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FRESH-TEEN: Families Responsibility Education Support Health for Teens (FRESH-TEEN)

Primary Purpose

Overweight and Obesity

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Behavioral Weight Loss (BWL)

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Overweight, Obesity, Overeating, Treatment, Body Mass Index, Intervention, Behavioral Treatment, Dialectical Behavior Therapy, Emotion Regulation

Eligibility Criteria

13 Years - 16 Years (Child)All SexesDoes not accept 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:

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

Sites / Locations

UCSD Center for Healthy Eating and Activity Research (CHEAR)
Ambulatory Research Center - University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Behavioral Weight Loss (BWL)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Adolescent weight loss as measured by BMI, BMIz

Emotion Regulation Skills as measured by Ecological Momentary Assessment using State Difficulties in Emotion Regulation and International Positive and Negative Affect Schedule- Short form

Emotional Eating as measured by Emotional Eating Scale for children (EES-C)

Secondary Outcome Measures

Parent BMI as measured by height and weight

Parent emotion regulation measured by Difficulties in Emotion Regulation Scale (DERS)

Parent emotional eating as measured by Emotional Eating Scale (EES)

Parent-adolescent relationship as measured by using: Inventory of Parents and Peer Attachment and Parental bonding assessment

Full Information

NCT ID

NCT03674944

First Posted

August 22, 2018

Last Updated

March 29, 2023

Sponsor

University of California, San Diego

Collaborators

University of Minnesota, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT03674944

Brief Title

FRESH-TEEN: Families Responsibility Education Support Health for Teens

Acronym

FRESH-TEEN

Official Title

Targeting Emotional Eating and Weight Loss in Adolescents

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 16, 2019 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

University of Minnesota, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity

Keywords

Overweight, Obesity, Overeating, Treatment, Body Mass Index, Intervention, Behavioral Treatment, Dialectical Behavior Therapy, Emotion Regulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

332 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm 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.

Arm Title

Behavioral Weight Loss (BWL)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Weight Loss (BWL)

Other Intervention Name(s)

BWL

Intervention Description

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.

Primary Outcome Measure Information:

Title

Adolescent weight loss as measured by BMI, BMIz

Time Frame