RECRUITING

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

Conditions

Obesity, Childhood Food Responsiveness Satiety Responsiveness Weight Loss Overeating

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-04-03

Study Completion:2029-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06207110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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 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	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.

Inclusion Criteria

Exclusion 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 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

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.

Contacts and Locations

Study Contact

Kaylen Moline, MPH

CONTACT

1-855-827-3498

chear@ucsd.edu

Kerri Boutelle, Ph.D.

CONTACT

858-249-3528

kboutelle@ucsd.edu

Principal Investigator

Kerri Boutelle, Ph.D.

PRINCIPAL_INVESTIGATOR

UC San Diego

Study Locations (Sites)

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

La Jolla, California, 92037

United States

Ambulatory Research Center - University of Minnesota

Minneapolis, Minnesota, 55454

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Kerri Boutelle, Ph.D., PRINCIPAL_INVESTIGATOR, UC San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-03

Study Completion Date2029-01-01

Study Record Updates

Study Start Date2024-04-03

Study Completion Date2029-01-01

Terms related to this study

Keywords Provided by Researchers

Food Responsiveness
Satiety Responsiveness
Weight Loss
Overeating

Additional Relevant MeSH Terms

Obesity, Childhood