Community Walks: Clinical Trial

NCT05147298 | Completed

• 2 other identifiers: H-422191R01MD015165-01A1
• Study Type: interventional
• Target: 543
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity

Keywords

Public housing developments (PHDs); Environmental level interventions; Individual level interventions; eHealth phone program; Healthy living advocates

Outcome Measures

Primary Outcomes (2)

• 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., minimum 3 days of wear).

  baseline, 12 months

• 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., minimum 3 days of wear).

  baseline, 24 months

Secondary Outcomes (5)

• Evaluate the mediator effects of motivation

  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

• Evaluate the mediator effects fidelity to the interventions

  baseline, 12 months, 24 months

Study Arms (4)

Environmental group intervention (E only)

EXPERIMENTAL

Changing the environment surrounding the PHDs making it more amenable to walking and advocating for changes to the built environment

Other: Environment program

Individual-level eHealth phone program intervention (I only)

EXPERIMENTAL

An automated telephone-based physical activity program.

Other: eHealth phone program

Combined group (E and I interventions)

EXPERIMENTAL

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.

Other: eHealth phone program; Other: Environment program

Control group (no interventions)

NO INTERVENTION

No interventions for residents to increase activity levels.

Interventions

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.

Combined group (E and I interventions); Environmental group intervention (E only)

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.

Combined group (E and I interventions); Individual-level eHealth phone program intervention (I only)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Quintiliani LM, Dedier J, Amezquita M, Sierra-Ruiz M, Romero D, Murillo J, Mahar S, Goodman M, Kane JB, Cummings D, Woolley TG, Spinola I, Crouter SE. Community Walks: a cluster randomized controlled trial of a multilevel physical activity intervention for low income public housing residents. BMC Public Health. 2023 Aug 31;23(1):1676. doi: 10.1186/s12889-023-16574-y.

  PMID: 37653386 DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lisa M Quintiliani, PhD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 7, 2021
• Study Start: May 2, 2022
• Primary Completion: March 17, 2026
• Study Completion: March 18, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)