Clinical trial NCT02405325: Peer Empowerment Program for Physical Activity in Low Income and Minority Seniors
Official title: PEP4PA - Peer Empowerment Program for Physical Activity in Low Income and Minority Seniors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: physical activity
multilevel
cost-effectiveness
older adults
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-04-01
Enrollment: 476
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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)

Primary outcomes:
measure: Minutes of Physical Activity as Measured by Accelerometer
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
citation: 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.
citation: 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.