RecruitingNot ApplicableNCT06207110

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

Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat


Sponsor

University of California, San Diego

Enrollment

280 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 7 YearsMax Age: 12 Years

Inclusion Criteria7

  • Informed assent and parental consent
  • A child with overweight or obesity (≥ 85th BMI%) aged 7-12 years of age
  • 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.
  • 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
  • Family is willing to commit to attending all assessment and treatment sessions, agree to be randomized and participate in all aspects of potential treatments
  • Child is on stable medication regimen for medications that can impact weight (3+ months)
  • 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 Criteria6

  • Acute child psychiatric disorder diagnoses (e.g., acute suicidality, recent hospitalization, psychosis, bulimia nervosa)
  • 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
  • Child who is taking medication for weight loss
  • Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar disorder, borderline personality disorder, moderate or severe alcohol or substance use disorder)
  • 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.

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Interventions

BEHAVIORALRegulation 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.

BEHAVIORALFamily Based Behavioral Treatment

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

BEHAVIORALRegulation of Cues +

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

BEHAVIORALHealth Education

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


Locations(2)

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

La Jolla, California, United States

Ambulatory Research Center - University of Minnesota

Minneapolis, Minnesota, United States

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NCT06207110


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