Remote Exercise Program for Rural Men

NCT ID: NCT07224217

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rural Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immediate

Receive intervention immediately after randomization

Group Type EXPERIMENTAL

Remote Physical Activity Program (12 weeks)

Intervention Type 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

Start intervention after 12 week assessment

Group Type OTHER

Delayed Remote Physical Activity Program (6 weeks)

Intervention Type 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.

Interventions

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Remote 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.

Intervention Type BEHAVIORAL

Delayed 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Christine A Pellegrini, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine A Pellegrini, PhD

Role: STUDY_DIRECTOR

University of South Carolina

Locations

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University of South Carolina

Columbia, South Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Scott Jamieson

Role: CONTACT

803-777-9236

Christine Pellegrini, PhD

Role: CONTACT

803-777-0911

Facility Contacts

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Scott Jamieson

Role: primary

803-777-9236

Other Identifiers

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STUDY00000136

Identifier Type: -

Identifier Source: org_study_id

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