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

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT02405325
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 476
• Location: 1
• Arms: 2
• Actual Duration (Months): 56.5
• Patients Per Site Per Month: 8.4

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jul 1, 2015
• Actual Primary Completion Date: Mar 17, 2020
• Actual Study Completion Date: Mar 17, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Minutes of Physical Activity as Measured by Accelerometer [12 months]

   Change in minutes of MVPA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 7, 2020
• Statistical Analysis Plan - Oct 7, 2020

More Information

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.

• Responsible Party: Loki Natarajan, Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT02405325
• Other Study ID Numbers: 150336; R01HL125405
• First Posted: Apr 1, 2015
• Last Update Posted: Jul 29, 2021
• Last Verified: Jul 1, 2021

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

Study Results

Participant Flow

Arm/Group Title	Physical Activity	Usual Care
Arm/Group Description	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. 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.	Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
Period Title: Overall Study
STARTED	267	209
COMPLETED	203	175
NOT COMPLETED	64	34

Baseline Characteristics

Arm/Group Title	Physical Activity	Usual Care	Total
Arm/Group Description	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. 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.	Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.	Total of all reporting groups
Overall Participants	267	209	476
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.5 (8.8)	71.5 (9.1)	71 (8.9)
Sex: Female, Male (Count of Participants)
Female	215 80.5%	144 68.9%	359 75.4%
Male	52 19.5%	65 31.1%	117 24.6%
Race/Ethnicity, Customized (Count of Participants)
White	120 44.9%	177 84.7%	297 62.4%
Black or African American Black or African American	113 42.3%	4 1.9%	117 24.6%
Asian	6 2.2%	15 7.2%	21 4.4%
Other	28 10.5%	13 6.2%	41 8.6%
Hispanic	47 17.6%	25 12%	72 15.1%
Region of Enrollment (Count of Participants)
United States	267 100%	209 100%	476 100%

Outcome Measures

1. Primary Outcome

Title	Minutes of Physical Activity as Measured by Accelerometer
Description	Change in minutes of MVPA
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physical Activity	Usual Care
Arm/Group Description	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. 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.	Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
Measure Participants	267	209
Mean (95% Confidence Interval) [Minutes]	20.0	19.2

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	Non-SAEs were not collected in a way that they can be separated.
Arm/Group Title	Physical Activity		Usual Care
Arm/Group Description	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. 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.		Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
All Cause Mortality
	Physical Activity		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/267 (1.1%)		0/209 (0%)
Serious Adverse Events
	Physical Activity		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	85/267 (31.8%)		41/209 (19.6%)
General disorders
Serious physical injury	10/267 (3.7%)	11	5/209 (2.4%)	5
Fall	21/267 (7.9%)	26	8/209 (3.8%)	8
Prolonged hospitalization for any reason	54/267 (20.2%)	71	28/209 (13.4%)	36
Other (Not Including Serious) Adverse Events
	Physical Activity		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	149/267 (55.8%)		61/209 (29.2%)
General disorders
Other adverse event	149/267 (55.8%)	311	61/209 (29.2%)	131

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.