Behavioral Treatments for Childhood Obesity
(FRESH-FR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The objective of this proposed study is to compare Regulation of Cues (ROC), Family-Based Treatment (FBT), ROC+ nutrition education and reducing energy intake (ROC+) and a health education comparator (HE) for children with overweight or obesity who are high on food responsiveness (FR).
Will I have to stop taking my current medications?
The trial requires that children and parents be on a stable medication regimen for medications that can impact weight for at least 3 months, so you likely won't need to stop taking your current medications if they meet this condition.
Is family-based behavioral treatment (FBT) for childhood obesity safe for humans?
How is the Family Based Behavioral Treatment for childhood obesity different from other treatments?
Family Based Behavioral Treatment (FBT) for childhood obesity is unique because it involves both children and their parents in the treatment process, focusing on nutrition, physical activity, and behavior therapy. The treatment's success is often linked to parent weight loss, highlighting the importance of family involvement in achieving better weight loss outcomes for children.678910
What data supports the effectiveness of the treatment Family Based Behavioral Treatment for childhood obesity?
Research shows that family-based behavioral treatment (FBT) is effective for childhood obesity, with successful outcomes linked to both child and parent weight loss. Key factors include targeting both child and parent behaviors, self-monitoring, and family involvement in dietary and physical activity changes.2691112
Who Is on the Research Team?
Kerri Boutelle, Ph.D.
Principal Investigator
UC San Diego
Are You a Good Fit for This Trial?
This trial is for children aged 7-12 with obesity who are very responsive to food. They must be in stable health, able to do physical activities, and not on any new medications for the past 3 months. A parent involved in meal prep must join too, speaking English at least at a 5th-grade level.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly individual sessions for the first 16 sessions, then twice per month for the final 2 months, totaling 20 sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Family Based Behavioral Treatment
- Health Education
- Regulation of Cues
- Regulation of Cues +
Family Based Behavioral Treatment is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Minnesota
Collaborator