Family, Responsibility, Education, Support, and Health for Food Responsiveness
NCT ID: NCT06207110
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
280 participants
INTERVENTIONAL
2024-04-03
2029-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Regulation of Cues
The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning targeting increasing satiety responsiveness and decreasing food cue responsiveness.
Regulation of Cues
ROC is based on the Behavioral Susceptibility Theory and designed to incorporate psychoeducation, cue-exposure treatment, appetite awareness training, coping skills, and self-monitoring of satiety and cravings to improve satiety responsiveness and decrease food cue responsiveness. This arm will include an experiential component, including hunger monitoring during a meal or snack and participating in exposure exercises.
Family-Based Treatment
The FBT program provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
Family Based Behavioral Treatment
FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
Regulation of Cues +
The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake
Regulation of Cues +
ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake
Health Education
The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
Health Education
The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
Interventions
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Regulation of Cues
ROC is based on the Behavioral Susceptibility Theory and designed to incorporate psychoeducation, cue-exposure treatment, appetite awareness training, coping skills, and self-monitoring of satiety and cravings to improve satiety responsiveness and decrease food cue responsiveness. This arm will include an experiential component, including hunger monitoring during a meal or snack and participating in exposure exercises.
Family Based Behavioral Treatment
FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
Regulation of Cues +
ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake
Health Education
The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
7 Years
12 Years
ALL
Yes
Sponsors
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University of Minnesota
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of California, San Diego
OTHER
Responsible Party
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Kerri Boutelle
Kerri Boutelle, Ph.D.,, Professor of Pediatrics, Psychiatry, and Herbert Wertheim School of Public Health and Human Longevity Science
Principal Investigators
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Kerri Boutelle, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
UC San Diego
Locations
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UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, United States
Ambulatory Research Center - University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Learn more on our study webpage
Other Identifiers
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806055
Identifier Type: -
Identifier Source: org_study_id
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