Remote Exercise Program for Rural Men
Evaluating a Remotely Delivered Physical Activity Program for Inactive Men in Rural Communities: A Feasibility Study
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate
Receive intervention immediately after randomization |
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. |
|
Other: Delayed
Start intervention after 12 week assessment |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of recruitment
Time Frame: 12 weeks
|
Percentage of recruitment rate (screened/enrolled) |
12 weeks
|
|
Retention
Time Frame: 12 weeks
|
Percentage of participants who complete the study |
12 weeks
|
|
Adherence to coaching calls
Time Frame: 12 weeks
|
Percentage of coaching calls completed in Immediate condition |
12 weeks
|
|
Adherence to self-monitoring
Time Frame: 12 weeks
|
Percentage of self-monitoring logs submitted in Immediate condition |
12 weeks
|
|
Acceptability
Time Frame: 12 weeks
|
Program satisfaction with the 12 week remote program in Immediate condition |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity - Moderate to vigorous minutes/week
Time Frame: baseline to 12 weeks
|
Moderate-vigorous intensity physical activity (minutes/week) assessed by activPAL |
baseline to 12 weeks
|
|
Physical activity - Steps
Time Frame: baseline to 12 weeks
|
Steps/day assessed by activPAL |
baseline to 12 weeks
|
|
Global Health
Time Frame: baseline to 12 weeks
|
Global Health assessed via PROMIS (t-score) |
baseline to 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Christine A Pellegrini, PhD, University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000136
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD will be shared on request to the PI
IPD Sharing Time Frame
IPD will be available on request after outcomes have been published
IPD Sharing Access Criteria
IPD will be available on request after outcomes have been published
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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