Physical Activity
Conditions
Keywords
physical activity, multilevel, cost-effectiveness, older adults
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
Interventions
BEHAVIORALPhysical 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minutes of Physical Activity as Measured by Accelerometer | 12 months | Change in minutes of MVPA |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 267 |
| Usual Care Measurement at baseline, 6, 12, 18 and 24 months only with a health related event at each time point. | 209 |
| Total | 476 |
Baseline characteristics
| Characteristic | Physical Activity | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 70.5 years STANDARD_DEVIATION 8.8 | 71.5 years STANDARD_DEVIATION 9.1 | 71 years STANDARD_DEVIATION 8.9 |
| Race/Ethnicity, Customized Asian | 6 Participants | 15 Participants | 21 Participants |
| Race/Ethnicity, Customized Black or African American Black or African American | 113 Participants | 4 Participants | 117 Participants |
| Race/Ethnicity, Customized Hispanic | 47 Participants | 25 Participants | 72 Participants |
| Race/Ethnicity, Customized Other | 28 Participants | 13 Participants | 41 Participants |
| Race/Ethnicity, Customized White | 120 Participants | 177 Participants | 297 Participants |
| Region of Enrollment United States | 267 Participants | 209 Participants | 476 Participants |
| Sex: Female, Male Female | 215 Participants | 144 Participants | 359 Participants |
| Sex: Female, Male Male | 52 Participants | 65 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 267 | 0 / 209 |
| other Total, other adverse events | 149 / 267 | 61 / 209 |
| serious Total, serious adverse events | 85 / 267 | 41 / 209 |
Outcome results
Primary
Minutes of Physical Activity as Measured by Accelerometer
Change in minutes of MVPA
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity | Minutes of Physical Activity as Measured by Accelerometer | 20.0 Minutes |
| Usual Care | Minutes of Physical Activity as Measured by Accelerometer | 19.2 Minutes |