Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432790
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-22
Brief Title:
Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program In-person vs ONline
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program In-person vs ONline CHAMPION
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHAMPION
Brief Summary:
The goal of this study is to evaluate the effectiveness of CHAMPION Comparative-effectiveness of a Healthy lifestyle and Asthma Management Program In-person vs ONline a primary care-based intervention to address childhood obesity and asthma and test the effectiveness of a telehealth-only version of the program Intensive Health Behavior and Lifestyle Treatment IHBLT when delivered via telehealth vs in-person among children with overweight or obesity and persistent asthma
Detailed Description:
This study will evaluate the comparative effectiveness of 1 telehealth delivery of CHAMPION vs 2 in-person standard of care delivery of CHAMPION in a two-arm individually randomized non-inferiority trial among 500 children Obesity and asthma are two leading chronic diseases in children and CHAMPION is an integration of the Healthy Weight Clinic HWC and pediatric Asthma Population Health Management Programming at Mass General Brigham This study will address how to improve access to effective treatments consistent with United States Preventive Services Task Force USPSTF and American Academy of Pediatrics AAP guidelines that manage asthma and obesity concurrently in primary care among lower income diverse populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TE-2022C3-30362 | OTHER_GRANT | Patient-Centered Outcomes Research Institute PCORI | None |