RYSE Family-based Behavioral Treatment for Childhood Obesity

Obesity, Childhood Clinical Trial

— RYSE  

Official title:

Family-based Approach for Healthy Lifestyles (RYSE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05212155
• Other study ID #: WU IRB 202103221
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Freeman Health Pediatrics Clinics	Joplin	Missouri
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	Centers for Disease Control and Prevention, Children's Mercy Hospital Kansas City, Freeman Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Parent weight change outcome	percent change in weight from baseline	25 weeks