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Life sciences · Interventional Study
ClinicalTrials.gov · October 22, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT04861636). This is a study registration, not published results. Lead sponsor: The Miriam Hospital. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 172 participants (ACTUAL). Conditions: Adolescent Obesity, Weight Loss. Interventions: BEHAVIORAL: HealthTRAC; BEHAVIORAL: SBWC. Primary outcome measures: Change in BMI from baseline to 12 months post-intervention , baseline and 12 months after randomization. Brief summary: 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.