Family, Responsibility, Education, Support, and Health for Food Responsiveness

Last updated: May 6, 2025
Sponsor: University of California, San Diego
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Family Based Behavioral Treatment

Regulation of Cues

Regulation of Cues +

Clinical Study ID

NCT06207110
806055
1R01DK135599
  • Ages 7-12
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 theCEBQ, 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 canread, 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 physicalactivity for the duration of the study. Parent can participate in physical activitywith their child or provide opportunities for the child to complete recommendedphysical activity

Exclusion

Exclusion Criteria:

  1. Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recenthospitalization, psychosis, bulimia nervosa)

  2. Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1diabetes) for which physician supervision of diet and exercise prescription may bewarranted

  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 severealcohol 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.

Study Design

Total Participants: 280
Treatment Group(s): 4
Primary Treatment: Family Based Behavioral Treatment
Phase:
Study Start date:
April 03, 2024
Estimated Completion Date:
January 01, 2029

Study Description

The investigators have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Behavioral Susceptibility Theory. The ROC program targets two theorized mechanisms for overeating; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. Considering that FBT has merit for some children, but not all, this study will compare ROC to FBT, ROC with nutrition education and reducing energy intake (ROC+), and Health Education (HE). Treatment will consist of weekly individual sessions for the first 16 sessions, then twice per month for the final 2 months for a total of 20 sessions. The investigators will recruit children ages 7-12 with overweight or obesity who are high in food responsiveness (FR) and their parent and will conduct assessments at baseline, post-treatment (month 6), 6-month follow-up (month 12) and 12-month follow-up (month 18).

Connect with a study center

  • UC San Diego Center for Healthy Eating and Activity Research (CHEAR)

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Ambulatory Research Center - University of Minnesota

    Minneapolis, Minnesota 55454
    United States

    Active - Recruiting

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