Obesity, ChildhoodFRESH-FRNCT06207110
Family, Responsibility, Education, Support, and Health for Food Responsiveness
A study testing Regulation of Cues, Family Based Behavioral Treatment and Regulation of Cues + in people with Obesity, Childhood, run by University of California, San Diego at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Regulation of Cues, Family Based Behavioral Treatment and Regulation of Cues +
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Apr 2024to 1 Jan 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 3.8 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 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
Who cannot join
- 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)
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, 92037
Kaylen Moline, MPH, 1-855-827-3498, chear@health.ucsd.edu
- Recruiting
Ambulatory Research Center - University of Minnesota
Minneapolis, Minnesota, 55454
Carol Peterson, Ph.D., 612-273-9811, peter161@umn.edu
About this study
Official title: 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).
Read the 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).
- Conditions
- Obesity, Childhood
- Being tested
- Regulation of Cues, Family Based Behavioral Treatment, Regulation of Cues +, Health Education
- Keywords
- Food Responsiveness, Satiety Responsiveness, Weight Loss, Overeating
- Medical subject headings
- Pediatric Obesity, Weight Loss, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulation of CuesBehavioural
Also called ROC
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 TreatmentBehavioural
Also called FBT
FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
Regulation of Cues +Behavioural
Also called ROC+
ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake
Health EducationBehavioural
Also called HE
The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
| Study group | Role | What they receive |
|---|---|---|
| Regulation of Cues | Experimental | The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning targeting increasing satiety responsiveness and decreasing food cue responsiveness. Receives: Behavioral: Regulation of Cues |
| Family-Based Treatment | Active comparator | The FBT program provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance. Receives: Behavioral: Family Based Behavioral Treatment |
| Regulation of Cues + | Experimental | The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake Receives: Behavioral: Regulation of Cues + |
| Health Education | Active comparator | The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child age and sex adjusted body mass index z-score (BMIz)
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
Measured: Change from baseline at 3 months, 6 months, 12 months, and 18 months
Child percentage of the 95th percentile BMI (%BMIp95)
Age and Sex specific percentage of the 95th percentile BMI
Measured: Change from baseline 3 months, 6 months, 12 months, and 18 months
Change in Child Overeating
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.
Measured: Change from baseline at 6 months,12 months, and 18 months
Secondary outcomes (16)
Child Food Cue Responsiveness as measured by the Child Eating Behavior Questionnaire
The Food Responsiveness (FR) Scale of the Child Eating Behavior Questionnaire; scores range from 1-5 with higher scores representing greater FR.
Measured: Change from baseline at 6 months,12 months, and 18 months]
Child Food Cue Responsiveness as measured during exposure to a preferred food
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.
Measured: Change from baseline at 6 months,12 months, and 18 months
Child Satiety Responsiveness as measured by the Child Eating Behavior Questionnaire
The Satiety Responsiveness (SR) scale of the Child Eating Behavior Questionnaire (CEBQ). Scores range from 1-5 with higher scores representing greater SR.
Measured: Change from baseline at 6 months,12 months, and 18 months
Child Satiety Responsiveness as measured by the Water Load Task (WLT)
The Water Load Task
Measured: Change from baseline at 6 months,12 months, and 18 months
Child Inhibition as measured by the Stop Signal Task
Stop Signal Task with food stimuli
Measured: Change from baseline at 6 months,12 months, and 18 months
Child Inhibition as measured by the Go No Go (GNG) Task
The Go No Go (GNG) task with food stimuli
Measured: Change from baseline at 6 months,12 months, and 18 months
Child Energy Intake
Automated Self-Administered 24-hour recall (ASA-24)
Measured: Change from baseline at 6 months,12 months, and 18 months
Parent Body Mass Index (BMI)
kg/m^2
Measured: Change from baseline at 3 months, 6 months,12 months, and 18 months
Parent Overeating
Eating in the Absence of Hunger Questionnaire; Scores ranging from 1-5 with greater scores meaning more eating in the absence of hunger.
Measured: Change from baseline at 6 months,12 months, and 18 months
Parent Food Cue Responsiveness as measured by the Adult Eating Behavior Questionnaire
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.
Measured: Change from baseline at 6 months,12 months, and 18 months
Parent Food Cue Responsiveness as measured during exposure to a preferred food
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.
Measured: Change from baseline at 6 months,12 months, and 18 months]
Parent Satiety Responsiveness as measured by the Adult Eating Behavior Questionnaire
The Satiety Responsiveness Scale of the AEBQ; scores range from 1-5 with higher scores equating to higher SR
Measured: Change from baseline at 6 months,12 months, and 18 months
Parent Satiety Responsiveness as measured by the Water Load Task
The Water Load Task
Measured: Change from baseline at 6 months,12 months, and 18 months
Parent Inhibition as measured by the Stop Signal Task
Stop Signal Task with food stimuli
Measured: Change from baseline at 6 months,12 months, and 18 months
Parent Inhibition as measured by the Go No Go (GNG) Task
The Go No Go (GNG) task with food stimuli.
Measured: Change from baseline at 6 months,12 months, and 18 months
Parent Energy Intake
Automated Self-Administered 24-hour recall (ASA-24)
Measured: Change from baseline at 6 months,12 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start3 Apr 2024
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Kerri Boutelle, University of California, San Diego
- Investigators
- Kerri Boutelle, Ph.D., Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207110
- Sponsor's protocol ID
- 806055
- Other IDs
- 1R01DK135599
- Acronym
- FRESH-FR
- Status last verified
- May 2025
- First submitted
- 5 Jan 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No