- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405325
Peer Empowerment Program for Physical Activity in Low Income and Minority Seniors (PEP4PA)
PEP4PA - Peer Empowerment Program for Physical Activity in Low Income and Minority Seniors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In a 2-year cluster randomized controlled field trial of 408 ethnically diverse, older adults (50+ years old) in 12 low income community centers serving seniors in San Diego County the investigators will investigate:
- The efficacy of PEP4PA (Peer Empowerment Program 4 Physical Activity) to reduce disparities in PA by increasing the percentage of participants achieving 150 minutes of PA per week at 6 and 12 months. Hypothesis: Participants in PEP4PA will significantly increase PA minutes in moderate intensity (measured objectively by accelerometry) to a greater extent than older adults receiving usual care (e.g. normal PA programing) in control centers and a greater percent will meet NHANES criteria for weekly PA.
- The efficacy of PEP4PA to improve physical functioning, blood pressure (BP), depressive symptoms and quality of life. Hypothesis: Participants in PEP4PA will significantly increase their physical functioning (measured objectively by the short physical performance battery and 6 minute timed walk), decrease their systolic BP (mmHg) and reporting of depressive symptoms, and improve their quality of life scores (measured at baseline, 6 & 12 months) to a greater extent than older adults in control centers.
- Assess the incremental cost effectiveness ratio (ICER) of PEP4PA in terms of cost per MET hour and cost per QALY compared to usual programming in the control centers at 12 months.
- Evaluate the impact of PEP4PA on secondary outcomes such as sedentary time and sleep quality (measured by accelerometry), cognitive/executive functioning, and walking routes (from GPS) at 12 months.
Exploratory aims: 5. Examine individual, interpersonal, organizational, and environmental factors that affect implementation & behavior change. 6. Assess the efficacy, effectiveness and ICER of PEP4PA at 24 months
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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La Jolla, California, United States, 92093
- University of California, San Diego
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- are 50 years or older
- have not had a fall that resulted in a hospitalization in the past 12 months
- able to complete a 3 meter walking test within 30 seconds
- able to read and write in English
- able to walk without assistance from another person
- able to wear study devices and complete assessments
- able to complete written surveys without assistance
- able to attend regular study activities at the center
- able to provide written informed consent and complete a post consent comprehension assessment
- able to commit approximately 10 hours per week to study activities (peer Health Coach only)
- active for 20 minutes per day on at least 3 days per week (peer Health Coach only)
Exclusion Criteria:
- are younger than 50 years,
- have had a fall that resulted in a hospitalization in the last 12 months,
- cannot complete the walking test within 30 seconds,
- are not able to read and write in English,
- cannot walk without human assistance
- unable to wear study devices and complete assessments,
- unable to complete written surveys without assistance,
- cannot regularly attend study activities at the center,
- are not able to provide written informed consent,
- do not adequately answer questions on the post consent test,
- Participated in the Community of Mine research study (UCSD)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Physical Activity
The program will be run by peer Leaders and senior center staff with the support of UCSD staff.
Participants will work towards a 2000 increase in daily steps through self-paced incidental walking and peer led group walks.
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intervention activities will remain at the daily level, including using pedometers, having daily goals, attendance at Peer lead group walks and recognition of efforts through monthly celebrations and bi-weekly goal tracking with peer Health Coaches.
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No Intervention: Usual Care
Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minutes of Physical Activity as Measured by Accelerometer
Time Frame: 12 months
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Change in minutes of MVPA
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12 months
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Rich P, Aarons GA, Takemoto M, Cardenas V, Crist K, Bolling K, Lewars B, Sweet CC, Natarajan L, Shi Y, Full KM, Johnson E, Rosenberg DE, Whitt-Glover M, Marcus B, Kerr J. Implementation-effectiveness trial of an ecological intervention for physical activity in ethnically diverse low income senior centers. BMC Public Health. 2017 Jul 18;18(1):29. doi: 10.1186/s12889-017-4584-1. Erratum In: BMC Public Health. 2017 Sep 22;17 (1):736.
- Crist K, Full KM, Linke S, Tuz-Zahra F, Bolling K, Lewars B, Liu C, Shi Y, Rosenberg D, Jankowska M, Benmarhnia T, Natarajan L. Health effects and cost-effectiveness of a multilevel physical activity intervention in low-income older adults; results from the PEP4PA cluster randomized controlled trial. Int J Behav Nutr Phys Act. 2022 Jun 27;19(1):75. doi: 10.1186/s12966-022-01309-w.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 150336
- R01HL125405 (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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