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Emotional Management Intervention for Teen Obesity (HealthTRAC Trial)

N/A
Recruiting
Led By Elissa Jelalian, PhD
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be between 13 and 17 years of age
Have BMI greater than or equal to the 95th percentile for age and sex
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 4-, 12-, 18- months after randomization
Awards & highlights

HealthTRAC Trial 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.

Who is the study for?
This trial is for teens aged 13-17 with obesity, defined as having a BMI at or above the 95th percentile for their age and sex. They must speak English, have a parent or guardian to participate alongside them, be available for long-term follow-up, and agree to random assignment in the study. Teens with developmental delays, extreme obesity (BMI >50), medical conditions affecting diet/exercise, unhealthy weight control behaviors, eating disorders, or severe mental health issues are excluded.Check my eligibility
What is being tested?
The trial tests HealthTRAC intervention against standard behavioral weight control (SBWC). HealthTRAC focuses on emotion regulation skill building combined with behavioral weight management techniques. Over a year-long period totaling 27.5 hours of intervention time, it aims to improve emotional management skills and reduce BMI in adolescents more effectively than SBWC alone.See study design
What are the potential side effects?
While specific side effects aren't detailed here since this isn't a drug trial but rather lifestyle interventions focused on behavior modification and emotional support may include feelings of frustration or stress during adjustment periods.

HealthTRAC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 13 and 17 years old.
Select...
My BMI is in the top 5% for my age and sex.

HealthTRAC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 4-, 12-, 18- months after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4-, 12-, 18- months after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in BMI from baseline to 12 months post-intervention
Secondary outcome measures
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
+2 more

HealthTRAC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HealthTRACExperimental Treatment1 Intervention
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.
Group II: Standard Behavioral Weight Control (SBWC)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityOTHER
968 Previous Clinical Trials
6,845,586 Total Patients Enrolled
2 Trials studying Weight Loss
50 Patients Enrolled for Weight Loss
The Miriam HospitalLead Sponsor
238 Previous Clinical Trials
37,405 Total Patients Enrolled
34 Trials studying Weight Loss
5,030 Patients Enrolled for Weight Loss
Rhode Island HospitalOTHER
260 Previous Clinical Trials
71,534 Total Patients Enrolled

Media Library

HealthTRAC Clinical Trial Eligibility Overview. Trial Name: NCT04861636 — N/A
Weight Loss Research Study Groups: HealthTRAC, Standard Behavioral Weight Control (SBWC)
Weight Loss Clinical Trial 2023: HealthTRAC Highlights & Side Effects. Trial Name: NCT04861636 — N/A
HealthTRAC 2023 Treatment Timeline for Medical Study. Trial Name: NCT04861636 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research include participants of 40 years or older?

"For this research study, they are specifically looking for adolescents aged between 13 and 17 years old."

Answered by AI

What is the highest potential participation for this clinical experiment?

"Affirmative. Research on clinicaltrials.gov shows that this study, first announced May 1st 2021, is still recruiting participants. A cohort of 200 people will be enrolled from 3 different medical locations."

Answered by AI

Are there any open slots for participants in this study?

"Affirmative. Clinicaltrials.gov displays that this trial, which opened recruitment on the 1st of May 2021, is in current motion. 200 participants are being sought from 3 distinct locations."

Answered by AI

To whom is this research opportunity open?

"This trial is recruiting 200 minors aged 13 to 17 who are struggling with weight loss. To be considered eligible for the study, participants must consent to clinical testing and randomization protocols, possess a BMI higher than the 95th percentile for their age group and sex, have an adult guardian who will partake in the research process, remain available throughout long-term follow-up sessions."

Answered by AI

Who else is applying?

What state do they live in?
Rhode Island
What site did they apply to?
University of Oregon
The Miriam Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am having trouble losing weight and keeping it off.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Is there a location other than Miriam?
PatientReceived no prior treatments
~63 spots leftby Aug 2025