RYSE Family-based Behavioral Treatment for Childhood Obesity

NCT05212155 | Active Not Recruiting

• 1 other identifier: WU IRB 202103221
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

RYSE is a Family-based Approach for Healthy Lifestyles that is a program for families with children between the ages of 5-12 years old to help them make healthy lifestyle changes to reach a healthier weight. The research program does this with children and their families through guidance about healthy eating, physical activity, and behavior change. The program focuses on helping participating families set up healthy support systems at home, at school and in social settings.

Conditions

Obesity, Childhood

Keywords

behavioral treatment; lifestyle changes; exercise; Traffic Light Diet

Outcome Measures

Primary Outcomes (1)

• Child weight change outcome

  reduction, from baseline visit (BV), in child's percent overweight defined as (child's BMI - the median BMI \[for the child's sex and age\])/(median BMI) ×100

  25 weeks

Secondary Outcomes (1)

• Parent weight change outcome

  25 weeks

Study Arms (1)

Participating families

OTHER

Parent/child dyads enrolled in the open-label program

Behavioral: family-based behavioral treatment (FBT)

Interventions

family-based behavioral treatment (FBT) BEHAVIORAL

Individual and group treatment of parent/child dyads to improve dietary choices, minimize sedentary behaviors, increase physical activity levels, and identify social support environments that reinforce healthy lifestyle choices.

Participating families

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parents ≥ 18 years old
• Children age 5-12 y, with BMI percentile ≥95th for age and sex
• Child must be enrolled in Missouri Medicaid
• Parent and child are comfortable speaking English
• Child is receiving primary care at one of the participating clinics
• Child lives with the participating parent ≥50% time
• Child able to provide written or verbal (based on age) informed assent,
• Child and parent able to participate in scheduled sessions

You may not qualify if:

• Parent/Caregiver is not the legal guardian of the child
• Purging (self-induced vomiting, diuretic use, laxative use) as an eating disorder
• Family lives ≥ 1 hour from the study sites
• Families planning to move out of the study area during the 12-month study period
• Child is a ward of the state

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Centers for Disease Control and Prevention: collaborator
• Children's Mercy Hospital Kansas City: collaborator
• Freeman Health System: collaborator

Study Sites (2)

Freeman Health Pediatrics Clinics

Joplin, Missouri, 64804, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Denise E Wilfley, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The program is open-label.

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: January 27, 2022
• Study Start: January 31, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: 30 months after the database is closed.
• Access Criteria: Coded dataset with IRB approval, limited dataset with HIPAA agreement, and de-identified dataset are accessible.

Locations

US (2)