- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05110508
Active KC: a Text Message Based Intervention for Physical Activity
February 11, 2025 updated by: Jordan Carlson, Children's Mercy Hospital Kansas City
Active KC will involve delivering PA support tools to individuals interested in increasing their physical activity.
The tools involve provision of a Garmin wearable activity monitor and participant-tailored behavior change supports (e.g., goal setting and monitoring) delivered through text messaging and a corresponding study website.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
210
Phase
- 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
-
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Missouri
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Kansas City, Missouri, United States, 64108
- Children's Mercy
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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
Ages Eligible for Study
8 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Individual has a smart device with internet or data and app downloading and texting capability
- Can read or write in English
- At least 8 years old (there is no upper age limit)
- Willing to complete study measures, participate in intervention, and share data collected in Active KC with the main study
Exclusion Criteria:
- Does not meet the above inclusion criteria
- Non-adherent to study measurement (wearing the Garmin less than 4 days) during baseline period
- Averaging over 60 minutes per day of physical activity (children) or 30 minutes of physical activity per day (adults) during the baseline period as measured by the Garmin
- Participant has a disability that interferes with their ability to carry out daily activities
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Physical Activity Self-Regulation
Participants will receive multiple weekly text messages.
Texts will contain wear reminders, encouragements, congratulatory content, and behavior change messages based on the Garmin data.
Some text message content asks for a response from the participant to help tailor later messages for behavior change support.
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Text intervention messaging will be sent through an automated text messaging service programmed by the CM Informatics team, which has been approved by the institution.
Participants will be asked to wear Garmin physical activity monitor to provide physical activity information throughout the intervention.
The Garmin is worn like a wristwatch.
The device is small and non-intrusive.
The Garmin device is a consumer wearable that will automatically detect and track activity such as walking, running, and cycling.
The text messages incorporate information from the Garmin monitor to support physical activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Physical Activity Minutes Over Time
Time Frame: 8 weeks
|
Participant physical activity will be measured by daily minutes of physical activity as collected by the Garmin monitor.
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8 weeks
|
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Changes in Physical Activity Steps Over Time
Time Frame: 8 weeks
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Participant physical activity will be measured by a daily step count as collected by the Garmin monitor.
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8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Engagement of Text Messages
Time Frame: 8 weeks
|
Text message engagement as measured by number of texts responded to.
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8 weeks
|
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Views of Participants on Intervention Preferences via Participant Survey
Time Frame: Baseline, End of Study (8 weeks)
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Adults will complete a baseline and follow up adult survey and children will complete a baseline and follow up child survey with help from their caregiver when appropriate.
Participant surveys may be distributed via hardcopy, email, or text message.
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Baseline, End of Study (8 weeks)
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Participant Engagement of the Garmin Monitor
Time Frame: 8 weeks
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Garmin activity monitor engagement as measured by number of wear days.
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8 weeks
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Views of Participants on intervention via Focus Groups
Time Frame: Week 4, Week 8
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Up to 15 focus groups will be hosted throughout and after the intervention period.
A subsample of participants will be selected to take part in focus groups conducted after week 4 and week 8.
These focus groups will ask about participant experiences with the Garmin monitors and text messaging along with general perceptions of the intervention.
Focus groups will be hosted virtually using Teams or in person and will be recorded.
All participants will have the option to keep their cameras off during virtual focus groups.
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Week 4, Week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
September 25, 2021
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
September 9, 2021
First Submitted That Met QC Criteria
October 26, 2021
First Posted (Actual)
November 8, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 11, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00001939
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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