Healthy Activities Improve Lives (HAIL) (HAIL)

October 28, 2025 updated by: Louisa Grandin Sylvia, Massachusetts General Hospital

Healthy Activities Improve Lives Randomized Control Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Roslindale Baptist Church

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HAIL Online Platform + 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.
Other: HAIL Online Platform
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.
Behavioral: Fit and Strong! 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.
Active Comparator: 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.
Behavioral: Fit and Strong! 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility and Retention
Time Frame: Week 20
Retention will be assessed by how many individuals completed the 3-month post-intervention follow-up
Week 20
Acceptability
Time Frame: 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.
Week 8
Acceptability (Feedback Form)
Time Frame: 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.
Week 20
Acceptability (Exit Interviews)
Time Frame: Week 20
Acceptability will finally be assessed with focus group exit interviews, which will be qualitatively coded.
Week 20

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Physical Activity (Steps)
Time Frame: 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.
Weeks 0, 8, 20
Changes in Physical Activity (MVPA)
Time Frame: 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.
Weeks 0, 8, 20
Changes in Aerobic Capacity
Time Frame: Weeks 0, 8, 20
This outcome will be measured via the 6 minute Walk Test.
Weeks 0, 8, 20
Changes in Physical Strength
Time Frame: Weeks 0, 8, 20
This outcome will be measured via the Timed-Stands Test.
Weeks 0, 8, 20
Motivation to Change
Time Frame: 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.
Week 0
Utilization of Healthcare Resources
Time Frame: 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.
Week 0
Fall History
Time Frame: 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.
Week 0
Chronic Conditions
Time Frame: 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.
Week 0
Changes in Overall Wellbeing
Time Frame: 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.
Weeks 0, 8, 20
Changes in Depression
Time Frame: 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.
Weeks 0, 8, 20
Changes in Anxiety
Time Frame: 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.
Weeks 0, 8, 20
Changes in Physical Functioning
Time Frame: 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.
Weeks 0, 8, 20
Changes in Social Isolation
Time Frame: 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.
Weeks 0, 8, 20
Changes in Confidence in Exercises
Time Frame: 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.
Weeks 0, 8, 20

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction with program
Time Frame: Week 8
This outcome will be measured via the Client Satisfaction Questionnaire (CSQ-8). Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Week 8
Satisfaction with program
Time Frame: Week 20
This outcome will be measured via the Client Satisfaction Questionnaire (CSQ-8). Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Week 20
Use of online program
Time Frame: Week 8
This outcome will be assessed via the F&S! Program feedback from. This form consists of 8 questions and a semistructured exit interview of 4 questions. There is no scoring or total score.
Week 8
Use of online program
Time Frame: Week 20
This outcome will be assessed via the F&S! Program feedback from. This form consists of 8 questions and a semistructured exit interview of 4 questions. There is no scoring or total score.
Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023P003522

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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