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

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ClinicalTrials.gov Identifier: NCT03674944
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborators:
University of Minnesota, MN
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

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Behavioral Weight Loss (BWL) + Emotion Regulation (ER) Behavioral: Behavioral Weight Loss (BWL) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting Emotional Eating and Weight Loss in Adolescents
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescent age 13-16 years
  • Under 40.05 BMI
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674944


Contacts
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Contact: Kerri Boutelle, Ph.D. 8585348037 kboutelle@ucsd.edu
Contact: Elena Kaltsas 8585342469 ext 62879 ekaltsas@ucsd.edu

Locations
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United States, California
UCSD Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, United States, 92093
United States, Minnesota
Ambulatory Research Center - University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Carol Peterson, Ph.D.    612-273-9811    peter161@umn.edu   
Sponsors and Collaborators
University of California, San Diego
University of Minnesota, MN
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Kerri Boutelle, Ph.D. UCSD

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Responsible Party: Kerri Boutelle, Kerri Boutelle, Ph.D., Professor, Departments of Pediatrics and Psychiatry, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03674944     History of Changes
Other Study ID Numbers: 180417
R01DK116616 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kerri Boutelle, University of California, San Diego:
Overweight
Obesity
Overeating
Treatment
Body Mass Index
Intervention
Behavioral Treatment
Dialectical Behavior Therapy
Emotion Regulation

Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms