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Completed

NCT Number: NCT05147298

Community Walks: Clinical Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eHealth phone program

Other

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

Other

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.

Primary outcomes

  1. 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).

  2. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Multilevel Physical Activity Intervention for Low Income Public Housing Residents

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 7, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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