Community Walks: Clinical Trial

Study Overview
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Brief Summary
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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.

Official Title
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Multilevel Physical Activity Intervention for Low Income Public Housing Residents

Conditions
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Physical Inactivity

Intervention / Treatment
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* Other: eHealth phone program
* Other: Environment program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Environmental group intervention (E only)<br>Changing the environment surrounding the PHDs making it more amenable to walking and advocating for changes to the built environment | Other: Environment program<br>* The environment surrounding the PHDs will be changed to make it more amenable to walking by creating walking trails and walking maps and using Healthy Living Advocates (HLA)-led walking groups within the community. Also advocating for changes to the built environment.<br>|
| Experimental: Individual-level eHealth phone program intervention (I only)<br>An automated telephone-based physical activity program. | Other: eHealth phone program<br>* The automated eHealth phone program uses text to speech technology to deliver educational content to increase awareness, confidence, and motivation for physical activity.<br>|
| Experimental: Combined group (E and I interventions)<br>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. | Other: eHealth phone program<br>* The automated eHealth phone program uses text to speech technology to deliver educational content to increase awareness, confidence, and motivation for physical activity.<br>Other: Environment program<br>* The environment surrounding the PHDs will be changed to make it more amenable to walking by creating walking trails and walking maps and using Healthy Living Advocates (HLA)-led walking groups within the community. Also advocating for changes to the built environment.<br>|
| No Intervention: Control group (no interventions)<br>No interventions for residents to increase activity levels. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in minutes of light, moderate, and vigorous intensity physical activity per day at 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., 7 days of wear - minimum 4 days). | baseline, 12 months | 
| Change in minutes of light, moderate, and vigorous intensity physical activity per day at 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., 7 days of wear - minimum 4 days). | baseline, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the mediator effects of motivation | This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire. | baseline, 12 months, 24 months | 
| Evaluate the mediator effects of self-efficacy | This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire. | baseline, 12 months, 24 months | 
| Evaluate the mediator effects of neighborhood walkability | This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire. | baseline, 12 months, 24 months | 
| Evaluate the mediator effects of support from HLAs | This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire. | baseline, 12 months, 24 months | 
| Evaluate the mediator effects fidelity to the interventions | This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire. | baseline, 12 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Public housing developments (PHDs), Environmental level interventions, Individual level interventions, eHealth phone program, Healthy living advocates