Summary

Eligibility
for people ages 7-12 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Kerri Boutelle, Ph.D. (ucsd)

Description

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).

Official Title

Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat

Details

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).

Keywords

Obesity, Childhood, Food Responsiveness, Satiety Responsiveness, Weight Loss, Overeating, Pediatric Obesity, Regulation of Cues, Family Based Behavioral Treatment, Regulation of Cues +, Health Education

Eligibility

You can join if…

Open to people ages 7-12

  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

You CAN'T join if...

  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.

Locations

  • UC San Diego Center for Healthy Eating and Activity Research (CHEAR) accepting new patients
    La Jolla California 92037 United States
  • Ambulatory Research Center - University of Minnesota not yet accepting patients
    Minneapolis Minnesota 55454 United States

Lead Scientist at University of California Health

  • Kerri Boutelle, Ph.D. (ucsd)
    Professor, Pediatrics, Vc-health Sciences-schools. Authored (or co-authored) 142 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06207110
Study Type
Interventional
Participants
Expecting 280 study participants
Last Updated