Clinical trial NCT06267547: Healthy Activities Improve Lives (HAIL)
Official title: Healthy Activities Improve Lives Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Activity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-02-20
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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! 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

Primary outcomes:
measure: Feasibility and Retention
timeFrame: Week 20
measure: Acceptability
timeFrame: Week 8
measure: Acceptability (Feedback Form)
timeFrame: Week 20
measure: Acceptability (Exit Interviews)
timeFrame: Week 20
Secondary outcomes:
measure: Changes in Physical Activity (Steps)
timeFrame: Weeks 0, 8, 20
measure: Changes in Physical Activity (MVPA)
timeFrame: Weeks 0, 8, 20
measure: Changes in Aerobic Capacity
timeFrame: Weeks 0, 8, 20
measure: Changes in Physical Strength
timeFrame: Weeks 0, 8, 20
measure: Motivation to Change
timeFrame: Week 0
measure: Utilization of Healthcare Resources
timeFrame: Week 0
measure: Fall History
timeFrame: Week 0
measure: Chronic Conditions
timeFrame: Week 0
measure: Changes in Overall Wellbeing
timeFrame: Weeks 0, 8, 20
measure: Changes in Depression
timeFrame: Weeks 0, 8, 20
measure: Changes in Anxiety
timeFrame: Weeks 0, 8, 20
measure: Changes in Physical Functioning
timeFrame: Weeks 0, 8, 20
measure: Changes in Social Isolation
timeFrame: Weeks 0, 8, 20
measure: Changes in Confidence in Exercises
timeFrame: Weeks 0, 8, 20
Other outcomes:
measure: Satisfaction with program
timeFrame: Week 8
measure: Satisfaction with program
timeFrame: Week 20
measure: Use of online program
timeFrame: Week 8
measure: Use of online program
timeFrame: Week 20
Locations:
city: Boston
country: United States
facility: Roslindale Baptist Church
state: Massachusetts
Study officials:
References: