FRESH-TEEN: Families Responsibility Education Support Health for Teens

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Behavioral: Behavioral Weight Loss (BWL); Behavioral: Behavioral Weight Loss (BWL) + Emotion Regulation (ER)

• Registration Number: NCT03674944
• Lead Sponsor: University of California, San Diego

Brief 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.

Detailed Description

The study will compare the efficacy of BWL + ER and BWL. Investigators will provide 6 months of treatment (BWL + ER or BWL) and will follow participants at 12-months post-treatment (total time = 18 months). Investigators will recruit adolescents with overweight and obesity and their parents. Dyads will be assessed at 5 timepoints: baseline (2 visits), mid-treatment (1 visit), post-treatment (2 visits), 6-month follow-up (2 visits), and 12-month follow-up (2 visits). Assessments will include the following for the adolescent and parent: anthropometry, emotion regulation, emotional inhibition, emotional eating, and adolescent-parent relationship measures. This program of research has the potential to advance the standard of practice for adolescents who are overweight or obese by providing alternative interventions.

We are currently offering online treatment groups to accommodate the CDC health and safety guidelines.

Study Timeline

• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-18
• Study Start: 2019-09-16
• Primary Completion: 2023-12-12
• Study Completion: 2024-01-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

• Adolescent age 13-16 years
• BMI percentile 85%85%-99.9% (adolescent only)
• Ability to read English at a minimum 6th grade level (both adolescent and parent); and willing to participate in a 6-month treatment and all assessments (both adolescent and parent)

Exclusion Criteria

1. Current enrollment in a weight management program (Child and Parent);
2. Medication that is specifically prescribed for weight loss (Child and Parent);
3. Medical or psychiatric condition that may interfere with treatment participation (Child and Parent);
4. Regular use of compensatory behavior for weight loss (e.g., purging) during the past six months (Child and Parent);
5. Current pregnancy or lactating (Child and Parent);
6. Change in psychotropic medication during the previous three months (Child and Parent).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Weight Loss (BWL)	Behavioral Weight Loss (BWL)	This program includes information about diet and physical activity education, in addition to parent management skills, and behavioral modification principles including: modeling, reinforcement, and operant conditioning.
Behavioral Weight Loss (BWL) + Emotion Regulation (ER)	Behavioral Weight Loss (BWL) + Emotion Regulation (ER)	This program includes: 1) Dialectical Behavior Therapy (DBT) skills 2) Behavioral coaching 3) Emotional Focused Parent Training (EFPT) 4) Behavioral Weight Loss (BWL) skills.
Behavioral Weight Loss (BWL) + Emotion Regulation (ER)	Behavioral Weight Loss (BWL)	This program includes: 1) Dialectical Behavior Therapy (DBT) skills 2) Behavioral coaching 3) Emotional Focused Parent Training (EFPT) 4) Behavioral Weight Loss (BWL) skills.

Primary Outcome Measures

Name	Time	Method
Emotional Eating as measured by Emotional Eating Scale for children (EES-C)	Change from baseline to month 3, 6, 12, and 18.
Adolescent weight loss as measured by BMI, BMIz	Change from baseline to month 3, 6, 12, and 18.
Emotion Regulation Skills as measured by Ecological Momentary Assessment using State Difficulties in Emotion Regulation and International Positive and Negative Affect Schedule- Short form	Change from baseline to month 3, 6, 12, and 18.

Secondary Outcome Measures

Name	Time	Method
Parent-adolescent relationship as measured by using: Inventory of Parents and Peer Attachment and Parental bonding assessment	Change from baseline to month 3, 6, 12, and 18.
Parent BMI as measured by height and weight	Change from baseline to month 3, 6, 12, and 18.
Parent emotion regulation measured by Difficulties in Emotion Regulation Scale (DERS)	Change from baseline to month 3, 6, 12, and 18.
Parent emotional eating as measured by Emotional Eating Scale (EES)	Change from baseline to month 3, 6, 12, and 18.

Trial Locations

Locations (2)

UCSD Center for Healthy Eating and Activity Research (CHEAR); 🇺🇸 La Jolla, California, United States

Ambulatory Research Center - University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States