Physical InactivityNCT05147298
Community Walks: Clinical Trial
A study testing eHealth phone program and Environment program in people with Physical Inactivity, run by Tufts Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- eHealth phone program and Environment program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 543 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 18 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Multilevel Physical Activity Intervention for Low Income Public Housing Residents
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
- Being tested
- eHealth phone program, Environment program
- Keywords
- Public housing developments (PHDs), Environmental level interventions, Individual level interventions, eHealth phone program, Healthy living advocates
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth phone programOther
The automated eHealth phone program uses text to speech technology to deliver educational content to increase awareness, confidence, and motivation for physical activity.
Environment programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Environment program |
| Individual-level eHealth phone program intervention (I only) | Experimental | An automated telephone-based physical activity program. Receives: 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. Receives: Other: eHealth phone program; Other: Environment program |
| Control group (no interventions) | No intervention | No interventions for residents to increase activity levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: baseline, 24 months
Secondary outcomes (5)
Evaluate the mediator effects of motivation
This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire.
Measured: baseline, 12 months, 24 months
Evaluate the mediator effects of self-efficacy
This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire.
Measured: baseline, 12 months, 24 months
Evaluate the mediator effects of neighborhood walkability
This outcome will be assessed by analyzing participants' responses to relevant questions in an Investigator developed questionnaire.
Measured: baseline, 12 months, 24 months
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.
Measured: baseline, 12 months, 24 months
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.
Measured: baseline, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start2 May 2022
- Primary completion17 Mar 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Lisa M Quintiliani, PhD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147298
- Sponsor's protocol ID
- H-42219
- Other IDs
- 1R01MD015165-01A1
- Status last verified
- Apr 2026
- First submitted
- 24 Nov 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37653386
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Physical Activity Intervention for Low Income Public Housing Residents
- ClinicalTrials.gov ID
- NCT05147298
- Acronym / sponsor ID
- H-42219
- Conditions
- Physical Inactivity
- Keywords
- Public housing developments (PHDs), Environmental level interventions, Individual level interventions, eHealth phone program, Healthy living advocates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 2 May 2022 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Environmental group intervention (E only) | Experimental | Other: Environment programChanging the environment surrounding the PHDs making it more amenable to walking and advocating for changes to the built environment |
| Individual-level eHealth phone program intervention (I only) | Experimental | Other: eHealth phone programAn automated telephone-based physical activity program. |
| Combined group (E and I interventions) | Experimental | Other: eHealth phone program, Other: Environment programChanging 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. |
| Control group (no interventions) | No intervention | –No interventions for residents to increase activity levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth phone programThe automated eHealth phone program uses text to speech technology to deliver educational content to increase awareness, confidence, and motivation for physical activity. | Other | Combined group (E and I interventions), Individual-level eHealth phone program intervention (I only) |
| Environment programThe 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. | Other | Combined group (E and I interventions), Environmental group intervention (E only) |
Primary outcome
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).
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).
5 secondary outcomes
Evaluate the mediator effects of motivation
Time frame: baseline, 12 months, 24 months
Evaluate the mediator effects of self-efficacy
Time frame: baseline, 12 months, 24 months
Evaluate the mediator effects of neighborhood walkability
Time frame: baseline, 12 months, 24 months
Evaluate the mediator effects of support from HLAs
Time frame: baseline, 12 months, 24 months
Evaluate the mediator effects fidelity to the interventions
Time frame: baseline, 12 months, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 37653386Quintiliani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Quintiliani, PhD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth phone program and Environment program in people with Physical Inactivity, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in minutes of light, moderate, and vigorous intensity physical activity per day at 12 months (time frame: baseline, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05147298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.