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

Purpose

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).

Condition

  • Obesity, Childhood

Eligibility

Eligible Ages
Between 7 Years and 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: 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.
    Other names:
    • ROC
  • Behavioral: Regulation of Cues +
    ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake
    Other names:
    • ROC+
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.
  • Behavioral: Family Based Behavioral Treatment
    FBT provides nutrition and physical activity education, behavior therapy skills, and parenting skills targeting changes in energy balance.
    Other names:
    • FBT
Experimental
Regulation of Cues + 		The ROC+ program includes all of the components of ROC as well as nutrition education and reducing energy intake
  • Behavioral: Regulation of Cues +
    ROC+ includes all of the skills provided in ROC but integrates nutrition education and reducing energy intake
    Other names:
    • ROC+
Active Comparator
Health Education 		The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
  • Behavioral: Health Education
    The HE program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
    Other names:
    • HE

Recruiting Locations

UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
La Jolla 5363943, California 5332921 92037
Contact:
Kaylen Moline, MPH
1-855-827-3498
chear@health.ucsd.edu

Ambulatory Research Center - University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55454
Contact:
Carol Peterson, Ph.D.
612-273-9811
peter161@umn.edu

More Details

Status
Recruiting
Sponsor
University of California, San Diego

Study Contact

Kaylen Moline, MPH
1-855-827-3498
chear@ucsd.edu

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).