- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01025726
Positive Action for Today's Health (PATH)
January 17, 2023 updated by: Dawn Wilson, University of South Carolina
Improving Safety and Access for Physical Activity
Regular moderate and vigorous intensity physical activity (PA) is inversely related with obesity, however, few adults are successful in incorporating sufficient PA into their daily lives.
Minority and lower-income adults have among the highest obesity rates and lowest levels of regular PA.
Increasing environmental supports for safe and convenient places for PA is an emerging public health strategy for PA interventions.
Preliminary data by Wilson (PI) and colleagues has revealed through focus groups that low-income minority adults would like to increase the safe places for PA (areas free from crime, containment of stray dogs, increased police patrol) and access to PA (sidewalks/trails and expand opportunities for PA) in their community.
In addition, the results of the investigators' preliminary studies suggest that African Americans had psychosocial barriers to PA that included lack of self-motivation, cultural body image issues, and lack of time due to family obligations.
The present proposal is innovative in that it specifically tests the efficacy of an intervention that includes both patrolled-walking and social marketing elements to increase PA in low-income African Americans.
Three communities will be randomized to receive one of three programs: a police patrolled-walking program plus social marketing intervention, a police patrolled-walking only intervention, or no walking intervention (general health education only; N=390; 130/group).
The 24-month intervention will focus on increasing safety (training community leaders to serve as walking captains, hiring off-duty police officers to patrol the walking program, and containing stray dogs), increasing access for PA (marking a walking route), and will include a tailored social marketing campaign for increasing PA (in one intervention community).
The investigators will collect data for PA (7-day accelerometer estimates, 4-week PA history), body composition, blood pressure, psychosocial measures, and perceptions of environmental supports for safety and access for PA at baseline, 6-,12-,18-, and 24-months.
The primary hypotheses are that the patrolled-walking plus social marketing intervention will result in greater increases in moderate and vigorous PA as compared to a patrolled walking only intervention or no-intervention by 12-months and that these effects will be maintained at 18-month and 24-month assessments.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
439
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
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Florence, South Carolina, United States, 29506
- Pee Dee CAP Weed & Seed
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Orangeburg, South Carolina, United States, 29115
- Ministry of Reconcilliation
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Sumter, South Carolina, United States, 29150
- M.H. Newton Family Life Enrichment Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- African American (3 of 4 grandparents are of African Descent)
- Lives in designated census area
- No plans to move in the next two years
- Has no medical condition that would limit participation in moderate intensity exercise including life-threatening illness (e.g., immobile, severely disabled, or bed ridden)
- Available and able to participate in measures and intervention activities over the next 2 years
Exclusion Criteria:
- Extreme Blood Pressure and/or Blood Glucose levels
- Unable to take a brisk, 30-minute walk
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Full Intervention
Police Patrolled Walking Program plus Social Marketing Intervention
|
Identify walking route, hire walking leaders and police support, maintain route and monitor stray dogs PLUS grass-roots social marketing campaign to promote walking on the route
|
Experimental: Walking Only
Police Patrolled Walking Only Intervention
|
Identify walking route, hire walking leaders and police support, maintain route and monitor stray dogs
|
Active Comparator: General Health
General Health Education Intervention
|
Host community events for chronic disease education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physical Activity (Accelerometer)
Time Frame: 0, 6, 12, 18, 24 months
|
0, 6, 12, 18, 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood Pressure
Time Frame: 0, 6, 12, 18, 24 months
|
0, 6, 12, 18, 24 months
|
Body Mass Index (BMI)
Time Frame: 0, 6, 12, 18, 24 months
|
0, 6, 12, 18, 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dawn K Wilson, PhD, University of South Carolina
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McDaniel T, Wilson DK, Coulon MS, Sweeney AM, Van Horn ML. Interaction of Neighborhood and Genetic Risk on Waist Circumference in African-American Adults: A Longitudinal Study. Ann Behav Med. 2021 Jul 22;55(8):708-719. doi: 10.1093/abm/kaaa063.
- Abshire DA, Wilson DK, Sweeney AM, Pinto BM. Correlates of Moderate-to-Vigorous Physical Activity and Exercise Motivation in Underserved African American Men. Am J Mens Health. 2019 May-Jun;13(3):1557988319855155. doi: 10.1177/1557988319855155.
- Sweeney AM, Wilson DK, Lee Van Horn M. Longitudinal relationships between self-concept for physical activity and neighborhood social life as predictors of physical activity among older African American adults. Int J Behav Nutr Phys Act. 2017 May 22;14(1):67. doi: 10.1186/s12966-017-0523-x.
- Wilson DK, Van Horn ML, Siceloff ER, Alia KA, St George SM, Lawman HG, Trumpeter NN, Coulon SM, Griffin SF, Wandersman A, Egan B, Colabianchi N, Forthofer M, Gadson B. The Results of the "Positive Action for Today's Health" (PATH) Trial for Increasing Walking and Physical Activity in Underserved African-American Communities. Ann Behav Med. 2015 Jun;49(3):398-410. doi: 10.1007/s12160-014-9664-1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
December 1, 2009
First Submitted That Met QC Criteria
December 2, 2009
First Posted (Estimate)
December 3, 2009
Study Record Updates
Last Update Posted (Estimate)
January 19, 2023
Last Update Submitted That Met QC Criteria
January 17, 2023
Last Verified
September 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- Pro00005110
- R01DK067615 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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