Emotional Management Intervention for Teen Obesity

(HealthTRAC Trial)

Not currently recruiting at 2 trial locations

Overseen By Elissa Jelalian, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Disqualifiers: BMI over 50, Eating disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist teens struggling with both obesity and emotional management. It will test a new program called HealthTRAC, which combines emotion management techniques with traditional weight control strategies. Teens who have difficulty controlling their emotions often consume more high-calorie foods and gain weight more rapidly. The trial seeks teens aged 13 to 17 with a high BMI (a measure of body fat based on height and weight) who wish to lose weight and enhance their emotional well-being. Participants will join a 12-month program with follow-up checks to evaluate the effectiveness of the strategies over time.

As an unphased trial, this study provides a unique opportunity for teens to participate in innovative research that could significantly improve their health and emotional well-being.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a medical condition that interferes with the dietary plan or physical activity, you may be excluded from the study.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the HealthTRAC program is safe and well-received by teens. In earlier studies, both teens and their parents found the treatment acceptable. The program includes methods for handling emotions and controlling weight, both tested separately and proven effective. Available data report no serious side effects, suggesting that the HealthTRAC approach is a promising way to help teens manage their weight and emotions without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HealthTRAC because it combines traditional weight control strategies with an innovative emotion regulation intervention specifically for teens. Most treatments for teen obesity focus on diet, physical activity, and behavior changes. However, HealthTRAC adds a unique twist by integrating emotion management, which has shown success in helping teens handle emotions that might lead to overeating. This makes HealthTRAC stand out, as it not only addresses physical health but also targets emotional well-being, potentially leading to more lasting results.

What evidence suggests that the HealthTRAC intervention might be an effective treatment for teen obesity?

Research has shown that the HealthTRAC program, available to participants in this trial, can help teens manage their weight by teaching emotional regulation. In a small initial study, teens in the HealthTRAC program lost some weight and improved emotional control compared to those in the Standard Behavioral Weight Control (SBWC) program, another treatment option in this trial. The study found that both parents and teens favored the HealthTRAC program. These early results suggest that learning to manage emotions might help teens with overweight or obesity better control their weight. ^{1 2 6 7 8}

Who Is on the Research Team?

Elissa Jelalian, PhD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Agree to study participation, measures, and randomization

I am between 13 and 17 years old.

Be available for long-term follow-up

Exclusion Criteria

You have a history of unhealthy weight control behaviors like vomiting or using laxatives, or have a current eating disorder. You are also excluded if you have current severe mental health issues like suicidal thoughts or severe psychosis.

Have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity

You have a learning disability that would make it difficult for you to use the study's educational materials.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-month weight control intervention including 12 weekly sessions and 2 bi-weekly sessions over 4 months, followed by 8 months of maintenance sessions.

12 months

14 primary sessions (in-person), monthly maintenance sessions

Follow-up

Participants are monitored for sustainability of intervention effects and changes in BMI and emotion regulation skills.

18 months

Assessments at 12 and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• HealthTRAC
• SBWC

Trial Overview 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.

How Is the Trial Designed?

Group I: HealthTRAC Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Rhode Island Hospital

Collaborator

Trials

275

Recruited

71,400+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

Published Research Related to This Trial

The study aims to evaluate the effectiveness of adding emotion regulation training to standard multidisciplinary obesity treatment for 140 young inpatients (ages 10-14) to improve their emotional eating and adaptive coping strategies.

Participants will be assessed before and after the training, as well as at a 6-month follow-up, to determine improvements in emotional regulation, weight loss, sleep quality, and overall psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion regulation training in the treatment of obesity in young adolescents: protocol for a randomized controlled trial. Debeuf, T., Verbeken, S., Boelens, E., et al.[2020]

The Multidisciplinary Obesity Treatment (MOT) significantly reduced physiological stress responses in youth with obesity, as evidenced by lower resting heart rates and improved heart rate variability after 12 weeks of treatment.

Adding emotion regulation (ER) training to MOT did not show additional benefits for physiological stress parameters, but the experimental group did experience further improvements in stress responses compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Effects on Psychophysiological Stress Responses in Youth With Obesity. Van Royen, A., Verbiest, I., Goemaere, H., et al.[2023]

A 12-month structured multidisciplinary weight management program for 77 obese children led to a significant reduction in BMI from 25.9 to 24.5 kg/m² and BMI percentiles from 97.3% to 92.6%, indicating its efficacy in managing childhood obesity.

Children with higher initial BMI percentiles and those with overweight parents showed less favorable outcomes from the intervention, suggesting that these factors may influence the success of weight management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental obesity and higher pre-intervention BMI reduce the likelihood of a multidisciplinary childhood obesity program to succeed--a clinical observation. Eliakim, A., Friedland, O., Kowen, G., et al.[2022]

The HealthTRAC program, which combines emotion regulation training and a behavioral weight management intervention, was found to be acceptable and feasible for adolescents aged 13 to 17, with 84% of participants completing the study.

Adolescents in the HealthTRAC group experienced greater reductions in BMI and reported improved emotion regulation skills compared to those in the standard behavioral weight management condition, indicating that enhancing emotion regulation may support better weight management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Impact of an Adapted Emotion Regulation Intervention for Adolescents with Overweight and Obesity Attempting to Lose Weight. Hadley, W., Houck, C., Barker, D., et al.[2022]

About 25% of overweight or obese youth seeking weight management treatment showed at-risk psychosocial symptoms, indicating a significant prevalence of potential mental health issues among this group.

