Healthy Activities Improve Lives (HAIL)

Last updated: April 26, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Treatment

Fit and Strong! Program

HAIL Online Platform

Clinical Study ID

NCT06267547
2023P003522
  • Ages 60-100
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals over the age of 60 years
  • Participants are able to travel to one of the churches for the in-person F&S! exercisesessions
  • 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

Exclusion Criteria:

  • Participants do not understand study procedures or are unable to participate in theverbal 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 changesor myocardial infarction, unstable angina, uncontrolled arrhythmias, third degreeheart block, congestive heart failure)
  • Participants who receive a score of 28 or higher on the Telephone Interview forCognitive Status (TICS) during pre-screening

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Fit and Strong! Program
Phase:
Study Start date:
April 23, 2024
Estimated Completion Date:
February 01, 2027

Study 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.

Connect with a study center

  • Roslindale Baptist Church

    Boston, Massachusetts 02131
    United States

    Active - Recruiting

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