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Tufts University

Status

Active, not recruiting

Conditions

Physical Inactivity

Treatments

Other: Environment program
Other: eHealth phone program

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05147298
1R01MD015165-01A1 (U.S. NIH Grant/Contract)
H-42219

Details and patient eligibility

About

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.

Enrollment

543 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

543 participants in 4 patient groups

Environmental group intervention (E only)
Experimental group
Description:
Changing the environment surrounding the PHDs making it more amenable to walking and advocating for changes to the built environment
Treatment:
Other: Environment program
Individual-level eHealth phone program intervention (I only)
Experimental group
Description:
An automated telephone-based physical activity program.
Treatment:
Other: eHealth phone program
Combined group (E and I interventions)
Experimental group
Description:
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.
Treatment:
Other: eHealth phone program
Other: Environment program
Control group (no interventions)
No Intervention group
Description:
No interventions for residents to increase activity levels.

Trial contacts and locations

1

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Central trial contact

Lisa M Quintiliani, PhD

Data sourced from clinicaltrials.gov

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