NCT02405325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
476

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 29, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

4.7 years

First QC Date

March 20, 2015

Results QC Date

June 17, 2021

Last Update Submit

July 9, 2021

Conditions

Keywords

physical activitymultilevelcost-effectivenessolder adults

Outcome Measures

Primary Outcomes (1)

  • Minutes of Physical Activity as Measured by Accelerometer

    Change in minutes of MVPA

    12 months

Study Arms (2)

Physical Activity

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point.

Interventions

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.

Physical Activity

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (2)

  • 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.

    PMID: 28720079BACKGROUND
  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Loki Natarajan
Organization
UCSD

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2015

First Posted

April 1, 2015

Study Start

July 1, 2015

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

July 29, 2021

Results First Posted

July 29, 2021

Record last verified: 2021-07

Locations