Improving Emotion Regulation Skills Among Adolescents Attempting to Lose Weight

NCT03393221 | Completed

• 1 other identifier: 1R21DK108164-01A1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• BMI decrease

  A significant decrease in participant BMI due to weight loss

  baseline, 4 months, and 8 month follow up

Secondary Outcomes (12)

• Emotion Regulation

  baseline, 4 month, and 8 month follow up

• Emotion Regulation Strategy Usage

  baseline, 4 month, and 8 month follow up

• Emotion Regulation

  baseline, 4 month, and 8 month follow up

• Emotion Regulation

  baseline, 4 month, and 8 month follow up

• Distress Tolerance

  baseline and 4 months

Study Arms (2)

SBWC+ER

EXPERIMENTAL

Participants randomized to the Standard Behavioral Weight Control and Emotional Regulation (SBWC+ER) condition receive a 14-session intervention that is comprised of 12 consecutive weekly sessions and 2 booster sessions delivered at weeks 14 and 16. They receive the same information as the Standard Behavioral Weight Control group, but weekly sessions also include elements of TRAC, and it is designed to help teach emotion regulation skills to decrease overeating and sedentary behaviors and increase the likelihood of maintaining diet and exercise behaviors that are taught as part of SBWC interventions.

Behavioral: ER; Behavioral: SBWC

SBWC

ACTIVE COMPARATOR

Participants randomized to the Standard Behavioral Weight Control (SBWC) condition receive a 14-session intervention that is comprised of 12 consecutive weekly sessions and 2 booster sessions delivered at weeks 14 and 16. The intervention includes a dietary plan, a fitness plan, behavioral weight control management that includes self-monitoring, goal-setting, stimulus control strategies, and planning, as well as parental involvement.

Behavioral: SBWC

Interventions

ER BEHAVIORAL

Emotion regulation content

SBWC+ER

SBWC BEHAVIORAL

SBWC; SBWC+ER

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Coro Building

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• 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.

  PMID: 32740283 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wendy Hadley, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 8, 2018
• Study Start: December 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 19, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)