Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Loki Natarajan, University of California, San Diego

Brief Summary:
Older adults are the least active population group in the US. Yet, research has shown that an increase in physical activity (PA) can have immediate and profound effects on cardiovascular health. Older adults who are active use significantly fewer health care resources, and with the increasing number of older adults in the US it is imperative to curb health care expenditure in this group. PEP4PA (Peer Empowerment Program 4 Physical Activity) is a multilevel intervention aimed at increasing physical activity levels in a population of low income and ethnically diverse older adults. It will be delivered in centers by trained older adults. Participants will work towards a daily increase of 2000 steps per day through self-paced incidental walking, peer led group walks, and attendance at existing center PA classes. They will also work on projects to increase opportunities to be physically active at their center or in the surrounding neighborhood.

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Physical Activity Not Applicable

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Blood pressure as measured by portable cuff [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  1. are younger than 50 years,
  2. have had a fall that resulted in a hospitalization in the last 12 months,
  3. cannot complete the walking test within 30 seconds,
  4. are not able to read and write in English,
  5. cannot walk without human assistance
  6. unable to wear study devices and complete assessments,
  7. unable to complete written surveys without assistance,
  8. cannot regularly attend study activities at the center,
  9. are not able to provide written informed consent,
  10. do not adequately answer questions on the post consent test,
  11. Participated in the Community of Mine research study (UCSD)

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)

Publications:
Layout table for additonal information
Responsible Party: Loki Natarajan, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02405325     History of Changes
Other Study ID Numbers: 150336
R01HL125405 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

Keywords provided by Loki Natarajan, University of California, San Diego:
physical activity
multilevel
cost-effectiveness
older adults