Clinical trial NCT05147298: Community Walks: Clinical Trial
Official title: Multilevel Physical Activity Intervention for Low Income Public Housing Residents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physical Inactivity
Keywords: Public housing developments (PHDs)
Environmental level interventions
Individual level interventions
eHealth phone program
Healthy living advocates
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2021-12-07
Enrollment: 543
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Change in minutes of light, moderate, and vigorous intensity physical activity per day at 12 months
timeFrame: baseline, 12 months
measure: Change in minutes of light, moderate, and vigorous intensity physical activity per day at 24 months
timeFrame: baseline, 24 months
Secondary outcomes:
measure: Evaluate the mediator effects of motivation
timeFrame: baseline, 12 months, 24 months
measure: Evaluate the mediator effects of self-efficacy
timeFrame: baseline, 12 months, 24 months
measure: Evaluate the mediator effects of neighborhood walkability
timeFrame: baseline, 12 months, 24 months
measure: Evaluate the mediator effects of support from HLAs
timeFrame: baseline, 12 months, 24 months
measure: Evaluate the mediator effects fidelity to the interventions
timeFrame: baseline, 12 months, 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Lisa M Quintiliani, PhD
role: PRINCIPAL_INVESTIGATOR
References: