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

University of California San Diego

Status: Enrolling

Conditions: Obesity, Childhood

Treatments: Behavioral: Health Education; Behavioral: Regulation of Cues +; Behavioral: Regulation of Cues; Behavioral: Family Based Behavioral Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06207110

806055

1R01DK135599 (U.S. NIH Grant/Contract)

Details and patient eligibility

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).

Full 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).

Enrollment: 280 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

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 4 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 and parent 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. Parent is pregnant or planning on becoming pregnant or lactating during the duration of the study
6. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 4 patient groups

Regulation of Cues

Experimental group

Description:

The ROC program provides psychoeducation, coping skills, self-monitoring and experiential learning targeting increasing satiety responsiveness and decreasing food cue responsiveness.

Treatment:

Behavioral: Regulation of Cues

Family-Based Treatment

Active Comparator group

Description:

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

Treatment:

Behavioral: Family Based Behavioral Treatment

Regulation of Cues +

Experimental group

Description:

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

Treatment:

Behavioral: Regulation of Cues +

Health Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Health Education