Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06207110

Conditions

Obesity, Childhood

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Accepted

Interventions

Regulation of Cues

Family Based Behavioral Treatment

Regulation of Cues +

Health Education

Study Details

Brief 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).

Conditions

Obesity, Childhood

Study ID

NCT06207110

Start date

Apr 3, 2024

Status verified date

May, 2025

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Accepted

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 Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

experimental: Regulation of Cues +

The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake

active comparator: Health Education

The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Interventions

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.

Primary outcome measure

  • 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 ]
  • Child percentage of the 95th percentile BMI (%BMIp95) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Locations

UC San Diego Center for Healthy Eating and Activity Research (CHEAR)

Recruiting

La Jolla, California, United States, 92037

Contacts

Ambulatory Research Center - University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Carol Peterson, Ph.D.

612-273-9811peter161@umn.edu

More Information

Sponsor

University of California, San Diego

Last update posted

May 11, 2025

Last verified

May, 2025

Keywords

  • Food Responsiveness
  • Satiety Responsiveness
  • Weight Loss
  • Overeating

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-05-11.