- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06207110
Family, Responsibility, Education, Support, and Health for Food Responsiveness (FRESH-FR)
April 4, 2024 updated by: Kerri Boutelle, University of California, San Diego
Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat
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).
Study Overview
Status
Recruiting
Conditions
Detailed 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).
Study Type
Interventional
Enrollment (Estimated)
280
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kaylen Moline, MPH
- Phone Number: 1-855-827-3498
- Email: chear@ucsd.edu
Study Contact Backup
- Name: Kerri Boutelle, Ph.D.
- Phone Number: 858-249-3528
- Email: kboutelle@ucsd.edu
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- Recruiting
- UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
-
Contact:
- Kaylen Moline, MPH
- Phone Number: 855-827-3498
- Email: chear@health.ucsd.edu
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- Not yet recruiting
- Ambulatory Research Center - University of Minnesota
-
Contact:
- Carol Peterson, Ph.D.
- Phone Number: 612-273-9811
- Email: peter161@umn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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 4 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 and parent 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
Exclusion Criteria:
- Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recent hospitalization, psychosis, bulimia nervosa)
- 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
- Child who is taking medication for weight loss
- Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar disorder, borderline personality disorder, moderate or severe alcohol or substance use disorder)
- Parent is pregnant or planning on becoming pregnant or lactating during the duration of the study
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
|
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.
|
FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
Other Names:
|
Experimental: Regulation of Cues +
The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake
|
ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake
Other Names:
|
Active Comparator: Health Education
The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
|
The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Child Overeating episodes
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
Measured by The Child Eating Disorder Examination (chEDE)
|
Change from baseline at 6 months,12 months, and 18 months
|
Child age and sex adjusted body mass index z-score (BMIz)
Time Frame: Change from baseline at 3 months, 6 months, 12 months, and 18 months
|
Age and sex adjusted body mass index (BMI (kg/m^2)) z-score based on the Centers for for Disease Control and Prevention (CDC) norms
|
Change from baseline at 3 months, 6 months, 12 months, and 18 months
|
Child percentage of the 95th percentile BMI (%BMIp95)
Time Frame: Change from baseline 3 months, 6 months, 12 months, and 18 months
|
Age and Sex specific percentage of the 95th percentile BMI
|
Change from baseline 3 months, 6 months, 12 months, and 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Food Cue Responsiveness as measured by the Child Eating Behavior Questionnaire
Time Frame: Change from baseline at 6 months,12 months, and 18 months]
|
The Food Responsiveness (FR) Scale of the Child Eating Behavior Questionnaire; scores range from 1-5 with higher scores representing greater FR.
|
Change from baseline at 6 months,12 months, and 18 months]
|
Child Food Cue Responsiveness as measured during exposure to a preferred food
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
The child will be asked to hold, smell, and taste the highly craved food and rate their current cravings over the course of 5 minutes.
|
Change from baseline at 6 months,12 months, and 18 months
|
Child Satiety Responsiveness as measured by the Child Eating Behavior Questionnaire
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
The Satiety Responsiveness (SR) scale of the Child Eating Behavior Questionnaire (CEBQ).
Scores range from 1-5 with higher scores representing greater SR.
|
Change from baseline at 6 months,12 months, and 18 months
|
Child Satiety Responsiveness as measured by the Water Load Task (WLT)
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
The Water Load Task
|
Change from baseline at 6 months,12 months, and 18 months
|
Child Inhibition as measured by the Stop Signal Task
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
Stop Signal Task with food stimuli
|
Change from baseline at 6 months,12 months, and 18 months
|
Child Inhibition as measured by the Go No Go (GNG) Task
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
The Go No Go (GNG) task with food stimuli
|
Change from baseline at 6 months,12 months, and 18 months
|
Child Energy Intake
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
Automated Self-Administered 24-hour recall (ASA-24)
|
Change from baseline at 6 months,12 months, and 18 months
|
Parent Body Mass Index (BMI)
Time Frame: Change from baseline at 3 months, 6 months,12 months, and 18 months
|
kg/m^2
|
Change from baseline at 3 months, 6 months,12 months, and 18 months
|
Parent Overeating Episodes
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
The Eating Disorder Examination (EDE)
|
Change from baseline at 6 months,12 months, and 18 months
|
Parent Food Cue Responsiveness as measured by the Adult Eating Behavior Questionnaire
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
Measured by the Food Responsiveness (FR) Scale of the Adult Eating Behavior Questionnaire (AEBQ); scores range from 1-5 with higher scores equating to higher FR.
|
Change from baseline at 6 months,12 months, and 18 months
|
Parent Food Cue Responsiveness as measured during exposure to a preferred food
Time Frame: Change from baseline at 6 months,12 months, and 18 months]
|
The parent will be asked to hold, smell, and taste the highly craved food and rate their current cravings over the course of 5 minutes.
|
Change from baseline at 6 months,12 months, and 18 months]
|
Parent Satiety Responsiveness as measured by the Adult Eating Behavior Questionnaire
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
The Satiety Responsiveness Scale of the AEBQ; scores range from 1-5 with higher scores equating to higher SR
|
Change from baseline at 6 months,12 months, and 18 months
|
Parent Satiety Responsiveness as measured by the Water Load Task
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
The Water Load Task
|
Change from baseline at 6 months,12 months, and 18 months
|
Parent Inhibition as measured by the Stop Signal Task
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
Stop Signal Task with food stimuli
|
Change from baseline at 6 months,12 months, and 18 months
|
Parent Inhibition as measured by the Go No Go (GNG) Task
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
The Go No Go (GNG) task with food stimuli.
|
Change from baseline at 6 months,12 months, and 18 months
|
Parent Energy Intake
Time Frame: Change from baseline at 6 months,12 months, and 18 months
|
Automated Self-Administered 24-hour recall (ASA-24)
|
Change from baseline at 6 months,12 months, and 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kerri Boutelle, Ph.D., UC San Diego
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 Major Dates
Study Start (Actual)
April 3, 2024
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Study Registration Dates
First Submitted
January 5, 2024
First Submitted That Met QC Criteria
January 5, 2024
First Posted (Actual)
January 16, 2024
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 4, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 806055
- 1R01DK135599 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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