Emotional Management Intervention for Teen Obesity
(HealthTRAC Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byElissa Jelalian, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: The Miriam Hospital
No Placebo Group
Trial Summary
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.
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.
12345What 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.
14678Eligibility Criteria
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
Speak English due to the group format of the intervention
Agree to study participation, measures, and randomization
I am between 13 and 17 years old.
+3 more
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.
+2 more
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
University of OregonEugene, OR
Oregon Health & Science UniversityPortland, OR
The Miriam HospitalProvidence, RI
Loading ...
Who Is Running the Clinical Trial?
The Miriam HospitalLead Sponsor
Oregon Health and Science UniversityCollaborator
Rhode Island HospitalCollaborator
University of OregonCollaborator
References
Preliminary Impact of an Adapted Emotion Regulation Intervention for Adolescents with Overweight and Obesity Attempting to Lose Weight. [2022]This study examines the acceptability, feasibility, and preliminary impact of a program (HealthTRAC) combining 2 efficacious interventions (one targeting emotion regulation [TRAC] and the other a standardized behavioral weight management intervention [SBWC]) to improve weight management outcomes among a sample of adolescents with overweight and obesity.
A cognitive behavioral therapy program for overweight children. [2018]To assess the 1-year results of a multidisciplinary, cognitive behavioral therapy treatment program for overweight and obese children.
Parental obesity and higher pre-intervention BMI reduce the likelihood of a multidisciplinary childhood obesity program to succeed--a clinical observation. [2022]To assess the effects and identify factors associated with success of a combined, structured multidisciplinary weight management program in obese children and adolescents.
A brief emotion regulation training in children and adolescents with obesity: A feasibility study. [2022]Recent studies emphasize the role of emotion dysregulation as an underlying mechanism initiating and maintaining emotional eating in obesity. Since multidisciplinary obesity treatment (MOT) does not directly address emotion regulation (ER), the current study aimed to investigate the feasibility of an ER training in children and adolescents with obesity on top of MOT. Feasibility was evaluated multi-informant on relevant parameters e.g. practicability, satisfaction, change in affect and homework compliance.
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]Though recent data suggest that multidisciplinary outpatient interventions can have a positive effect on childhood obesity, it is still unclear which program components are most beneficial and how they affect quality of life (QoL). The aim of this study was to determine if a 1-year multidisciplinary, family-centered outpatient intervention based on social cognitive theory would be effective in (i) preventing further increases in BMI and BMI z-score, and (ii) improving QoL in obese children and adolescents.
Psychosocial Screening Among Youth Seeking Weight Management Treatment. [2019]The objectives of this study were to identify rates of, and factors associated with, "at-risk" scores on a brief psychosocial screener among overweight/obese youth seeking weight management treatment, as well as concordance between youth and caregiver reports. A retrospective chart review of 1443 consecutive patients ages 4 to 18 years and their caregivers was conducted. Almost 1 in 4 youth with overweight/obesity presented with psychosocial symptoms in the at-risk range for significant mental health issues based on caregiver report on the Pediatric Symptom Checklist (PSC) and 1 in 6 based on youth self-report on the Youth Pediatric Symptom Checklist (Y-PSC). Concordance between caregiver and youth was fair (agreement 24% to 40%). Higher scores were associated with male sex and older age on the PSC and with indication of depressive disorder in the electronic medical record on the Y-PSC. Conducting a brief psychosocial screen in comprehensive weight management programs is feasible and clinically indicated.
Multidisciplinary intervention with sibutramine: assessing successful weight loss predictors in military adolescent dependents. [2019]Assess body mass index (BMI) reduction through a multidisciplinary intervention with sibutramine in adolescents of military parents and examine characteristics and behavioral traits as predictors of successful weight loss.
Emotion regulation training in the treatment of obesity in young adolescents: protocol for a randomized controlled trial. [2020]The prevalence rates of childhood obesity are increasing. The current multidisciplinary treatments for (childhood) obesity are effective but only moderately and in the short term. A possible explanation for the onset and maintenance of childhood obesity is that it reflects a maladaptive mechanism for regulating high levels of stress and emotions. Therefore, the current RCT study aims to test the effectiveness of adding an emotion regulation training to care as usual (multidisciplinary obesity treatment) in young inpatients (10-14) involved in an obesity treatment program compared to care as usual alone. The research model for this RCT study states that when high levels of stress are regulated in a maladaptive way, this can contribute to the development of obesity.
Treatment Effects on Psychophysiological Stress Responses in Youth With Obesity. [2023]Stress plays a central role in obesity development, but research on treatment options to tackle elevated stress levels in youth with obesity is scarce. The present study examined the impact of the Multidisciplinary Obesity Treatment (MOT; lifestyle intervention including physical exercise, healthy meals, and cognitive behavioral techniques) on physiological stress parameters in youth with obesity and assessed whether adding emotion regulation (ER) training on top of MOT is beneficial.
Emotional processing in obesity: a systematic review and exploratory meta-analysis. [2018]The role of emotional functioning in the development and maintenance of obesity has been investigated, but the literature is poorly integrated. A systematic review and meta-analysis was performed to explore emotional processing impairments in obesity. PubMed, Web of Knowledge and PsycINFO databases were searched in March 2016, yielding 31 studies comparing emotional processing competencies in individuals with obesity, with or without binge eating disorder (BED), and control groups. Meta-analyses demonstrated that individuals with obesity had higher scores of alexithymia (d = 0.53), difficulty in identifying feelings (d = 0.34) and externally oriented thinking style (d = 0.31), when compared with control groups. On other competencies, patients with obesity, especially those with comorbid BED, reported lower levels of emotional awareness and difficulty in using emotion regulation strategies, namely, reduced cognitive reappraisal and acceptance, and greater suppression of expression. No evidence of impaired ability to recognize emotions in others or verbally express emotions was found. A general emotion-processing deficit in obesity was not supported. Instead, an emotional avoidance style may occur modulating later responses of emotion regulation. Additional research is needed to extend the comprehension of these conclusions and the role of BED in emotional functioning in obesity.