NCT07224217

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

October 31, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

physical activitybehavioral interventionRural men

Outcome Measures

Primary Outcomes (5)

  • Feasibility of recruitment

    Percentage of recruitment rate (screened/enrolled)

    12 weeks

  • Retention

    Percentage of participants who complete the study

    12 weeks

  • Adherence to coaching calls

    Percentage of coaching calls completed in Immediate condition

    12 weeks

  • Adherence to self-monitoring

    Percentage of self-monitoring logs submitted in Immediate condition

    12 weeks

  • Acceptability

    Program satisfaction with the 12 week remote program in Immediate condition

    12 weeks

Secondary Outcomes (3)

  • Physical activity - Moderate to vigorous minutes/week

    baseline to 12 weeks

  • Physical activity - Steps

    baseline to 12 weeks

  • Global Health

    baseline to 12 weeks

Study Arms (2)

Immediate

EXPERIMENTAL

Receive intervention immediately after randomization

Behavioral: Remote Physical Activity Program (12 weeks)

Delayed

OTHER

Start intervention after 12 week assessment

Behavioral: Delayed Remote Physical Activity Program (6 weeks)

Interventions

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.

Immediate

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.

Delayed

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christine A Pellegrini, PhD

    University of South Carolina

    STUDY DIRECTOR

Central Study Contacts

Scott Jamieson

CONTACT

Christine Pellegrini, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 31, 2025

First Posted

November 4, 2025

Study Start

November 1, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

IPD will be shared on request to the PI

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
IPD will be available on request after outcomes have been published
Access Criteria
IPD will be available on request after outcomes have been published

Locations