Physical Activity Intervention Tailored for Rural Men

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: Completed
• Conditions: Sedentary Behavior; Physical Inactivity; Weak; Muscle
• Intervention / Treatment: Behavioral: No BS just Fitness

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscular Strength	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)	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)	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)	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)	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)	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)	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)	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

• Sponsor: Jacob Gallagher
• Collaborators: Iowa State Fraternal Order of Eagles

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; strength training; mHealth; sedentary behavior; rural; scalable
• Other Study ID 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