Emotional Management Intervention for Teen Obesity

(HealthTRAC Trial)

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

172 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

What safety data exists for the Emotional Management Intervention for Teen Obesity?

The available research indicates that the Emotional Management Intervention, also known as HealthTRAC or SBWC, has been evaluated for its feasibility and acceptability. Studies have focused on combining emotion regulation with behavioral weight management to improve outcomes. While specific safety data is not detailed, the intervention's feasibility and acceptability suggest it is considered safe for use in adolescents with obesity. Additionally, psychosocial screening is recommended in weight management programs to identify mental health risks, which implies a consideration of safety in these interventions. ^{1 2 3 4 5}

Is the Emotional Management Intervention for Teen Obesity safe for humans?

The studies suggest that the Emotional Management Intervention, including programs like HealthTRAC and SBWC, is generally safe for adolescents with obesity. The research focuses on feasibility and acceptability, indicating that the intervention is well-received and practical for participants. ^{1 2 3 4 5}

Is HealthTRAC a promising treatment for teen obesity?

Yes, HealthTRAC is a promising treatment for teen obesity. It combines emotion regulation and weight management strategies, which can help teens manage their emotions better and improve their weight management outcomes. ^{1 3 5 6 7}

How is the treatment HealthTRAC different from other treatments for teen obesity?

HealthTRAC is unique because it combines emotion regulation training with a standard behavioral weight management program, addressing both emotional and behavioral aspects of obesity, which are often not targeted together in traditional treatments. ^{1 3 5 6 7}

What data supports the idea that Emotional Management Intervention for Teen Obesity is an effective treatment?

The available research shows that the Emotional Management Intervention, known as HealthTRAC, combines emotion regulation and behavioral weight management strategies. This combination has been found to improve weight management outcomes in teens with obesity. While other treatments like cognitive behavioral therapy and multidisciplinary programs also aim to help with weight loss, HealthTRAC specifically targets emotional regulation, which is important because emotional eating can contribute to obesity. This focus on emotions may make HealthTRAC more effective for some teens compared to treatments that do not address emotional factors. ^{1 3 8 9 10}

What data supports the effectiveness of the treatment HealthTRAC, SBWC, and Standard Behavioral Weight Control for teen obesity?

Research shows that combining emotion regulation training with standard weight management programs can help improve weight management outcomes in teens with obesity. This approach addresses emotional eating, which is a common challenge in managing obesity. ^{1 3 8 9 10}

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 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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Preliminary Impact of an Adapted Emotion Regulation Intervention for Adolescents with Overweight and Obesity Attempting to Lose Weight. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A cognitive behavioral therapy program for overweight children. [2018]

3. Germany 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. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A brief emotion regulation training in children and adolescents with obesity: A feasibility study. [2022]

5. England 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. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Psychosocial Screening Among Youth Seeking Weight Management Treatment. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Multidisciplinary intervention with sibutramine: assessing successful weight loss predictors in military adolescent dependents. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Emotion regulation training in the treatment of obesity in young adolescents: protocol for a randomized controlled trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Treatment Effects on Psychophysiological Stress Responses in Youth With Obesity. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Emotional processing in obesity: a systematic review and exploratory meta-analysis. [2018]