NCT05460637

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

July 7, 2022

Last Update Submit

February 17, 2023

Conditions

Keywords

physical activitysedentary behaviorstrength trainingmHealthruralscalable

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

EXPERIMENTAL

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

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).

Intervention Group

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsWe are asking participants to select what gender best describes them. Since our program is tailored specifically to the needs of men, we are recruiting only participants who identify as males.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Field House

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorAstheniaMotor Activity

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This study uses a single-arm study with all participants receiving the intervention
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

All data related to the primary outcome will be shared.

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.

Locations