Healthy Activities Improve Lives Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Acceptability (Feedback Form)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Acceptability (Feedback Form)
时间窗: 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
时间窗: Week 20
Retention will be assessed by how many individuals completed the 3-month post-intervention follow-up
Acceptability (Exit Interviews)
时间窗: Week 20
Acceptability will finally be assessed with focus group exit interviews, which will be qualitatively coded.
Acceptability
时间窗: 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.
次要结局
- Changes in Anxiety(Weeks 0, 8, 20)
- Changes in Physical Activity (MVPA)(Weeks 0, 8, 20)
- Changes in Physical Strength(Weeks 0, 8, 20)
- Chronic Conditions(Week 0)
- Changes in Physical Functioning(Weeks 0, 8, 20)
- Utilization of Healthcare Resources(Week 0)
- Changes in Physical Activity (Steps)(Weeks 0, 8, 20)
- Changes in Aerobic Capacity(Weeks 0, 8, 20)
- Motivation to Change(Week 0)
- Fall History(Week 0)
- Changes in Depression(Weeks 0, 8, 20)
- Changes in Confidence in Exercises(Weeks 0, 8, 20)
- Changes in Overall Wellbeing(Weeks 0, 8, 20)
- Changes in Social Isolation(Weeks 0, 8, 20)
研究者
Louisa Grandin Sylvia
Associate Director and Associate Professor
Massachusetts General Hospital