Clinical trial NCT03393221: Improving Emotion Regulation Skills Among Adolescents Attempting to Lose Weight
Official title: Enhancing Emotion Regulation Among Overweight and Obese Adolescents Attempting to Lose Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 41
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: While the prevalence of overweight and obesity among children and adolescents has plateaued, national data indicate that approximately 35% of children and adolescents continue to struggle with overweight/obesity. While considerable attention has been given to comprehensive behavioral interventions to address obesity in children, there is less empirical evidence demonstrating efficacy of interventions with adolescents. Additionally, there is great variability and limited impact of adolescent weight control interventions which may be attributable to the failure of these interventions to explicitly address emotion regulation abilities that are necessary for weight loss. Notably, adolescents with poorer general emotion regulation have been found to consume more snack/junk food and report greater amounts of sedentary behavior. Poor emotion regulation among adolescents has also been associated with more rapid weight gain and greater BMI. This project adapts a previously validated Emotion Regulation intervention (TRAC) for at-risk adolescents, targeting sexual risk reduction, to focus on weight loss among a sample of overweight and obese adolescents (ages 12 to 18). While sexual risk and weight management are distinct health behaviors, this same model of emotion regulation could be applied to overweight/obese adolescents attempting to lose weight. In fact, data from overweight/obese adolescents attending a past outpatient weight management program (N=124) indicate that 82% of these youth report emotion regulation scores that are comparable to youth with significant mental health problems. Furthermore, higher levels of emotional dysregulation was associated with greater BMI within this same sample. These data suggest that emotion regulation is related to health decision making and will be relevant to the majority of overweight/obese adolescents seeking to lose weight. The current study will be carried out across Phase 1a and 1b. During Phase 1a, the initial acceptability and feasibility of the adapted intervention (HEALTH TRAC) with eight adolescents in an open pilot trial will be evaluated. During Phase 1b, 48 adolescents between the ages of 13-17 years will be randomized to receive either the HEALTH TRAC or standard behavioral weight control intervention (SBWC) and examine the impact on emotion regulation abilities and BMI status over an eight-month period. The information gained in this project will improve understanding of strategies to improve weight loss outcomes among overweight/obsess adolescents and how improving emotion regulation abilities can enhance these interventions.


Eligibility criteria: Inclusion Criteria:

* 13-17 years of age
* \> 85th percentile for BMI but \< a BMI of 50
* speak English
* agree to participation and randomization

Exclusion Criteria:

* they are currently in another weight loss program
* have a medical condition that precludes participation in physical activity or adherence to dietary recommendations
* are developmentally delayed such that the intervention will not be appropriate
* are in treatment for a major psychiatric disorder.
* cannot understand English

Primary outcomes:
measure: BMI decrease
timeFrame: baseline, 4 months, and 8 month follow up
Secondary outcomes:
measure: Emotion Regulation
timeFrame: baseline, 4 month, and 8 month follow up
measure: Emotion Regulation Strategy Usage
timeFrame: baseline, 4 month, and 8 month follow up
measure: Emotion Regulation
timeFrame: baseline, 4 month, and 8 month follow up
measure: Emotion Regulation
timeFrame: baseline, 4 month, and 8 month follow up
measure: Distress Tolerance
timeFrame: baseline and 4 months
measure: Emotion Regulation
timeFrame: baseline, 4 month, and 8 month follow up
measure: Emotion Regulation
timeFrame: baseline, 4 month, and 8 month follow up
measure: Emotional Eating
timeFrame: baseline, 4 month, and 8 month follow up
measure: Eating Disorders
timeFrame: baseline, 4 month, and 8 month follow up
measure: Eating Habits Confidence
timeFrame: baseline to 8 months
measure: Eating Behavior
timeFrame: baseline, 4 months, and 8 months
measure: Accelerometer (physical activity)
timeFrame: baseline and 4 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Coro Building
state: Rhode Island
Study officials:
affiliation: University of Oregon
name: Wendy Hadley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hadley W, Houck C, Barker D, Wickham B, Bogner J, Jelalian E. Preliminary Impact of an Adapted Emotion Regulation Intervention for Adolescents with Overweight and Obesity Attempting to Lose Weight. J Dev Behav Pediatr. 2020 Dec;41(9):706-715. doi: 10.1097/DBP.0000000000000837.