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NCT03393221 · ClinicalTrials.gov registry record · NA
Improving Emotion Regulation Skills Among Adolescents Attempting to Lose Weight
A NA study of Overweight and Obesity, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- NA
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT03393221: Completed NA study of Overweight and Obesity, sponsored by Rhode Island Hospital.
NCT03393221 is a NA study of Overweight and Obesity that has completed, run by Rhode Island Hospital. The registered enrollment target is 41 participants, below the 228-participant average among 115 other Overweight and Obesity trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03393221, a NA study of Overweight and Obesity, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study 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 an
Primary Outcome
A significant decrease in participant BMI due to weight loss
Conditions Studied
Interventions
- BEHAVIORAL SBWC
- BEHAVIORAL ER
Study Locations (1)
Rhode Island
- Coro Building - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2016-12 |
| Est. Completion | 2019-07 |
| Phase | NA |
What the finished NCT03393221 record still lists
NCT03393221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 228-participant average among 115 other Overweight and Obesity trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Overweight and Obesity appearing as the primary indexed condition, and to 2 interventions - of which SBWC is the first listed.
NCT03393221 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT03393221 about?
NCT03393221 is a clinical study titled "Improving Emotion Regulation Skills Among Adolescents Attempting to Lose Weight". 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 t...
What is the current status of trial NCT03393221?
This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2016-12. Estimated completion is 2019-07.
What conditions does trial NCT03393221 study?
This clinical trial studies the following conditions: Overweight and Obesity.
What interventions are being tested in trial NCT03393221?
The interventions under investigation include: SBWC (BEHAVIORAL), ER (BEHAVIORAL).
Who is sponsoring clinical trial NCT03393221?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03393221 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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participants (enrollment target), bucketed by value
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