Obesity, ChildhoodRYSENCT05212155
RYSE Family-based Behavioral Treatment for Childhood Obesity
A study testing family-based behavioral treatment (FBT) in people with Obesity, Childhood, run by Washington University School of Medicine at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- family-based behavioral treatment (FBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Freeman Health Pediatrics Clinics
Joplin, Missouri, 64804
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Childhood
- Being tested
- family-based behavioral treatment (FBT)
- Keywords
- behavioral treatment, lifestyle changes, exercise, Traffic Light Diet
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family-based behavioral treatment (FBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participating families | Other | Parent/child dyads enrolled in the open-label program Receives: Behavioral: family-based behavioral treatment (FBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 25 weeks
Secondary outcomes (1)
Parent weight change outcome
percent change in weight from baseline
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start31 Jan 2022
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The program is open-label.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Children's Mercy Hospital Kansas City, Freeman Health System
- Responsible party
- Sponsor
- Investigators
- Denise E Wilfley, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212155
- Sponsor's protocol ID
- WU IRB 202103221
- Acronym
- RYSE
- Status last verified
- Jul 2024
- First submitted
- 25 Jan 2022
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-based Approach for Healthy Lifestyles (RYSE)
- ClinicalTrials.gov ID
- NCT05212155
- Acronym / sponsor ID
- RYSE / WU IRB 202103221
- Conditions
- Obesity, Childhood
- Keywords
- behavioral treatment, lifestyle changes, exercise, Traffic Light Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Children's Mercy Hospital Kansas City, Freeman Health System
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The program is open-label.
| Arm | Type | Receives |
|---|---|---|
| Participating families | Other | Behavioral: family-based behavioral treatment (FBT)Parent/child dyads enrolled in the open-label program |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Participating families |
Primary outcome
Child weight change outcome
Time frame: 25 weeks
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
1 secondary outcome
Parent weight change outcome
Time frame: 25 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise E Wilfley, PhD principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing family-based behavioral treatment (FBT) in people with Obesity, Childhood, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child weight change outcome (time frame: 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.