Active KC: a Text Message Based Intervention for Physical Activity

Physical Activity Clinical Trial

Official title:

Active KC: a Text Message Based Intervention for Physical Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05110508
• Other study ID #: STUDY00001939
• Status: Completed
• Phase: N/A
• Start date: September 25, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2023
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Engagement
• Physical Activity

Intervention

Behavioral:
• Text Based Behavioral Intervention for Physical Activity
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.

Locations

Country	Name	City	State
United States	Children's Mercy	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Physical Activity Minutes Over Time	Participant physical activity will be measured by daily minutes of physical activity as collected by the Garmin monitor.	8 weeks
Primary	Changes in Physical Activity Steps Over Time	Participant physical activity will be measured by a daily step count as collected by the Garmin monitor.	8 weeks
Secondary	Participant Engagement of Text Messages	Text message engagement as measured by number of texts responded to.	8 weeks
Secondary	Views of Participants on Intervention Preferences via Participant Survey	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.	Baseline, End of Study (8 weeks)
Secondary	Participant Engagement of the Garmin Monitor	Garmin activity monitor engagement as measured by number of wear days.	8 weeks
Secondary	Views of Participants on intervention via Focus Groups	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.	Week 4, Week 8