Remote Exercise Program for Rural Men

N/AActive Not RecruitingNCT07224217

University of South Carolina37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Rural Health

Interventions

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.

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of South Carolina

Columbia, South Carolina, United States

Outcomes

Primary Outcomes

Feasibility of recruitment

Percentage of recruitment rate (screened/enrolled)

Time frame: 12 weeks

Retention

Percentage of participants who complete the study

Time frame: 12 weeks

Adherence to coaching calls

Percentage of coaching calls completed in Immediate condition

Time frame: 12 weeks

Adherence to self-monitoring

Percentage of self-monitoring logs submitted in Immediate condition

Time frame: 12 weeks

Acceptability

Program satisfaction with the 12 week remote program in Immediate condition

Time frame: 12 weeks

Secondary Outcomes

Physical activity - Moderate to vigorous minutes/week

Moderate-vigorous intensity physical activity (minutes/week) assessed by activPAL

Time frame: baseline to 12 weeks

Physical activity - Steps

Steps/day assessed by activPAL

Time frame: baseline to 12 weeks

Global Health

Global Health assessed via PROMIS (t-score)

Time frame: baseline to 12 weeks

Data from ClinicalTrials.gov

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