The study found that there was only fair agreement (24% to 40%) between youth and caregiver reports on psychosocial symptoms, highlighting the importance of including both perspectives in assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial Screening Among Youth Seeking Weight Management Treatment. Ratcliff, MB., Catlin, PA., Peugh, JL., et al.[2019]

The multidisciplinary cognitive behavioral therapy program led to a significant reduction in BMI-SDS by 0.6, which corresponds to an 18.7% weight loss in overweight and obese children after one year, indicating its efficacy.

The study noted a 33% dropout rate, with older participants and those who had less success in reducing BMI-SDS being more likely to drop out, suggesting these factors may predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cognitive behavioral therapy program for overweight children. van den Akker, EL., Puiman, PJ., Groen, M., et al.[2018]

A study involving 50 children and adolescents with obesity showed that adding emotion regulation (ER) training to multidisciplinary obesity treatment (MOT) was feasible, with positive evaluations from participants and trainers on most feasibility criteria.

The training highlighted the need for modifications, such as addressing homework compliance and session length, to enhance the effectiveness of ER strategies like cognitive reappraisal, distraction, and acceptance in managing emotional eating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief emotion regulation training in children and adolescents with obesity: A feasibility study. Boelens, E., Braet, C., Debeuf, T., et al.[2022]

Individuals with obesity show significant emotional processing impairments, including higher levels of alexithymia and difficulty identifying feelings, compared to control groups, based on a systematic review of 31 studies.

Those with obesity, particularly those with binge eating disorder (BED), exhibit lower emotional awareness and less effective emotion regulation strategies, suggesting an emotional avoidance style rather than a general deficit in emotion processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotional processing in obesity: a systematic review and exploratory meta-analysis. Fernandes, J., Ferreira-Santos, F., Miller, K., et al.[2018]

In a study of 100 adolescents with high BMI, those who completed a 6-month treatment with sibutramine achieved an average BMI reduction of 3.1 kg/m2 (about 9.3%), with 79% meeting their weight loss goals.

Key predictors of successful weight loss included the dosage of sibutramine at 3 months and the adolescents' perception of their relationship with their parents, indicating that both medication management and family dynamics play a role in weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary intervention with sibutramine: assessing successful weight loss predictors in military adolescent dependents. Cabrera, JL., Wilks, EG., Symons, JE., et al.[2019]

A 1-year multidisciplinary, family-centered intervention for obese children and adolescents led to a significant decrease in BMI z-scores, indicating effective prevention of further weight gain among the 42 participants aged 8-17.

Quality of life (QoL) significantly improved for both children and parents, with notable enhancements in physical and emotional functioning scores, suggesting that the intervention positively impacted overall well-being despite no changes in body fat percentage or waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Health Initiative Program for Kids (HIP Kids): effects of a 1-year multidisciplinary lifestyle intervention on adiposity and quality of life in obese children and adolescents--a longitudinal pilot intervention study. Bock, DE., Robinson, T., Seabrook, JA., et al.[2018]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04861636/teen-weight-control

Teen Weight Control | Clinical Research Trial Listing Findings from our small pilot trial are promising and indicate that the newly created HealthTRAC intervention is acceptable to parents and teens ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/36/NCT04861636/ICF_000.pdf

NCT # NCT04861636 Teen Weight Control (HealthTRAC) In this study we are trying to learn more about the best ways to help teens lose weight and follow national health guidelines such as engaging in physical ...

3. reporter.nih.gov reporter.nih.gov/search/gkBYlmPyeE-swDy72UkFdA/project-details/10884504

Enhancing Emotion Regulation to Support Weight Control ... PROJECT SUMMARY/ABSTRACT The prevalence of adolescents struggling with excess weight is remarkably high, with 38.7% of 12-15 year-olds and 41.5% of 16-19 ...

4. withpower.com withpower.com/trial/phase-pediatric-obesity-4-2021-16a10

Emotional Management Intervention for Teen Obesity · Info ... This trial tests the HealthTRAC program, which helps overweight or obese teenagers manage their weight by teaching them how to handle their emotions better.

5. researchgate.net researchgate.net/publication/343387019_Preliminary_Impact_of_an_Adapted_Emotion_Regulation_Intervention_for_Adolescents_with_Overweight_and_Obesity_Attempting_to_Lose_Weight

Preliminary Impact of an Adapted Emotion Regulation ... Adolescents in both conditions reported high treatment satisfaction. Adolescents randomized to HealthTRAC demonstrated greater reductions in BMI ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7483247/

Obesity Treatment Among Adolescents: A Review of ... The Endocrine Society defines a BMI decrease of 1.5 to have modest but significant effects on adolescents with obesity, while also stating that at least 7% ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6887808/

Childhood and Adolescent Obesity in the United States Childhood and adolescent obesity have reached epidemic levels in the United States. Currently, about 17% of US children are presenting with obesity.

8. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2822791

Intermittent Energy Restriction for Adolescents With Obesity In this randomized clinical trial of 141 adolescents with obesity, no differences were found in improvements in body composition or cardiometabolic health.