Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06207110

Recruiting nowNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age7 Years to 12 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Childhood

Full registry criteria

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.

Treatments and study arms

Regulation of Cues

Behavioral

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

Behavioral

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

Health Education

Behavioral

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

Primary outcomes

Child age and sex adjusted body mass index z-score (BMIz)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

Child percentage of the 95th percentile BMI (%BMIp95)Change from baseline 3 months, 6 months, 12 months, and 18 months

Age and Sex specific percentage of the 95th percentile BMI

Change in Child OvereatingChange 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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

UC San Diego Center for Healthy Eating and Activity Research (CHEAR)🇺🇸 La Jolla, California, United States
Kaylen Moline, MPHContact
Ambulatory Research Center - University of Minnesota🇺🇸 Minneapolis, Minnesota, United States
Carol Peterson, Ph.D.Contact