NCT06267547

Healthy Activities Improve Lives (HAIL)

Healthy Activities Improve Lives Randomized Control Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

The investigators have developed an online platform to support the 8-week, F\&S! 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 F\&S! program, or the combined HAIL Online Platform + F\&S! program to examine the efficacy of the HAIL online platform + F\&S! 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 + F\&S! program. We will enroll four cohorts (i.e., 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 F\&S! 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 F\&S! program, and then continue to use the HAIL online platform during the 3-mo follow-up.

Conditions

• Physical Activity

Interventions

Type	Name	Description
OTHER	HAIL Online Platform	The HAIL online platform was developed based on feedback from our focus groups with older adults affiliated with BMA churches (conducted per IRB Protocol 2020P003100). Specifically, the HAIL online platform has a landing page where participants can access the links to the F\&S! exercise sessions, complete the exercise log, obtain tips from an exercise instructor, as well as view study announcements. The landing page has a navigation bar on the left to access 1) the study assessments; 2) the F\&S! exercise program participant manual; and 3) information on how to contact study staff. The goal of this adjunctive HAIL online platform is to support the continuation of exercise in the follow-up period once the 8-week F\&S! exercise program is over. We conducted an open trial (per IRB protocol 2022P001782) to assess the feasibility and acceptability of the HAIL online platform adjunct to the F\&S! program, which yielded positive results.
BEHAVIORAL	Fit and Strong! Program	The Fit and Strong! Program (F\&S!) is an exercise program for older adults developed by a study consultant, Dr. Susan Hughes, with funding from the National Institute of Aging. It is tailored for the unique needs of older, underserved adults and targets modifiable factors depicted by the socioecological model is necessary. The F\&S! exercise program assists older adults to improve strength and functioning.

Timeline

• Start date: 2024-04-23
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2024-02-20
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States