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FRESH-TEEN: Families Responsibility Education Support Health for Teens

Targeting Emotional Eating and Weight Loss in Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03674944
Acronym
FRESH-TEEN
Enrollment
332
Registered
2018-09-18
Start date
2019-09-16
Completion date
2024-01-04
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

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

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.

Interventions

BEHAVIORALBehavioral 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).

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

University of Minnesota
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to 16 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Adolescent weight loss as measured by BMI, BMIzChange 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 formChange 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

MeasureTime frame
Parent BMI as measured by height and weightChange 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 assessmentChange 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026