Physical Activity Intervention Tailored for Rural Men

February 17, 2023 updated by: Jacob Gallagher
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Field House

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not able to safely increase physical activity
  • Cannot commit to a 10 week program
  • Have a surgery planned in 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Participants 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.
Behavioral: No BS just Fitness
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical Activity (average steps per day)
Time Frame: Measurements taken from Baseline (Week 0) to post-intervention (Week 11)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscular Strength
Time Frame: Measurements taken from Baseline (Week 0) to post-intervention (Week 11)
Assessed via a sum score of push-ups (until exhaustion), squat test (number of reps in 60s), and sit-up (reps in 60s)
Measurements taken from Baseline (Week 0) to post-intervention (Week 11)
Attitude towards physical activity (self-report)
Time Frame: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Attitude towards physical activity will be measured using a sum score of Likert scales (1- Extremely disagree to 7-Extremely agree) on 6 questions, asking about participants' belief regarding physical activity (e.g., engaging in physical activity would be enjoyable) - (Rhodes & Courneya, 2003).
Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Perceived capability over physical activity (self-reported)
Time Frame: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Perceived capability over physical activity will measured using a sum score of Likert scales (1- Extremely disagree to 7-Extremely agree) on 3 questions, asking about participants' confidence over engaging in physical activity (e.g., I possess the skill to do regular physical activity if I wanted to) (Rhodes, Blanchard, & Matheson, 2006; Burrell, Allan, Williams, & Jonnston, 2018)
Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Perceived opportunity for physical activity (self-reported)
Time Frame: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Perceived opportunity for physical activity will be measured using a sum score of Likert scales (1- Extremely disagree to 7-Extremely agree) on 3 questions, asking about participants' opportunity to engage in physical activity (e.g., If I really wanted to do regular physical activity, I would have the chance to do so) (Rhodes, Blanchard, & Matheson, 2006; Burrell, Allan, Williams, & Jonnston, 2018)
Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Behavioral regulation for physical activity (self-reported)
Time Frame: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Behavioral regulation for physical activity will be measured using a sum score of Likert scales (1- Extremely disagree to 7-Extremely agree) on 6 questions, asking about participants' strategies used to help them engage in physical activity (e.g., I kept track of my physical activity in a dairy or log over the last month) (Sniehotta, Schwarzer, Scholz, & Shuz, 2005)
Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Habit of physical activity (self-reported)
Time Frame: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Habit of physical activity will be measured as a sum score of Likert scales (1- Extremely disagree to 7-Extremely agree) on 4 questions, asking about participants' habits related to physical activity (e.g., Physical activity is something I do automatically) (Gardner, Abraham, Lally, de Brujin, 2012))
Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Physical activity identity (self-reported)
Time Frame: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Physical activity identity will be measured as a sum score of Likert scales (1- Extremely disagree to 7-Extremely agree) on 4 questions, asking about participants' personal beliefs about their identity and physical activity (e.g., I consider myself someone who does regular physical activity) (Wilson & Muon, 2008; Sparks & Shepard, 1992)
Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Decisional Intentions to be physically active (self-reported)
Time Frame: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)
Participants will be asked to fill in the blank: "I intend to engage in physical activity ______ times this next week" with the number of days they intend to be active. (Courneya, 1994)
Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jacob Gallagher

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Iowa State Fraternal Order of Eagles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202201021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data related to the primary outcome will be shared.

IPD Sharing Time Frame

The data will become available within 6 months after related publications.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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