Healthy Activities Improve Lives (HAIL)

Mass General Brigham

Status: Active, not recruiting

Conditions: Physical Activity

Treatments: Other: HAIL Online Platform; Behavioral: Fit and Strong! Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06267547

2023P003522

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 55 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals over the age of 55 years
• Participants are able to travel to one of the churches for the in-person F&S! exercise sessions
• Participants cannot be currently participating in a regular PA program (i.e., at least 100 min per week of moderate to vigorous physical activities)

Exclusion criteria

• Participants do not understand study procedures or are unable to participate in the verbal consent process
• Participants must have a physician responsible for their medical care
• Participants endorse an item on the Revised Physical Activity Readiness Questionnaire (rPAR-Q) as confirmed by their treating physician
• Participants who report any contraindication to exercising (e.g., recent ECG changes or myocardial infarction, unstable angina, uncontrolled arrhythmias, third degree heart block, congestive heart failure)
• Participants who receive a score of 28 or higher on the Telephone Interview for Cognitive Status (TICS) during pre-screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

HAIL Online Platform + Fit and Strong! Program

Experimental group

Description:

Participants (N=60) will be recruited from two racially diverse churches or senior centers (30 participants per church/center) to examine the efficacy of the HAIL Online platform + F\&S! program for older adults in black communities. Participants will complete the 8-week F\&S! exercise program (with access to the adjunct HAIL online platform), which will be delivered in-person as well as remote, and then continue to use the HAIL online platform during the 3-mo follow-up.

Treatment:

Behavioral: Fit and Strong! Program

Other: HAIL Online Platform

Fit and Strong! Program

Active Comparator group

Description:

Participants (N=60) will be recruited from two racially diverse churches or senior centers (30 participants per church/center) to examine the feasibility and acceptability of the HAIL Online platform. Participants will complete the 8-week F\&S! exercise program (without access to the adjunct HAIL online platform), which will be delivered in-person as well as remote, and then complete the 3-mo follow-up.

Treatment:

Behavioral: Fit and Strong! Program