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Behavioural Intervention

Behavioral Weight Loss + Emotion Regulation for Obesity (FRESH-TEEN Trial)

N/A
Waitlist Available
Led By Kerri Boutelle, Ph.D.
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adolescent age 13-16 years
Adolescent age 13-16 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to month 3, 6, 12, and 18.
Awards & highlights

FRESH-TEEN Trial Summary

This trial will compare a weight loss program that includes emotion regulation strategies to a standard weight loss program, to see if the addition of emotion regulation makes the program more effective.

Who is the study for?
The FRESH-TEEN trial is for teens aged 13-16 with obesity, defined as having a BMI percentile between 85% and 99.9%. Both the teen and their parent must read English at least at a 6th-grade level and be willing to engage in a 6-month treatment program. Those already in weight management programs or using certain medications are excluded.Check my eligibility
What is being tested?
This study tests a Behavioral Weight Loss (BWL) program that includes Emotion Regulation (ER) strategies against standard BWL alone. The goal is to see if adding ER can improve outcomes for obese adolescents over the course of six months.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medication, traditional side effects like those seen with drugs are not expected. However, participants may experience emotional discomfort or stress related to lifestyle changes.

FRESH-TEEN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 13 and 16 years old.
Select...
I am between 13 and 16 years old.

FRESH-TEEN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to month 3, 6, 12, and 18.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to month 3, 6, 12, and 18. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adolescent weight loss as measured by BMI, BMIz
Emotion Regulation Skills as measured by Ecological Momentary Assessment using State Difficulties in Emotion Regulation and International Positive and Negative Affect Schedule- Short form
Emotional Eating as measured by Emotional Eating Scale for children (EES-C)
Secondary outcome measures
Parent BMI as measured by height and weight
Parent emotion regulation measured by Difficulties in Emotion Regulation Scale (DERS)
Parent emotional eating as measured by Emotional Eating Scale (EES)
+1 more

FRESH-TEEN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral Weight Loss (BWL) + Emotion Regulation (ER)Experimental Treatment2 Interventions
This program includes: 1) Dialectical Behavior Therapy (DBT) skills 2) Behavioral coaching 3) Emotional Focused Parent Training (EFPT) 4) Behavioral Weight Loss (BWL) skills.
Group II: Behavioral Weight Loss (BWL)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Weight Loss (BWL)
2016
Completed Phase 3
~790

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,114 Previous Clinical Trials
1,519,548 Total Patients Enrolled
53 Trials studying Obesity
7,482 Patients Enrolled for Obesity
University of MinnesotaOTHER
1,367 Previous Clinical Trials
1,587,177 Total Patients Enrolled
70 Trials studying Obesity
20,717 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,350 Total Patients Enrolled
102 Trials studying Obesity
25,720 Patients Enrolled for Obesity

Media Library

Behavioral Weight Loss (BWL) + Emotion Regulation (ER) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03674944 — N/A
Obesity Research Study Groups: Behavioral Weight Loss (BWL) + Emotion Regulation (ER), Behavioral Weight Loss (BWL)
Obesity Clinical Trial 2023: Behavioral Weight Loss (BWL) + Emotion Regulation (ER) Highlights & Side Effects. Trial Name: NCT03674944 — N/A
Behavioral Weight Loss (BWL) + Emotion Regulation (ER) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03674944 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals included in the recruitment process for this research?

"Per the regulations of this trial, allowable participants must be between 13 and 16 years old."

Answered by AI

Are there available spots still open for enrolment in this clinical trial?

"As detailed on clinicaltrials.gov, this medical research project is not currently accepting new participants; having been initially posted on September 16th 2019 and last updated on March 11th 2022. Nevertheless, 331 other studies are actively enrolling patients at the moment."

Answered by AI

Does the protocol of this trial permit my participation?

"This scientific inquiry is searching for 332 adolescents between the ages of 13 and 16 who fall within the 85th to 99.9th percentile range on BMI scale. Furthermore, it's a requirement that these participants meet other criteria set out by this trial as well."

Answered by AI

Who else is applying?

How old are they?
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
~60 spots leftby Mar 2025