Community Walks: Clinical Trial

Physical Inactivity Clinical Trial

Official title:

Multilevel Physical Activity Intervention for Low Income Public Housing Residents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05147298
• Other study ID #: H-42219
• Secondary ID: 1R01MD015165-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 543
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Other:
• eHealth phone program
The automated eHealth phone program uses text to speech technology to deliver educational content to increase awareness, confidence, and motivation for physical activity.
• Environment 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.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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