Family, Responsibility, Education, Support, and Health for Food Responsiveness (FRESH-FR)

May 6, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kaylen Moline, MPH
  • Phone Number: 1-855-827-3498
  • Email: chear@ucsd.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • Ambulatory Research Center - University of Minnesota
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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 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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
Other Names:
  • ROC
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.
Behavioral: Family Based Behavioral Treatment
FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
Other Names:
  • FBT
Experimental: Regulation of Cues +
The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake
Behavioral: Regulation of Cues +
ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake
Other Names:
  • ROC+
Active Comparator: Health Education
The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
Behavioral: Health Education
The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
Other Names:
  • HE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change in Child Overeating
Time Frame: Change from baseline at 6 months,12 months, and 18 months
Measured by The Eating in the Absence of Hunger Questionnaire; Scores ranging from 1-5 with greater scores meaning more eating in the absence of hunger.
Change from baseline at 6 months,12 months, and 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 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
Parent Overeating
Time Frame: Change from baseline at 6 months,12 months, and 18 months
Eating in the Absence of Hunger Questionnaire; Scores ranging from 1-5 with greater scores meaning more eating in the absence of hunger.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kerri Boutelle, Ph.D., UC San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 806055
  • 1R01DK135599 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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