Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06267547
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-01-30
Brief Title:
Healthy Activities Improve Lives HAIL
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Healthy Activities Improve Lives Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
HAIL
Brief Summary:
The investigators have developed an online platform to support the 8-week FS exercise program called the Healthy Activity Improves Lives HAIL online platform The aim of this study is to perform a cluster randomization of four racially diverse churches or senior centers to either the standard FS program or the combined HAIL Online Platform FS program to examine the efficacy of the HAIL online platform FS program for older adults in black communities
Detailed Description:
This is randomized clinical trial of cluster randomization evaluating the efficacy and feasibility of the HAIL online platform FS program We will enroll four cohorts ie at two racially diverse churches or senior centers for a total number of 120 participants We will use a phone screen to assess participants eligibility and explain the study procedures Eligible individuals will then be given a link to complete an e-Consent in REDCap Those randomized into the intervention group will also receive instructions on how to access the HAIL online platform to complete assessments as part of the baseline visit Participants in both the intervention and comparison groups will complete the 8-week FS exercise program which will be delivered in-person as well as remote Participants in the intervention group will have access to the adjunct HAIL online platform during the FS program and then continue to use the HAIL online platform during the 3-mo follow-up
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