Ignite Creation Date:
2024-05-06 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03393221
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2017-12-11
Brief Title:
Improving Emotion Regulation Skills Among Adolescents Attempting to Lose Weight
Sponsor:
Rhode Island Hospital
Organization:
Rhode Island Hospital
Study Overview
Official Title:
Enhancing Emotion Regulation Among Overweight and Obese Adolescents Attempting to Lose Weight
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 overweightobesity 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 snackjunk 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 overweightobese adolescents attempting to lose weight In fact data from overweightobese adolescents attending a past outpatient weight management program N124 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 overweightobese 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 overweightobsess adolescents and how improving emotion regulation abilities can enhance these interventions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None