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Physical InactivityNCT05460637

Physical Activity Intervention Tailored for Rural Men

A study testing No BS just Fitness in people with Physical Inactivity and Sedentary Behavior, run by Jacob Gallagher at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years, men onlyHealthy volunteers can take part
What is being tested?
No BS just Fitness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Aug 2022to 20 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Field House

    Iowa City, Iowa, 52242

Other trials in United States

About this study

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

Being tested
No BS just Fitness
Keywords
physical activity, sedentary behavior, strength training, mHealth, rural, scalable
Medical subject headings
Sedentary Behavior, Asthenia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No BS just FitnessBehavioural

    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).

Study groups in NCT05460637
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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.
Receives: Behavioral: No BS just Fitness

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Measurements taken from Baseline (Week 0) to post-intervention (Week 11)

Secondary outcomes (8)

  1. 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)

    Measured: Measurements taken from Baseline (Week 0) to post-intervention (Week 11)

  2. 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).

    Measured: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)

  3. 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)

    Measured: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)

  4. 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)

    Measured: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)

  5. 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)

    Measured: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)

  6. 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))

    Measured: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)

  7. 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)

    Measured: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)

  8. 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)

    Measured: Measurements taken at Baseline (Week 0) and at post-intervention (Week 11)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2022
  2. Study start1 Aug 2022
  3. Primary completion20 Jan 2023
  4. Study completion20 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
This study uses a single-arm study with all participants receiving the intervention
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05460637
Sponsor's protocol ID
202201021
Status last verified
Feb 2023
First submitted
7 Jul 2022
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data related to the primary outcome will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing No BS just Fitness in people with Physical Inactivity and Sedentary Behavior, run by Jacob Gallagher at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Activity (average steps per day) (time frame: Measurements taken from Baseline (Week 0) to post-intervention (Week 11)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05460637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

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