What side effects are associated with this type of intervention?

Common treatments for weight loss that combine emotion regulation skill building and behavioral weight control, such as the HealthTRAC intervention, generally have minimal side effects. Behavioral weight control programs may include dietary changes and increased physical activity, which can sometimes lead to temporary gastrointestinal discomfort, muscle soreness, or fatigue. Emotion regulation skill building is typically a component of cognitive-behavioral therapy (CBT), which is well-tolerated but may initially cause emotional distress as individuals confront and work through challenging feelings. Overall, these interventions are considered safe and effective for weight management.

What prior FDA approvals exist?

The FDA has approved several drugs for weight loss that combine behavioral and pharmacological approaches. Notable examples include bupropion-naltrexone, which combines a dopamine-reuptake inhibitor with an opioid-receptor antagonist to reduce food intake and manage weight. Another example is the combination of phentermine-topiramate, which includes a sympathomimetic amine anorectic and an anticonvulsant to promote weight loss. These treatments are often used alongside lifestyle interventions such as diet and exercise, aligning with the behavioral weight control aspects of the HealthTRAC intervention.

What other types of research exist?

Promising novel alternatives to HealthTRAC for weight loss patients in 2024 include: 1) Integrative Cognitive-Affective Therapy (ICAT-BED), which targets momentary behavioral and emotional triggers of binge eating. 2) Digital self-help interventions, such as internet-based guided self-help and smartphone applications like Noom Monitor, which support self-monitoring and behavioral change. 3) Lifestyle therapies focusing on holistic health, such as yoga and mindfulness-based stress reduction, which can improve emotion regulation and support weight management.

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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

No Placebo-Only Group

Summary

This trial tests the HealthTRAC program, which helps overweight or obese teenagers manage their weight by teaching them how to handle their emotions better. The program combines lessons on emotional control with healthy eating and physical activity strategies. It aims to help these teens lose weight and maintain a healthier lifestyle. The HealthTRAC intervention has shown to be acceptable, feasible to deliver, and positively impacts BMI and emotion regulation abilities in overweight/obese adolescents.

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.

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.

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

Select...

I am between 13 and 17 years old.

Select...

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:

Select...

My BMI is not over 50.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 4-, 12-, 18- months after randomization

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in BMI from baseline to 12 months post-intervention

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met

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.