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Completed

NCT Number: NCT03674944

FRESH-TEEN: Families Responsibility Education Support Health for Teens

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.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Emotional Regulation Hyperphagia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Self-Control Signs and Symptoms Signs and Symptoms, Digestive Social Behavior

Age range

13 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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)

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.

Other names: BWL

Primary outcomes

  1. Adolescent weight loss as measured by BMI, BMIz

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

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

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

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

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

Secondary outcomes

  1. Parent BMI as measured by height and weight

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

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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

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

Registry information

Official study title

Targeting Emotional Eating and Weight Loss in Adolescents

Acronym: FRESH-TEEN

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Sep 18, 2018
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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