Healthy Activities Improve Lives (HAIL)
- Conditions
- Physical Activity
- Interventions
- Other: HAIL Online PlatformBehavioral: Fit and Strong! Program
- Registration Number
- NCT06267547
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HAIL Online Platform + Fit and Strong! Program HAIL Online Platform 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. HAIL Online Platform + Fit and Strong! Program Fit and Strong! Program 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. Fit and Strong! Program Fit and Strong! Program 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.
- Primary Outcome Measures
Name Time Method Acceptability (Feedback Form) Week 20 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.
Feasibility and Retention Week 20 Retention will be assessed by how many individuals completed the 3-month post-intervention follow-up
Acceptability (Exit Interviews) Week 20 Acceptability will finally be assessed with focus group exit interviews, which will be qualitatively coded.
Acceptability Week 8 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.
- Secondary Outcome Measures
Name Time Method Changes in Physical Strength Weeks 0, 8, 20 This outcome will be measured via the Timed-Stands Test.
Changes in Anxiety Weeks 0, 8, 20 Anxiety outcome will be measured via the Generalized Anxiety Disorder 7-item (GAD-7) scale. This is a 7-item anxiety scale with good reliability, as well as criterion, construct, factorial, and procedural validity. The raw score ranges from 0 to 21. Increasing scores are associated with multiple domains of functional impairment. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Changes in Physical Activity (MVPA) Weeks 0, 8, 20 Changes in physical activity will be measured by participants' daily number of minutes of moderate to vigorous physical activity (MVPA). This outcome will be measured via the GT3X ActiGraph accelerometer.
Chronic Conditions Week 0 Chronic conditions outcome will be measured via the Geri-AIMS. This is a19-item self-administered questionnaire adapted from the Arthritis Impact Measurement Scales (AIMS) for use with frail elderly respondents. The questionnaire assesses the presence of existing chronic medical conditions.
Changes in Physical Functioning Weeks 0, 8, 20 Physical function outcome will be measured via the Patient-Reported Outcomes Measurement Information-Physical Functiong. This is an 8-item scale assessing coordination, functional mobility, strength and upper extremity function. The raw score ranges from 0 to 40. Increasing scores are associated with higher physical functioning.
Utilization of Healthcare Resources Week 0 Utilization of healthcare resources outcome will be assessed via the Healthcare Utilization Form. This a descriptive measure used to assess utilization of healthcare resources in the past 6 months, and to better characterize the sample based on the number of comorbid conditions present. There is no scoring or total score.
Changes in Physical Activity (Steps) Weeks 0, 8, 20 Changes in physical activity will be measured by Participants' daily step counts. This outcome will be measured via the GT3X ActiGraph accelerometer.
Changes in Aerobic Capacity Weeks 0, 8, 20 This outcome will be measured via the 6 minute Walk Test.
Motivation to Change Week 0 Motivation to change outcome will be measured via the Readiness for Change Form. This is used to measure participants' motivation to participate in exercising. A high score indicates the respondent is more interested in participating in exercise activities. A low score indicates the respondent is less interested in participating in exercise activities.
Fall History Week 0 Fall history outcome will be measured via the Fall History Form. This form is used to assess the history of falling within the past two years in participants.
Changes in Depression Weeks 0, 8, 20 Depression outcome will be measured via the Patient Health Questionnaire (PHQ-9). This is a 9-item, standardized and validated questionnaire that assesses the prevalence and severity of depression based on the DSM-5 criteria. The raw score ranges from 0 to 27, 1 representing minimal depression and 27 representing severe depression.
Changes in Confidence in Exercises Weeks 0, 8, 20 Exercise confidence outcome will be measured via the Exercise Confidence Form. This is a 4-item questionnaire used to assess confidence in doing certain physical activities. The raw score ranges from 0 to 40. Increasing scores are associated with higher confidence in exercise.
Changes in Overall Wellbeing Weeks 0, 8, 20 Wellbeing will be measured via the WHO(Five) Well-Being Index (WHO-5). This is a reliable psychometric measure that predicts depression. The questionnaire consists of five items that assess predictors of depressive symptoms: positive mood, energy and interest. The raw score is calculated by totaling the figures of the five answers. The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.
Changes in Social Isolation Weeks 0, 8, 20 Social isolation outcome will be measured via the Patient-Reported Outcomes Measurement Information Short Form- Social Isolation 4. This is a 4-item scale used to capture participants' perception of being left out and disconnected from others. The raw score ranges from 0 to 20. Increasing scores are associated with higher feelings of social isolation.
Trial Locations
- Locations (1)
Roslindale Baptist Church
🇺🇸Boston, Massachusetts, United States