Community Walks: Clinical Trial
- Conditions
- Physical Inactivity
- Interventions
- Other: eHealth phone programOther: Environment program
- Registration Number
- NCT05147298
- Lead Sponsor
- Tufts Medical Center
- Brief Summary
This research study will investigate the independent effects of an environmental intervention (E only), an individual-level eHealth phone program intervention (I only), or both (E+I) on changes in moderate intensity physical activity. A cluster randomized design will be implemented whereby all residents of one of 12 of Boston's public housing developments (PHDs) will be randomized to one of the four study groups (E only, I only, E+I, or control). The activities with this multilevel design include:
* Screening/enrollment/baseline assessment activities
* Environmental components to promote moderate intensity walking and other physical activity at the PHDs
* Changing the environment surrounding the development making it more amenable to walking through the creation of walking trails and walking maps; and advocating for changes to the built environment
* Healthy Living Advocates (HLA)-led walking groups within the community
* Individual level components to increase motivation and self-efficacy for physical activity
* eHealth program, an automated telephone-based physical activity program
* 12-month and 24-month follow up assessment activities
The investigators hypothesize that the participants living in the PHDs in any of the three intervention groups (E only, I only, and E+I combined) will increase minutes of moderate intensity physical activity more than participants in control group developments at 24-month follow up. It is further expected that delivery of an intervention package targeting environmental and social cues to become active, combined with an individual level intervention, will improve overall physical activity levels to recommended guidelines at the development level. The findings will inform future health promotion efforts among residents in public housing developments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 543
- Willing to wear device to track physical activity during assessment periods
- Able to speak English or Spanish
- Current resident of Boston Public Housing Development or housing property on Boston Housing Authority owned land
- No plans to move within the next 2 years
- Has access to a phone (of any kind)
- Currently enrolled in a research study about physical activity that is incompatible with study participation
- Unable to provide informed consent in judgement of research assistant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Combined group (E and I interventions) Environment program Changing the environment surrounding the PHDs making it more amenable to walking and advocating for changes to the built environment and an automated telephone-based physical activity program. Combined group (E and I interventions) eHealth phone program Changing the environment surrounding the PHDs making it more amenable to walking and advocating for changes to the built environment and an automated telephone-based physical activity program. Environmental group intervention (E only) Environment program Changing the environment surrounding the PHDs making it more amenable to walking and advocating for changes to the built environment Individual-level eHealth phone program intervention (I only) eHealth phone program An automated telephone-based physical activity program.
- Primary Outcome Measures
Name Time Method Change in minutes of light, moderate, and vigorous intensity physical activity per day at 12 months baseline, 12 months Assessed by (1) evaluating the proportion of accelerometers distributed and returned, (2) downloading the data from the devices, (3) processing the data (e.g., removing outliers), and (4) examining the proportion that have valid data (i.e., minimum 3 days of wear).
Change in minutes of light, moderate, and vigorous intensity physical activity per day at 24 months baseline, 24 months Assessed by (1) evaluating the proportion of accelerometers distributed and returned, (2) downloading the data from the devices, (3) processing the data (e.g., removing outliers), and (4) examining the proportion that have valid data (i.e., minimum 3 days of wear).
- Secondary Outcome Measures
Name Time Method Evaluate the mediator effects of motivation baseline, 12 months, 24 months This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire.
Evaluate the mediator effects fidelity to the interventions baseline, 12 months, 24 months This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire.
Evaluate the mediator effects of self-efficacy baseline, 12 months, 24 months This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire.
Evaluate the mediator effects of neighborhood walkability baseline, 12 months, 24 months This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire.
Evaluate the mediator effects of support from HLAs baseline, 12 months, 24 months This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire.
Trial Locations
- Locations (1)
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States