Comparing different treatments for childhood obesity and food responsiveness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of various interventions for children aged 7-12 with overweight or obesity who exhibit high food responsiveness. The interventions include a new model called Regulation of Cues (ROC), Family-Based Treatment (FBT), a combination of ROC with nutrition education and energy intake reduction (ROC+), and a health education comparator (HE). Participants will attend weekly sessions for the first 16 weeks, followed by bi-monthly sessions for an additional two months, with assessments conducted at multiple time points throughout the study. The goal is to determine which approach is most effective in managing overeating behaviors and improving weight outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Informed assent and parental consent
2. A child with overweight or obesity (≥ 85th BMI%) aged 7-12 years of age
3. 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.
4. 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
5. Family is willing to commit to attending all assessment and treatment sessions, agree to be randomized and participate in all aspects of potential treatments
6. Child is on stable medication regimen for medications that can impact weight (3+ months)
7. 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

Exclusion Criteria:

1. Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recent hospitalization, psychosis, bulimia nervosa)
2. Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and exercise prescription may be warranted
3. Child who is taking medication for weight loss
4. Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar disorder, borderline personality disorder, moderate or severe alcohol or substance use disorder)
5. First degree relative or someone in the household with anorexia or bulimia nervosa.

Potential participants with medical or psychological diagnosis that could make adherence with the study protocol difficult or dangerous will not be included.

Where it's running

• UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
  La Jolla, California, United States Recruiting
• Ambulatory Research Center - University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Kerri Boutelle, Ph.D. — UC San Diego
• Study coordinator: Kaylen Moline, MPH
• Email: chear@ucsd.edu
• Phone: 1-855-827-3498

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.