Clinical trial NCT05212155: RYSE Family-based Behavioral Treatment for Childhood Obesity
Official title: Family-based Approach for Healthy Lifestyles (RYSE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Keywords: behavioral treatment
lifestyle changes
exercise
Traffic Light Diet
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Children's Mercy Hospital Kansas City
name: Freeman Health System
First posted: 2022-01-27
Enrollment: 108
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The program is open-label.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child weight change outcome
timeFrame: 25 weeks
Secondary outcomes:
measure: Parent weight change outcome
timeFrame: 25 weeks
Other outcomes:
Locations:
city: Joplin
country: United States
facility: Freeman Health Pediatrics Clinics
state: Missouri
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Denise E Wilfley, PhD
role: PRINCIPAL_INVESTIGATOR
References: