- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05147298
Community Walks: Clinical Trial
Multilevel Physical Activity Intervention for Low Income Public Housing Residents
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Environmental group intervention (E only)
Changing the environment surrounding the PHDs making it more amenable to walking and advocating for changes to the built environment
|
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.
|
|
Experimental: Individual-level eHealth phone program intervention (I only)
An automated telephone-based physical activity program.
|
The automated eHealth phone program uses text to speech technology to deliver educational content to increase awareness, confidence, and motivation for physical activity.
|
|
Experimental: Combined group (E and I interventions)
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.
|
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.
The automated eHealth phone program uses text to speech technology to deliver educational content to increase awareness, confidence, and motivation for physical activity.
|
|
No Intervention: Control group (no interventions)
No interventions for residents to increase activity levels.
|
What is the study measuring?
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
Time Frame: 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).
|
baseline, 12 months
|
|
Change in minutes of light, moderate, and vigorous intensity physical activity per day at 24 months
Time Frame: 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).
|
baseline, 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the mediator effects of motivation
Time Frame: baseline, 12 months, 24 months
|
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
Time Frame: baseline, 12 months, 24 months
|
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
Time Frame: baseline, 12 months, 24 months
|
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
Time Frame: baseline, 12 months, 24 months
|
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
Time Frame: baseline, 12 months, 24 months
|
This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire.
|
baseline, 12 months, 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa M Quintiliani, PhD, Tufts Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-42219
- 1R01MD015165-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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