Study Summary
This trial is testing whether an intervention that helps adolescents manage their emotions can lead to better weight loss outcomes compared to a standard behavioral weight control program.
Eligible Conditions
- Adolescent Obesity
- Weight Loss
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: baseline and 4-, 12-, 18- months after randomization
Month 12
Change in BMI from baseline to 12 months post-intervention
baseline and 4-, 12-, 18- months after randomization
Examine the impact of HealthTRAC relative to SBWC on dietary intake
Examine the impact of HealthTRAC relative to SBWC on emotion regulation
Examine the impact of HealthTRAC relative to SBWC on emotional eating
Examine the impact of HealthTRAC relative to SBWC on physical activity and sedentary behavior
Examine the impact of HealthTRAC relative to SBWC on screen time
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard Behavioral Weight Control (SBWC)
1 of 2
HealthTRAC
1 of 2
Active Control
Experimental Treatment
200 Total Participants · 2 Treatment Groups
Primary Treatment: HealthTRAC · No Placebo Group · N/A
HealthTRAC
Behavioral
Experimental Group · 1 Intervention: HealthTRAC · Intervention Types: BehavioralStandard Behavioral Weight Control (SBWC)
Behavioral
ActiveComparator Group · 1 Intervention: SBWC · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 4-, 12-, 18- months after randomization
Who is running the clinical trial?
Rhode Island HospitalOTHER
239 Previous Clinical Trials
59,114 Total Patients Enrolled
The Miriam HospitalLead Sponsor
227 Previous Clinical Trials
35,718 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
895 Previous Clinical Trials
6,831,105 Total Patients Enrolled
University of OregonOTHER
68 Previous Clinical Trials
32,531 Total Patients Enrolled
Elissa Jelalian, PhDPrincipal InvestigatorElissa_Jelalian@brown.edu
3 Previous Clinical Trials
282 Total Patients Enrolled
Eligibility Criteria
Age 13 - 17 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Most of the participants in the study were able to improve their English skills because the intervention was conducted in a group format.
agree to agree to study the effects of participating in the study, the measures that will be used, and the process by which participants will be randomly assigned to groups.
You are between 13 and 17 years of age.
BMI greater than or equal to the 95th percentile means that the person's weight is too high.
The study requires a parent or guardian to participate.
remain available for long-term follow-up.
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Conditions
Cancer Related
Treatments