Obesity in Children Clinical Trials

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Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 12
Healthy Volunteers: t
View:

• Informed assent and parental consent

• A child with overweight or obesity (≥ 85th BMI%) aged 7-12 years of age

• Child high on FR - High FR will be measured by the Food Responsiveness Scale via the CEBQ, with scores at a 3.8 or higher constituting a child with high FR.

• A parent responsible for food preparation who is willing to participate and can read, speak and understand English at a minimum of a 5th grade level

• Family is willing to commit to attending all assessment and treatment sessions, agree to be randomized and participate in all aspects of potential treatments

• Child is on stable medication regimen for medications that can impact weight (3+ months)

• Child does not have medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity with their child or provide opportunities for the child to complete recommended physical activity

Locations
United States
California
UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
RECRUITING
La Jolla
Minnesota
Ambulatory Research Center - University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Kaylen Moline, MPH
chear@ucsd.edu
1-855-827-3498
Backup
Kerri Boutelle, Ph.D.
kboutelle@ucsd.edu
858-249-3528
Time Frame
Start Date: 2024-04-03
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 280
Treatments
Experimental: Regulation of Cues
The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning targeting increasing satiety responsiveness and decreasing food cue responsiveness.
Active_comparator: Family-Based Treatment
The FBT program provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
Experimental: Regulation of Cues +
The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake
Active_comparator: Health Education
The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Minnesota
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov