Actively Recruiting

Phase Not Applicable
Age: 7Years - 12Years
All Genders
Healthy Volunteers
NCT06207110

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

Led by University of California, San Diego · Updated on 2025-05-11

280

Participants Needed

2

Research Sites

247 weeks

Total Duration

On this page

Sponsors

U

University of California, San Diego

Lead Sponsor

U

University of Minnesota

Collaborating Sponsor

AI-Summary

What this Trial 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 7Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child aged 7 to 12 years with overweight or obesity (≥ 85th BMI percentile)
  • Child scores 3.8 or higher on the Food Responsiveness Scale indicating high food responsiveness
  • Parent responsible for food preparation willing to participate and can read, speak, and understand English at a minimum 5th grade level
  • Informed assent from the child and parental consent
  • Family willing to attend all assessment and treatment sessions and agree to randomization
  • Child on stable medication regimen affecting weight for at least 3 months
  • Child without medical conditions limiting ability to participate in physical activity and parent able to support physical activity
Not Eligible

You will not qualify if you...

  • Child with acute psychiatric disorders (e.g., acute suicidality, recent hospitalization, psychosis, bulimia nervosa)
  • Child with serious chronic physical diseases requiring physician supervision of diet and exercise (e.g., cystic fibrosis, type 1 diabetes)
  • Child currently taking medication for weight loss
  • Parent with acute psychiatric disorders (e.g., acute suicidality, recent hospitalization, psychosis, bipolar disorder, borderline personality disorder, moderate or severe alcohol or substance use disorder)
  • First degree relative or household member with anorexia or bulimia nervosa
  • Any medical or psychological condition that would make study participation difficult or unsafe

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

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

La Jolla, California, United States, 92037

Actively Recruiting

2

Ambulatory Research Center - University of Minnesota

Minneapolis, Minnesota, United States, 55454

Actively Recruiting

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Research Team

K

Kaylen Moline, MPH

CONTACT

K

Kerri Boutelle, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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