Peer Empowerment Program for Physical Activity in Low Income and Minority Seniors (PEP4PA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02405325|
Recruitment Status : Active, not recruiting
First Posted : April 1, 2015
Last Update Posted : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity||Behavioral: Physical Activity||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||476 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||PEP4PA - Peer Empowerment Program for Physical Activity in Low Income and Minority Seniors|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
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.
Behavioral: Physical Activity
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.
No Intervention: Usual Care
Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
- Minutes of physical activity as measured by accelerometer [ Time Frame: 12 months ]Change in minutes of MVPA and percentage of participants achieving 150 minutes of PA, per week at 6 and 12 months
- Blood pressure as measured by portable cuff [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405325
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92093|