University of South Carolina
Columbia, South Carolina, 29208, United States
NCT Number: NCT07224217
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.
This study is active but is not currently recruiting participants.
18 year–65 year
Male
Interventional
Not applicable
Columbia, South Carolina, 29208, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 12 weeks
Percentage of recruitment rate (screened/enrolled)
Time frame: 12 weeks
Percentage of participants who complete the study
Time frame: 12 weeks
Percentage of coaching calls completed in Immediate condition
Time frame: 12 weeks
Percentage of self-monitoring logs submitted in Immediate condition
Time frame: 12 weeks
Program satisfaction with the 12 week remote program in Immediate condition
Time frame: baseline to 12 weeks
Moderate-vigorous intensity physical activity (minutes/week) assessed by activPAL
Time frame: baseline to 12 weeks
Steps/day assessed by activPAL
Time frame: baseline to 12 weeks
Global Health assessed via PROMIS (t-score)
University of South Carolina
Other
Evaluating a Remotely Delivered Physical Activity Program for Inactive Men in Rural Communities: A Feasibility Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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