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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
Must not have
Adolescents will be excluded from study participation if they have absolute BMI greater than 50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 4-, 12-, 18- months after randomization
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My BMI is not over 50.

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

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common weight loss treatments, such as those in the HealthTRAC program, combine emotion regulation skill building and behavioral weight control. Emotion regulation helps patients manage stress and emotional triggers that can lead to overeating, while behavioral weight control involves structured interventions like dietary planning, physical activity, and self-monitoring. This dual approach addresses both the psychological and behavioral aspects of weight management, promoting sustainable lifestyle changes and improving overall emotional well-being, which is crucial for long-term weight loss success.
Treatment of compulsive exercise in eating disorders and muscle dysmorphia: protocol for a systematic review.Treated individuals who progress to action or maintenance for one behavior are more likely to make similar progress on another behavior: coaction results of a pooled data analysis of three trials.The effectiveness of psychosocial modalities in the treatment of alcohol problems in adults: a review of the evidence.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityOTHER
985 Previous Clinical Trials
7,385,524 Total Patients Enrolled
2 Trials studying Weight Loss
50 Patients Enrolled for Weight Loss
The Miriam HospitalLead Sponsor
241 Previous Clinical Trials
37,388 Total Patients Enrolled
34 Trials studying Weight Loss
5,029 Patients Enrolled for Weight Loss
Rhode Island HospitalOTHER
262 Previous Clinical Trials
68,832 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
~47 spots leftby Aug 2025