4 months), upon completion of maintenance sessions (12 months) and 18 months after the start of intervention.

SBWC

Behavioral

Behavioral intervention focused on behavioral weight control. Intervention components will be delivered in 27.5 hours of direct contact time across 12 months. All adolescents will be assessed prior to randomization (baseline), immediately following the intervention (4 months), upon completion of maintenance sessions (12 months) and 18 months after the start of intervention.

Primary outcomes

Change in BMI from baseline to 12 months post-interventionbaseline and 12 months after randomization

Weight (kilograms) and height (meters\^2) will be used to calculate body mass index (BMI; kg/m\^2)

Study locations

3 locations were listed when this page was built. The first 40 are shown.

University of Oregon๐Ÿ‡บ๐Ÿ‡ธ Eugene, Oregon, United States
Oregon Health & Science University๐Ÿ‡บ๐Ÿ‡ธ Portland, Oregon, United States
The Miriam Hospital๐Ÿ‡บ๐Ÿ‡ธ Providence, Rhode Island, United States