Physical Activity Intervention Tailored for Rural Men
1 other identifier
interventional
40
1 country
1
Brief Summary
The goal of this project is to develop a scalable physical activity intervention tailored to rural men. We will recruit participants nationwide from ResearchMatch data base, emails, and social media posts. Participants will have access to health education materials hosted on Healthie, a health coaching software platform, and provided an activity monitor (e.g., Fitbit) to support behavior change. The health education materials provide participants with education, motivation, and support for making health behavior change (e.g., increasing physical activity levels). We will measure physical activity behaviors, psychosocial, and several health outcomes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
July 15, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2023
CompletedFebruary 21, 2023
February 1, 2023
6 months
July 7, 2022
February 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical Activity (average steps per day)
Examining the activity levels of participants using the average steps per day from the Fitbit device. The average steps per day taken during baseline (Week 0) will be compared to average steps per day during post-intervention testing (Week 11).
Measurements taken from Baseline (Week 0) to post-intervention (Week 11)
Secondary Outcomes (8)
Muscular Strength
Measurements taken from Baseline (Week 0) to post-intervention (Week 11)
Attitude towards physical activity (self-report)
Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Perceived capability over physical activity (self-reported)
Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Perceived opportunity for physical activity (self-reported)
Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Behavioral regulation for physical activity (self-reported)
Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
- +3 more secondary outcomes
Study Arms (1)
Intervention Group
EXPERIMENTALParticipants receive a Fitbit and access to a 10 week educational course that accessible through the web or app. While participants can complete the program at their own pace, there is a suggested schedule with 1-2 modules/lessons completed per week. Each module has a different topic related to promoting adoption and maintenance of physical activity.
Interventions
The participants receive lessons on the physical activity guidelines, goal setting, physical activity planning, habit development, identity formation, and how to apply all these tools together. In addition, there are numerous resources provided to other existing web resources, including exercise videos and other informational webpages (e.g., USDA nutritional recommendations).
Eligibility Criteria
You may qualify if:
- Have a smart phone capable of sending/receiving test messages
- Currently inactive (\<75 minutes of moderate-vigorous activity per week)
- Identify as male
- Live in a rural community
- Intending to be more active
You may not qualify if:
- Not able to safely increase physical activity
- Cannot commit to a 10 week program
- Have a surgery planned in 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jacob Gallagherlead
- Iowa State Fraternal Order of Eaglescollaborator
Study Sites (1)
Field House
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Graduate Fellow
Study Record Dates
First Submitted
July 7, 2022
First Posted
July 15, 2022
Study Start
August 1, 2022
Primary Completion
January 20, 2023
Study Completion
January 20, 2023
Last Updated
February 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- The data will become available within 6 months after related publications.
- Access Criteria
- Data will be made available using a repository at the University of Iowa. This data will be available to use for replication of results, and secondary analysis.
All data related to the primary outcome will be shared.