Healthy Activities Improve Lives

NCT ID: NCT05670223

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-09-30

Brief Summary

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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 aims of this study are to conduct an open pilot trial with exit interviews (N=30) of the HAIL online platform in two racially diverse churches to evaluate its feasibility and acceptability (Hypothesis 1) as well as explore its efficacy (Hypothesis 2).

Detailed Description

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This is an open pilot study to evaluate the feasibility and accessibility of the HAIL online platform. This study will enroll two cohorts (i.e., at two racially diverse churches) for a total number of 30 participants. This study 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 as well as instructions on how to access the HAIL online platform to complete assessments as part of the baseline visit. 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.

Conditions

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Physical Activity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Open Pilot Group

Participants (N=30) will be recruited across two churches, MorningStar Baptist Church and People's Baptist Church, to examine the feasibility and acceptability of the HAIL Online platform. 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.

Group Type EXPERIMENTAL

Fit&Strong Exercise Program

Intervention Type OTHER

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.

Interventions

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Fit&Strong Exercise 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.

Intervention Type OTHER

Eligibility Criteria

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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 (physical activity) 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)
Minimum Eligible Age

60 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Louisa Grandin Sylvia

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louisa Sylvia, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R21AG067091

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022P001782

Identifier Type: -

Identifier Source: org_study_id

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