FRESH-TEEN: Families Responsibility Education Support Health for Teens

NCT03674944 | Completed

• 2 other identifiers: 180417R01DK116616
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight and Obesity

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

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

  Change from baseline to month 3, 6, 12, and 18.

Secondary Outcomes (4)

• 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.

• 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.

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral Weight Loss (BWL)

ACTIVE COMPARATOR

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: Behavioral Weight Loss (BWL)

Interventions

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

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 Weight Loss (BWL) + Emotion Regulation (ER)

Behavioral Weight Loss (BWL) BEHAVIORAL

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.

Also known as: BWL

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

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Diego: lead
• University of Minnesota: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92037, United States

Location

Ambulatory Research Center - University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

• Boutelle KN, Manzano MA, Pasquale EK, Bernard RS, Strong DR, Rhee KE, Eichen DM, Engel S, Miller A, Peterson CB. Design of the FRESH-teen study: A randomized controlled trial evaluating an adapted emotion regulation weight loss program for adolescents with overweight or obesity and their parent. Contemp Clin Trials. 2024 Oct;145:107640. doi: 10.1016/j.cct.2024.107640. Epub 2024 Jul 28.

  PMID: 39079614 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Hyperphagia; Emotional Regulation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Self-Control; Social Behavior; Behavior

Study Officials

• Kerri Boutelle, Ph.D.

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kerri Boutelle, Ph.D., Professor, Departments of Pediatrics and Psychiatry

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: September 18, 2018
• Study Start: September 16, 2019
• Primary Completion: December 12, 2023
• Study Completion: January 4, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)