Teen Weight Control

NCT04861636 | Active Not Recruiting DMC

• 1 other identifier: R01DK12455101
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 3

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.

Conditions

Adolescent Obesity; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Change in BMI from baseline to 12 months post-intervention

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

  baseline and 12 months after randomization

Secondary Outcomes (5)

• Examine the impact of HealthTRAC relative to SBWC on emotion regulation

  baseline and 4-, 12-, 18- months after randomization

• Examine the impact of HealthTRAC relative to SBWC on emotional eating

  baseline and 4-, 12-, 18- months after randomization

• Examine the impact of HealthTRAC relative to SBWC on dietary intake

  baseline and 4-, 12-, 18- months after randomization

• Examine the impact of HealthTRAC relative to SBWC on physical activity and sedentary behavior

  baseline and 4-, 12-, 18- months after randomization

• Examine the impact of HealthTRAC relative to SBWC on screen time

  baseline and 4-, 12-, 18- months after randomization

Study Arms (2)

HealthTRAC

EXPERIMENTAL

Both the standard behavioral weight control (SBWC) and HealthTRAC interventions include 4 months of intensive treatment, followed by monthly maintenance sessions for a 12-month program. SBWC includes attention to diet and activity coupled with behavioral modification strategies. HealthTRAC integrates these key constructs with an emotion regulation intervention with documented efficacy in teens.

Behavioral: HealthTRAC

Standard Behavioral Weight Control (SBWC)

ACTIVE COMPARATOR

4 months of intensive treatment focused on attention to diet and activity coupled with behavioral modification strategies, which is then followed by monthly maintenance sessions for a 12-month program.

Behavioral: SBWC

Interventions

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.

HealthTRAC

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.

Standard Behavioral Weight Control (SBWC)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants must:
• be between 13 and 17 years of age
• have BMI greater than or equal to the 95th percentile for age and sex
• have a parent or guardian available to participate in the study
• speak English due to the group format of the intervention
• agree to study participation, measures, and randomization
• be available for long-term follow-up.

You may not qualify if:

• Adolescents will be excluded from study participation if they:
• have absolute BMI greater than 50
• are currently involved with another weight loss program
• have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity
• have a developmental delay such that the intervention materials will not be appropriate
• 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.

Sponsors & Collaborators

• The Miriam Hospital: lead
• Rhode Island Hospital: collaborator
• University of Oregon: collaborator
• Oregon Health and Science University: collaborator

Study Sites (3)

University of Oregon

Eugene, Oregon, 97403, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Elissa Jelalian, PhD

  Elissa_Jelalian@brown.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both the standard behavioral weight control (SBWC) and HealthTRAC interventions include 4 months of intensive treatment, followed by monthly maintenance sessions for a 12-month program. SBWC includes attention to diet and activity coupled with behavioral modification strategies. HealthTRAC integrates these key constructs with an emotion regulation intervention with documented efficacy in teens.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 27, 2021
• Study Start: May 1, 2021
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)