Rural Health
Conditions
Keywords
physical activity, behavioral intervention, Rural men
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALRemote Physical Activity Program (12 weeks)
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.
BEHAVIORALDelayed Remote Physical Activity Program (6 weeks)
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.
Sponsors
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Identify biological sex as male * Engage in less than 90 minutes of self-reported moderate intensity exercise * Ability to read and write in English * Primarily living in a rural jurisdiction defined by 1 of the 7 more widely used definitions of rurality by the United States government * Ability to walk independently for at least one block
Exclusion criteria
* Have a medical condition that could be made worse with a change in physical activity * Plans to relocate from primary residence within 3 months of signing up for study * Not willing to wear physical activity monitor for 7 days or complete surveys * Less than 4 valid days of activity monitor wear time at baseline assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of recruitment | 12 weeks | Percentage of recruitment rate (screened/enrolled) |
| Retention | 12 weeks | Percentage of participants who complete the study |
| Adherence to coaching calls | 12 weeks | Percentage of coaching calls completed in Immediate condition |
| Adherence to self-monitoring | 12 weeks | Percentage of self-monitoring logs submitted in Immediate condition |
| Acceptability | 12 weeks | Program satisfaction with the 12 week remote program in Immediate condition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity - Moderate to vigorous minutes/week | baseline to 12 weeks | Moderate-vigorous intensity physical activity (minutes/week) assessed by activPAL |
| Physical activity - Steps | baseline to 12 weeks | Steps/day assessed by activPAL |
| Global Health | baseline to 12 weeks | Global Health assessed via PROMIS (t-score) |
Countries
United States
Contacts
STUDY_DIRECTORChristine A Pellegrini, PhD
University of South Carolina
Outcome results
None listed