Clinical trial NCT03674944: FRESH-TEEN: Families Responsibility Education Support Health for Teens
Official title: Targeting Emotional Eating and Weight Loss in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Overweight
Obesity
Overeating
Treatment
Body Mass Index
Intervention
Behavioral Treatment
Dialectical Behavior Therapy
Emotion Regulation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-09-18
Enrollment: 332
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Adolescent weight loss as measured by BMI, BMIz
timeFrame: Change from baseline to month 3, 6, 12, and 18.
measure: Emotion Regulation Skills as measured by Ecological Momentary Assessment using State Difficulties in Emotion Regulation and International Positive and Negative Affect Schedule- Short form
timeFrame: Change from baseline to month 3, 6, 12, and 18.
measure: Emotional Eating as measured by Emotional Eating Scale for children (EES-C)
timeFrame: Change from baseline to month 3, 6, 12, and 18.
Secondary outcomes:
measure: Parent BMI as measured by height and weight
timeFrame: Change from baseline to month 3, 6, 12, and 18.
measure: Parent emotion regulation measured by Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Change from baseline to month 3, 6, 12, and 18.
measure: Parent emotional eating as measured by Emotional Eating Scale (EES)
timeFrame: Change from baseline to month 3, 6, 12, and 18.
measure: Parent-adolescent relationship as measured by using: Inventory of Parents and Peer Attachment and Parental bonding assessment
timeFrame: Change from baseline to month 3, 6, 12, and 18.
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Center for Healthy Eating and Activity Research (CHEAR)
state: California
city: Minneapolis
country: United States
facility: Ambulatory Research Center - University of Minnesota
state: Minnesota
Study officials:
affiliation: UCSD
name: Kerri Boutelle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: