Community Walks Program for Sedentary Lifestyle

Recruiting at 1 trial location

Overseen By Marislena Amezquita, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts Medical Center

Disqualifiers: Other physical activity study

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

543 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment eHealth phone program, Environment program in the Community Walks Program for Sedentary Lifestyle?

Research shows that eHealth interventions, like those using smartphones, can help improve health outcomes by increasing patient engagement and providing personalized feedback, as seen in studies on blood pressure management and diabetes care. ^{1 2 3 4 5}

Is the Community Walks Program for Sedentary Lifestyle safe for humans?

Research on similar programs, like mobile health-based and lifestyle modification programs, shows they are generally safe for humans, with no serious adverse events reported. ^{6 7 8 9 10}

How does the Community Walks Program for Sedentary Lifestyle differ from other treatments for sedentary behavior?

The Community Walks Program is unique because it combines an eHealth phone program with an environmental approach to encourage physical activity, making it accessible and tailored to community needs. Unlike traditional exercise programs, it focuses on reducing sedentary behavior through community engagement and environmental changes, which have shown promise in promoting sustained behavior change. ^{11 12 13 14 15}

Research Team

Lisa M Quintiliani, PhD

Principal Investigator

Tufts Medical Center

Eligibility Criteria

This trial is for English or Spanish speakers who live in Boston Public Housing or on property owned by the Boston Housing Authority, plan to stay there for at least 2 years, have phone access, and are willing to wear a physical activity tracking device during assessments. It's not for those already in another incompatible physical activity study or unable to consent.

Inclusion Criteria

No plans to move within the next 2 years

I am willing to wear a physical activity tracker.

I can speak English or Spanish.

Exclusion Criteria

I am able to understand and agree to the study's requirements.

Currently enrolled in a research study about physical activity that is incompatible with study participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of environmental and individual-level interventions to promote physical activity

24 months

Ongoing community activities and phone program

Follow-up

Participants are monitored for changes in physical activity levels at 12 and 24 months

24 months

Assessments at 12 and 24 months

Treatment Details

Interventions

• eHealth phone program
• Environment program

Trial Overview The study tests if an environmental program (creating walking trails/maps), community-led walking groups, an eHealth phone program, or both combined can increase moderate intensity physical activity among residents. Participants from different housing developments will be randomly assigned to one of these interventions or a control group with no intervention.

Participant Groups

Group I: Individual-level eHealth phone program intervention (I only) Experimental Treatment 1 Intervention

An automated telephone-based physical activity program.

Group II: Environmental group intervention (E only) Experimental Treatment 1 Intervention

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

Group III: Combined group (E and I interventions) Experimental Treatment 2 Interventions

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.

Group IV: Control group (no interventions) Active Control 1 Intervention

No interventions for residents to increase activity levels.

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

The eHealth intervention was delivered with high fidelity, with 93% of participants receiving initial training and 98.45% of expected follow-ups conducted, indicating strong program adherence.

Despite high engagement from 40.4% of users over 12 months, increased usage did not lead to significant improvements in clinical outcomes or lifestyle changes, suggesting that simply using the intervention more frequently does not guarantee better health results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement. Coorey, G., Peiris, D., Scaria, A., et al.[2021]

Cell phone interventions for individuals with diabetes or obesity have been shown to significantly improve health outcomes, particularly in reducing hemoglobin A1c levels, with 9 out of 10 studies reporting positive results.

These interventions also enhance communication between patients and healthcare providers, leading to greater satisfaction with care and increased self-management skills among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes self-management care via cell phone: a systematic review. Krishna, S., Boren, SA.[2022]

Interventions using wearable activity trackers during hospitalization significantly increased overall physical activity levels and reduced sedentary behavior among 1911 participants across various medical conditions, showing a standardized mean difference of 0.35 for activity and a reduction of 35.46 minutes per day in sedentary time.

Patients using these trackers also experienced improvements in physical function, with a standardized mean difference of 0.27, indicating that these devices can enhance recovery during hospital stays, although they did not significantly affect pain, mental health, length of stay, or readmission rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions Using Wearable Activity Trackers to Improve Patient Physical Activity and Other Outcomes in Adults Who Are Hospitalized: A Systematic Review and Meta-analysis. Szeto, K., Arnold, J., Singh, B., et al.[2023]

A 6-month mobile health (mHealth)-based disease management program significantly reduced both systolic and diastolic blood pressure in 125 participants with hypertension, diabetes, and dyslipidemia, indicating its efficacy for managing vascular disease risk.

The program was found to be safe, with no serious adverse events reported, suggesting it can be a reliable intervention for individuals with multiple lifestyle-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health-Based Disease Management Program Improves Blood Pressure in People With Multiple Lifestyle-Related Diseases at Risk of Developing Vascular Disease - A Retrospective Observational Study. Kanai, M., Toda, T., Yamamoto, K., et al.[2022]

In a low-intensity, employer-sponsored weight loss program involving 3 counseling calls and a comprehensive website, one third of participants lost at least 5% of their body weight after six months, indicating the program's efficacy.

Utilization of both counseling and the website, particularly the weight tracking tool, was linked to successful weight loss, along with positive health behavior changes like increased fruit and vegetable intake and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and utilization of a low intensity workplace weight loss program. Carpenter, KM., Lovejoy, JC., Lange, JM., et al.[2021]

A review of 26 studies found that interventions aimed at reducing sedentary behavior in adults were categorized as very promising (39%), quite promising (21%), and non-promising (39%), with worksite-based interventions being the most common.

The most effective strategies included environmental restructuring and self-monitoring techniques, suggesting that future interventions should focus on modifying environments and enhancing self-regulatory skills to reduce sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults. Gardner, B., Smith, L., Lorencatto, F., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feedback based on health advice via tracing bracelet and smartphone in the management of blood pressure among hypertensive patients: A community-based RCT trial in Chongqing, China. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of exercise intervention in breast cancer patients: is mobile health (mHealth) with pedometer more effective than conventional program using brochure? [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Diabetes self-management care via cell phone: a systematic review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Interventions Using Wearable Activity Trackers to Improve Patient Physical Activity and Other Outcomes in Adults Who Are Hospitalized: A Systematic Review and Meta-analysis. [2023]

6. Japan pubmed.ncbi.nlm.nih.gov

A Mobile Health-Based Disease Management Program Improves Blood Pressure in People With Multiple Lifestyle-Related Diseases at Risk of Developing Vascular Disease - A Retrospective Observational Study. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Physical fitness gains following simple environmental change. [2015]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of a Lifestyle Modification Program Delivered under Real-World Conditions in a Rural Setting. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Outcomes and utilization of a low intensity workplace weight loss program. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Electronic Health Lifestyle Coaching Among Diabetes Patients in a Real-Life Municipality Setting: Observational Study. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Promoting physical activity through community-wide policies and planning: findings from Curitiba, Brazil. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Rural Environments and Community Health (REACH): a randomised controlled trial protocol for an online walking intervention in rural adults. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

What Works and for Whom? Outcome Evaluation of an E-mail Walking Program Delivered Through Cooperative Extension. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Wheeling walks: evaluation of a media-based community intervention. [2022]

15. England pubmed.ncbi.nlm.nih.gov

How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults. [2023]