RYSE Family-based Behavioral Treatment for Childhood Obesity (RYSE)

Family-based Approach for Healthy Lifestyles (RYSE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: family-based behavioral treatment (FBT)

Detailed Description

Reducing the human and economic burden of obesity is a public health priority. Obesity disproportionately affects Black children (20% vs. 15% of White children)7 and low-income children. Family-based Behavioral Treatment (FBT) for childhood obesity is an effective, standardized behavioral intervention that has been developed and tested over the past 30 years by Drs. Leonard Epstein, Denise Wilfley, and colleagues. FBT targets both child and parent, with lasting positive effects that can extend to the family. FBT provides children and parents with new ways of thinking about their diet and exercise in order to support changes that support a healthy lifestyle. Participants work with "coaches" in individual sessions and in group sessions to both tailor the intervention to the family and provide an opportunity for social facilitation with other families that are participating. Missouri Medicaid (MOHealthNet) began reimbursement of 26 weeks of behavioral treatment for adult and child obesity on March 30, 2021. The FBT program implementation is designed to take advantage of this new benefit at clinical practices with the intent of creating a way to expand a workforce and standardize a program that can be disseminated across Missouri and possibly nationwide.

The purpose of the this research program is to evaluate for possible dissemination an online training program for FBT coaches, as well the implementation of the program, particularly in underserved rural and urban Black communities.

Participants comprise a dyad of parent and child. Full time caregivers that live with the dyad may participate in place of the parent, if the parent is unable to commit to the weekly sessions. Parental consent is required for the caregiver and the caregiver provides separate consent.

Participants attend weekly FBT group sessions with 3-10 participating families for 17 weeks, then 2 monthly individual sessions in month 5 and 6. This meets the 26-week Medicaid benefit requirement. Group sessions provide didactic content to support the families efforts to realign their diet and increase their exercise. Significant emphasis is placed on social networking, within the group session and in the participants' community, which is associated with better outcomes. There are 5 program sessions during the 6 months that are individual, with just the coach and the dyad. These are where program assessments are completed and the family and coach collaborate on goals and ways to meet them. The families also have two medical nutrition therapy consultations with registered dietitians. These are clinical interventions and not part of the research program structure. After the 26 weeks, the family returns for a 12-month research assessment, which is the final visit of the program.

When all participants have completed, matched-controls will be drawn from the electronic health record (EHR) at both clinical sites. Additional data are collected from the EHR to support cost analysis and implementation evaluation at the participant and organization levels.

This research program is being conducted at pediatric practices affiliated with Children's Mercy Hospital, Kansas City, MO and Freeman Health System, Joplin, MO. Washington University in St. Louis (WUSTL) is the primary award site and is responsible for FBT coach training and fidelity.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Joplin, Missouri, United States, 64804
      • Freeman Health Pediatrics Clinics
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Participating families; Parent/child dyads enrolled in the open-label program	Behavioral: family-based behavioral treatment (FBT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent weight change outcome	percent change in weight from baseline	25 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Centers for Disease Control and Prevention; Children's Mercy Hospital Kansas City; Freeman Health System
• Investigators: Principal Investigator: Denise E Wilfley, PhD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: exercise; behavioral treatment; lifestyle changes; Traffic Light Diet
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: WU IRB 202103221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All investigators on this project will be freely sharing data, with the PI collaborating with the co-investigators to coordinate the timing and topics of resulting publications.

Access is restricted to de-identified data within 30 months following the end of data collection. Data requests may be sent in writing to the Principal Investigator, Denise Wilfley. Before being given access to the data, Protected Health Information (PHI) is removed and secondary users are asked to sign a data use agreement that defines conditions for the use of the data. Secondary users are asked to provide a brief description of the analyses they wish to perform. The restricted access agreement stipulates that the user is obliged to ensure the security and confidentiality of the data, that the data are used for Institutional Review Board (IRB)-approved purposes only, and that no effort will be made to identify individual participants.

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No