Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654323
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
The Dose Trial Dose Intensity of Behavioral Interventions for Childhood Obesity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Dose Trial Dose Intensity of Behavioral Interventions for Childhood Obesity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The research team is recruiting 900 children between the ages 5-17 with obesity from Tennessee and Louisiana The team is assigning children and their caregivers by chance to one of five groups In the first group 300 children and their caregivers receive 26 hours of IBT In the second group 300 children and their caregivers receive 13 hours of IBT The remaining three groups of 100 children and their caregivers receive 16 19 or 22 hours of IBT
Childrens healthcare providers nutritionists and social workers are providing IBT to each of the groups over six months At the start of the study and again after one year the research team is measuring the childrens body mass index or BMI BMI is a measure of a persons body fat based on their height and weight The team is also looking at the childrens
Diet
Exercise
Sleep
Media use
Quality of life
Childrens healthcare providers nutritionists and social workers are providing IBT to each of the groups over six months At the start of the study and again after one year the research team is measuring the childrens body mass index or BMI BMI is a measure of a persons body fat based on their height and weight The team is also looking at the childrens
Diet
Exercise
Sleep
Media use
Quality of life
Detailed Description:
The Dose study aims to evaluate the optimal number of contact hours ie dose of intensive behavioral lifestyle interventions for childhood obesity Current recommendations by the American Academy of Pediatrics AAP and the United States Preventive Services Task Force USPSTF suggest that intensive behavioral lifestyle interventions should have at least 26 hours of contact time This is a difficult standard to achieve as it requires significant resources from healthcare systems and time from families This study39s purpose is to test whether 26 hours is needed to achieve clinically meaningful reductions in child weight among children with obesity
The investigators will conduct a randomized clinical trial RCT where children are randomized to one of five treatment intensities 26 hours 22 hours 19 hours 16 hours or 13 hours The study will use a non-inferiority design can equal effectiveness be achieved comparing the 26-hour standard to reduced intensities
900 children with obesity ages 5-17 years old will be randomized with a focus on rural and minority communities in Tennessee TN and Louisiana LA The study will engage approximately 15 clinics in TN and 15 in LA
The intervention will be integrated into local pediatric primary care practices Participants in all arms will receive the same number of visits with their childs primary care provider 4 visits 1 hour total on-demand web-based learning modules that focus on building skills and knowledge in health behaviors 7 hours and community resource counseling sessions delivered by a social worker or similar healthcare professional 4 sessions 2 hours total The difference between arms will be in the frequency and duration of personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional 16 sessions 60 minutes per session 12 sessions 60 minutes per session 9 sessions 60 minutes per session 8 sessions 45 minutes per session or 6 sessions 30 minutes per session
The primary outcome is child body mass index BMI expressed as a percentage of the 95th percentile BMIp95 of the CDC growth curves over 12 months measured approximately 5 times Our primary hypothesis is that 13-hours will be non-inferior to 26-hours The analysis also includes multiple pre-specified sub-group analyses as there may be important subgroups who require more than 13 hours eg children with a very high starting BMI Secondary outcomes include changes in child quality of life and health behaviors The analysis will assess reach feasibility and accessibility of this approach for both participants and pediatric healthcare providers guided by the RE-AIM framework
The investigators will conduct a randomized clinical trial RCT where children are randomized to one of five treatment intensities 26 hours 22 hours 19 hours 16 hours or 13 hours The study will use a non-inferiority design can equal effectiveness be achieved comparing the 26-hour standard to reduced intensities
900 children with obesity ages 5-17 years old will be randomized with a focus on rural and minority communities in Tennessee TN and Louisiana LA The study will engage approximately 15 clinics in TN and 15 in LA
The intervention will be integrated into local pediatric primary care practices Participants in all arms will receive the same number of visits with their childs primary care provider 4 visits 1 hour total on-demand web-based learning modules that focus on building skills and knowledge in health behaviors 7 hours and community resource counseling sessions delivered by a social worker or similar healthcare professional 4 sessions 2 hours total The difference between arms will be in the frequency and duration of personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional 16 sessions 60 minutes per session 12 sessions 60 minutes per session 9 sessions 60 minutes per session 8 sessions 45 minutes per session or 6 sessions 30 minutes per session
The primary outcome is child body mass index BMI expressed as a percentage of the 95th percentile BMIp95 of the CDC growth curves over 12 months measured approximately 5 times Our primary hypothesis is that 13-hours will be non-inferior to 26-hours The analysis also includes multiple pre-specified sub-group analyses as there may be important subgroups who require more than 13 hours eg children with a very high starting BMI Secondary outcomes include changes in child quality of life and health behaviors The analysis will assess reach feasibility and accessibility of this approach for both participants and pediatric healthcare providers guided by the RE-AIM framework
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None