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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL125405 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual Care | No Intervention | Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Minutes of Physical Activity as Measured by Accelerometer | Change in minutes of MVPA | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28720079 | Background | 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. | |
| 35761363 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Minutes of Physical Activity as Measured by Accelerometer | Change in minutes of MVPA | Posted | Mean | 95% Confidence Interval | Minutes | 12 months |
|
2 years
Non-SAEs were not collected in a way that they can be separated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious physical injury | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other adverse event | General disorders | Non-systematic Assessment | Included reports of muscle cramping, joint pain, respiratory issues, infectious disease (i.e. flu) and chronic conditions, etc. for any reason, not related to intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Loki Natarajan | UCSD | 8588224763 | lnatarajan@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2020 | Jul 8, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2020 | Jul 8, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| BG001 | Usual Care | Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
|
| 3 |
| 267 |
| 85 |
| 267 |
| 149 |
| 267 |
| EG001 | Usual Care | Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point. | 0 | 209 | 41 | 209 | 61 | 209 |
| Fall | General disorders | Non-systematic Assessment |
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| Prolonged hospitalization for any reason | General disorders | Non-systematic Assessment |
|
|
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