FRESH-TEEN: Families Responsibility Education Support Health for Teens

University of California San Diego

Status: Completed

Conditions: Overweight and Obesity

Treatments: Behavioral: Behavioral Weight Loss (BWL) + Emotion Regulation (ER); Behavioral: Behavioral Weight Loss (BWL)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03674944

180417

R01DK116616 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 332 patients

Sex: All

Ages: 13 to 16 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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332 participants in 2 patient groups

Behavioral Weight Loss (BWL) + Emotion Regulation (ER)

Experimental group

Description:

This program includes: 1) Dialectical Behavior Therapy (DBT) skills 2) Behavioral coaching 3) Emotional Focused Parent Training (EFPT) 4) Behavioral Weight Loss (BWL) skills.

Treatment:

Behavioral: Behavioral Weight Loss (BWL)

Behavioral: Behavioral Weight Loss (BWL) + Emotion Regulation (ER)

Behavioral Weight Loss (BWL)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Behavioral Weight Loss (BWL)