Family, Responsibility, Education, Support, and Health for Food Responsiveness

N/ARecruitingNCT06207110

University of California, San Diego280 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

280

Conditions

Obesity, Childhood

Interventions

Regulation of CuesBEHAVIORAL

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 TreatmentBEHAVIORAL

FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.

Regulation of Cues +BEHAVIORAL

ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake

Eligibility

Sex: ALLMin age: 7 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

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

La Jolla, California, United States

RECRUITING

Ambulatory Research Center - University of Minnesota

Minneapolis, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: Change from baseline at 6 months,12 months, and 18 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Central Contacts

Kaylen Moline, MPH

CONTACT

1-855-827-3498 chear@ucsd.edu

Kerri Boutelle, Ph.D.

CONTACT

858-249-3528 kboutelle@ucsd.edu

Data from ClinicalTrials.gov

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