Physical Activity Intervention Tailored for Rural Men

Physical Inactivity Clinical Trial

Official title:

Physical Activity Intervention Tailored for Rural Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05460637
• Other study ID #: 202201021
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: January 20, 2023

Study information

• Verified date: February 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Inactivity
• Sedentary Behavior
• Weak; Muscle

Intervention

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).

Locations

Country	Name	City	State
United States	Field House	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Jacob Gallagher	Iowa State Fraternal Order of Eagles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)