FRESH-TEEN: Families Responsibility Education Support Health for Teens
NCT03674944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332
Last updated 2024-09-24
Summary
The objective of this proposed study is to collect initial efficacy data on a behavioral weight loss (BWL) program for teens, which also includes emotion regulation strategies (ER), to standard BWL.
Conditions
- Overweight and Obesity
Interventions
- BEHAVIORAL
-
Behavioral Weight Loss (BWL) + Emotion Regulation (ER)
The BWL + ER program will teach Dialectical Behavior Therapy (DBT) skills (dialectical abstinence, emotion regulation skills, mindfulness, and distress tolerance) to the adolescent and parent group sessions. Parents are expected to model skill usage and DBT language with their teen to reinforce the skills at home. Adolescents and parents will track emotions and DBT skills used in diary cards which will be provided. Emotion-Focused Parent Training (EFPT) will be provided to the parents at each session to train the parent to support the adolescent in processing emotions, increasing parental emotion self-efficacy, promoting positive parent-adolescent relationships, and reducing the need for dysfunctional emotion regulation behaviors.Behavior coaching will be provided to the adolescent and parent to encourage compliance and review skills after each session (DBT or BWL).
- BEHAVIORAL
-
Behavioral Weight Loss (BWL)
All participants will be instructed to consume an energy restricted diet based on initial body weight. Participants will be instructed to record and self-monitor their food intake. The physical activity component will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations will include: self-monitoring, goal setting, managing high-risk situations, and relapse prevention. Parenting skills will be discussed during parent group sessions which will encourage parents to adopt authoritative parenting styles with regard to eating and exercise behaviors. Parents will also learn about behavioral modification principles, including modeling, reinforcement, and operant conditioning. Behavior coaching will be provided to the adolescent and parent after each session to encourage compliance, discuss completed homework, review habit books to praise efforts and give feedback for areas of improvement.
Sponsors & Collaborators
- collaborator OTHER
-
National Institutes of Health (NIH)
collaborator NIH -
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH -
University of California, San Diego
lead OTHER
Principal Investigators
-
Kerri Boutelle, Ph.D. · UCSD
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-16
- Primary Completion
- 2023-12-12
- Completion
- 2024-01-04
Countries
- United States
Study Locations
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