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The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a remote physical activity intervention designed for rural inactive men.
The proposed study is a pilot randomized controlled trial that will randomize participants to either 1) Immediate intervention, which consists of a 12-week physical activity program or 2) Delayed Intervention, which participants will be assigned to a 6-week abridged version of the program at the end of 12 weeks. Both versions of the physical activity program will provide participants a platform to report their exercise weekly, behavioral lessons, and receive personalized feedback on activity levels. The primary endpoint is to examine the feasibility and acceptability of the 12-week program by evaluating recruitment and retention rates, completion of phone calls, adherence to physical activity self-monitoring, and program satisfaction at 12-weeks. Preliminary efficacy will be assessed by changes in moderate-vigorous physical activity (MVPA), steps/day, health-related quality of life, self-efficacy, self-regulation, and supportive accountability at the end of 12-weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate | Experimental | Receive intervention immediately after randomization |
|
| Delayed | Other | Start intervention after 12 week assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Physical Activity Program (12 weeks) | Behavioral | Participants will receive a 12 week remotely delivered physical activity program immediately after randomization. Participants will receive bi-weekly calls, behavioral lessons, and bi-weekly behavioral feedback via email. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of recruitment | Percentage of recruitment rate (screened/enrolled) | 12 weeks |
| Retention | Percentage of participants who complete the study | 12 weeks |
| Adherence to coaching calls | Percentage of coaching calls completed in Immediate condition | 12 weeks |
| Adherence to self-monitoring | Percentage of self-monitoring logs submitted in Immediate condition | 12 weeks |
| Acceptability | Program satisfaction with the 12 week remote program in Immediate condition | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity - Moderate to vigorous minutes/week | Moderate-vigorous intensity physical activity (minutes/week) assessed by activPAL | baseline to 12 weeks |
| Physical activity - Steps | Steps/day assessed by activPAL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine A Pellegrini, PhD | University of South Carolina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29208 | United States |
IPD will be shared on request to the PI
IPD will be available on request after outcomes have been published
IPD will be available on request after outcomes have been published
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| Delayed Remote Physical Activity Program (6 weeks) | Behavioral | Participants receive a 6 week remote physical activity program after completing the 12 week assessment. The program includes weekly calls, behavioral lessons, and weekly behavioral feedback via email. |
|
| baseline to 12 weeks |
| Global Health | Global Health assessed via PROMIS (t-score) | baseline to 12 weeks |