Healthy Activities Improve Lives

NCT05670223 | Completed

• 2 other identifiers: 2022P001782R21AG067091
• Study Type: interventional
• Target: 36
• 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 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).

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (4)

• Feasibility and Retention

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

  Week: 20

• Acceptability

  Acceptability will be assessed by:1) Client Satisfaction Questionnaire (CSQ-8), 2) F\&S! - online Feedback form, 3) Focus group exit interviews. The CSQ-8 assesses acceptability and feasibility of the F\&S!-Online program and has demonstrated good reliability and validity. We will develop a form to ask for tailored feedback on the F\&S-Online program to better understand participants' satisfaction with specific aspects of this online program. We will also conduct exit interviews with focus group and pilot study participants

  Week: 0

• Acceptability

  Acceptability will be assessed by:1) Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 assesses acceptability and feasibility of the F\&S!-Online program and has demonstrated good reliability and validity.

  Week: 8

• Acceptability

  Acceptability will be assessed by :1) Client Satisfaction Questionnaire (CSQ-8), 2) F\&S! - online Feedback form, 3) Focus group exit interviews. The CSQ-8 assesses acceptability and feasibility of the F\&S!-Online program and has demonstrated good reliability and validity. We will develop a form to ask for tailored feedback on the F\&S-Online program to better understand participants' satisfaction with specific aspects of this online program. We will also conduct exit interviews with focus group and pilot study participants

  Week: 20

Secondary Outcomes (12)

• Changes in Aerobic Capacity

  Weeks: 0 , 8 , 20

• Changes in Physical Strength

  Weeks: 0 , 8 , 20

• Motivation to Change

  Weeks: 0

• Utilization of Healthcare Resources

  Weeks: 0

• Fall History

  Weeks: 0

Other Outcomes (4)

• Satisfaction with program

  Week: 8

• Satisfaction with program

  Week: 20

• Use of online program

  Weeks: 8

Study Arms (1)

Open Pilot Group

EXPERIMENTAL

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.

Other: Fit&Strong Exercise Program

Interventions

Fit&Strong Exercise Program 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.

Open Pilot Group

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

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)

Sponsors & Collaborators

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

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Louisa Sylvia, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 4, 2023
• Study Start: September 30, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

US (1)