Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674944
Recruitment Status : Active, not recruiting
First Posted : September 18, 2018
Last Update Posted : March 14, 2022
Sponsor:
Collaborators:
University of Minnesota
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kerri Boutelle, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE August 22, 2018
First Posted Date  ICMJE September 18, 2018
Last Update Posted Date March 14, 2022
Actual Study Start Date  ICMJE September 16, 2019
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • Adolescent weight loss as measured by BMI, BMIz [ Time Frame: 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 [ Time Frame: Change from baseline to month 3, 6, 12, and 18. ]
  • Emotional Eating as measured by Emotional Eating Scale for children (EES-C) [ Time Frame: Change from baseline to month 3, 6, 12, and 18. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • Parent BMI as measured by height and weight [ Time Frame: Change from baseline to month 3, 6, 12, and 18. ]
  • Parent emotion regulation measured by Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Change from baseline to month 3, 6, 12, and 18. ]
  • Parent emotional eating as measured by Emotional Eating Scale (EES) [ Time Frame: 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 [ Time Frame: Change from baseline to month 3, 6, 12, and 18. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FRESH-TEEN: Families Responsibility Education Support Health for Teens
Official Title  ICMJE Targeting Emotional Eating and Weight Loss in Adolescents
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Overweight and Obesity
Intervention  ICMJE
  • Behavioral: Behavioral 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).
  • Behavioral: Behavioral Weight Loss (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.
    Other Name: BWL
Study Arms  ICMJE
  • Experimental: Behavioral Weight Loss (BWL) + Emotion Regulation (ER)
    This program includes: 1) Dialectical Behavior Therapy (DBT) skills 2) Behavioral coaching 3) Emotional Focused Parent Training (EFPT) 4) Behavioral Weight Loss (BWL) skills.
    Interventions:
    • Behavioral: Behavioral Weight Loss (BWL) + Emotion Regulation (ER)
    • Behavioral: Behavioral Weight Loss (BWL)
  • Active Comparator: Behavioral Weight Loss (BWL)
    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.
    Intervention: Behavioral: Behavioral Weight Loss (BWL)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 11, 2022)
332
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2018)
320
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03674944
Other Study ID Numbers  ICMJE 180417
R01DK116616 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kerri Boutelle, University of California, San Diego
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Diego
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Minnesota
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Kerri Boutelle, Ph.D. UCSD
PRS Account University of California, San Diego
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP