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Peer Empowerment Program for Physical Activity in Low Income and Minority Seniors (PEP4PA)

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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

Tracking Information
First Submitted Date  ICMJE March 20, 2015
First Posted Date  ICMJE April 1, 2015
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE July 2015
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
Minutes of physical activity as measured by accelerometer [ Time Frame: 12 months ]
percentage of participants achieving 150 minutes of PA per week at 6 and 12 months
Change History Complete list of historical versions of study NCT02405325 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
Blood pressure as measured by portable cuff [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
  • Physical functioning as measured by the Short Physical Performance Battery (SPPB) [ Time Frame: 12 months ]
  • Blood pressure as measured by portable cuff [ Time Frame: 12 months ]
  • depressive symptoms as measured by CES-D [ Time Frame: 12 months ]
  • cognitive functioning as measured by Trail Making Test A and B [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peer Empowerment Program for Physical Activity in Low Income and Minority Seniors
Official Title  ICMJE PEP4PA - Peer Empowerment Program for Physical Activity in Low Income and Minority Seniors
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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Physical Activity
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Physical Activity
  • No Intervention: Usual Care
    Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 27, 2018)
476
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2015)
408
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02405325
Other Study ID Numbers  ICMJE 150336
R01HL125405 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Loki Natarajan, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE Not Provided
PRS Account University of California, San Diego
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP