Skip to main content
Clinical Trials/NCT05147298
NCT05147298
Active, not recruiting
Not Applicable

Multilevel Physical Activity Intervention for Low Income Public Housing Residents

Tufts Medical Center1 site in 1 country543 target enrollmentMay 2, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Inactivity
Sponsor
Tufts Medical Center
Enrollment
543
Locations
1
Primary Endpoint
Change in minutes of light, moderate, and vigorous intensity physical activity per day at 12 months
Status
Active, not recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2022
End Date
January 1, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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).

Secondary Outcomes

  • Evaluate the mediator effects of motivation(baseline, 12 months, 24 months)
  • Evaluate the mediator effects fidelity to the interventions(baseline, 12 months, 24 months)
  • Evaluate the mediator effects of self-efficacy(baseline, 12 months, 24 months)
  • Evaluate the mediator effects of neighborhood walkability(baseline, 12 months, 24 months)
  • Evaluate the mediator effects of support from HLAs(baseline, 12 months, 24 months)

Study Sites (1)

Loading locations...

Similar Trials