Trial Outcomes & Findings for Peer Empowerment Program for Physical Activity in Low Income and Minority Seniors (NCT NCT02405325)

NCT ID: NCT02405325

Last Updated: 2021-07-29

Results Overview

Change in minutes of MVPA

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 476 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2021-07-29

Participant Flow

Participant milestones

Measure	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. 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.	Usual Care Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
Overall Study STARTED	267	209
Overall Study COMPLETED	203	175
Overall Study NOT COMPLETED	64	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Physical Activity n=267 Participants 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.	Usual Care n=209 Participants Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.	Total n=476 Participants Total of all reporting groups
Age, Continuous	70.5 years STANDARD_DEVIATION 8.8 • n=5 Participants	71.5 years STANDARD_DEVIATION 9.1 • n=7 Participants	71 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	215 Participants n=5 Participants	144 Participants n=7 Participants	359 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	65 Participants n=7 Participants	117 Participants n=5 Participants
Race/Ethnicity, Customized White	120 Participants n=5 Participants	177 Participants n=7 Participants	297 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American Black or African American	113 Participants n=5 Participants	4 Participants n=7 Participants	117 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Other	28 Participants n=5 Participants	13 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	47 Participants n=5 Participants	25 Participants n=7 Participants	72 Participants n=5 Participants
Region of Enrollment United States	267 Participants n=5 Participants	209 Participants n=7 Participants	476 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Change in minutes of MVPA

Outcome measures

Measure	Physical Activity n=267 Participants 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.	Usual Care n=209 Participants 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	20.0 Minutes Interval 16.1 to 23.9	19.2 Minutes Interval 15.5 to 23.0

Adverse Events

Physical Activity

Serious events: 85 serious events

Other events: 149 other events

Deaths: 3 deaths

Usual Care

Serious events: 41 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Measure	Physical Activity n=267 participants at risk 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.	Usual Care n=209 participants at risk Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
General disorders Serious physical injury	3.7% 10/267 • Number of events 11 • 2 years Non-SAEs were not collected in a way that they can be separated.	2.4% 5/209 • Number of events 5 • 2 years Non-SAEs were not collected in a way that they can be separated.
General disorders Fall	7.9% 21/267 • Number of events 26 • 2 years Non-SAEs were not collected in a way that they can be separated.	3.8% 8/209 • Number of events 8 • 2 years Non-SAEs were not collected in a way that they can be separated.
General disorders Prolonged hospitalization for any reason	20.2% 54/267 • Number of events 71 • 2 years Non-SAEs were not collected in a way that they can be separated.	13.4% 28/209 • Number of events 36 • 2 years Non-SAEs were not collected in a way that they can be separated.

Other adverse events

Measure	Physical Activity n=267 participants at risk 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.	Usual Care n=209 participants at risk Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.
General disorders Other adverse event	55.8% 149/267 • Number of events 311 • 2 years Non-SAEs were not collected in a way that they can be separated.	29.2% 61/209 • Number of events 131 • 2 years Non-SAEs were not collected in a way that they can be separated.

Additional Information

Loki Natarajan

UCSD

Phone: 8588224763

Email: lnatarajan@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place