Family, Responsibility, Education, Support, and Health for Food Responsiveness
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).
Conditions:
🦠 Obesity, Childhood
🗓️ Study Start (Actual) 3 April 2024
🗓️ Primary Completion (Estimated) 1 January 2029
✅ Study Completion (Estimated) 1 January 2029
👥 Enrollment (Estimated) 280
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 La Jolla, California, United States
📍 Minneapolis, Minnesota, United States

📋 Eligibility Criteria

Description

    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 4 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 and parent 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. Parent is pregnant or planning on becoming pregnant or lactating during the duration of the study
    • 6. 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.
Ages Eligible for Study: 7 Years to 12 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 January 2024
  • First Submitted that Met QC Criteria 5 January 2024
  • First Posted 16 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 May 2024
  • Last Update Posted 21 May 2024
  • Last Verified May 2024