Healthy Activities Improve Lives (HAIL)

NCT06267547 | Active Not Recruiting

• 1 other identifier: 2023P003522
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (4)

• Feasibility and Retention

  Retention will be assessed by how many individuals completed the 3-month post-intervention follow-up

  Week 20

• Acceptability

  Acceptability will be assessed by the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 assesses acceptability and feasibility of the HAIL online platform and has demonstrated good reliability and validity. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

  Week 8

• Acceptability (Feedback Form)

  Acceptability will be assessed by the HAIL online Feedback form. We will develop a form to ask for tailored feedback on the F\&S! program and the HAIL online platform to better understand participants' satisfaction with specific aspects of this online program.

  Week 20

• Acceptability (Exit Interviews)

  Acceptability will finally be assessed with focus group exit interviews, which will be qualitatively coded.

  Week 20

Secondary Outcomes (14)

• Changes in Physical Activity (Steps)

  Weeks 0, 8, 20

• Changes in Physical Activity (MVPA)

  Weeks 0, 8, 20

• Changes in Aerobic Capacity

  Weeks 0, 8, 20

• Changes in Physical Strength

  Weeks 0, 8, 20

• Motivation to Change

  Week 0

Other Outcomes (4)

• Satisfaction with program

  Week 8

• Satisfaction with program

  Week 20

• Use of online program

  Week 8

Study Arms (2)

HAIL Online Platform + Fit and Strong! Program

EXPERIMENTAL

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.

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

Fit and Strong! Program

ACTIVE COMPARATOR

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.

Behavioral: Fit and Strong! Program

Interventions

HAIL Online Platform OTHER

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.

HAIL Online Platform + Fit and Strong! Program

Fit and Strong! Program BEHAVIORAL

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.

Fit and Strong! Program; HAIL Online Platform + Fit and Strong! Program

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Roslindale Baptist Church

Boston, Massachusetts, 02131, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director and Associate Professor

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 20, 2024
• Study Start: April 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (1)