Active KC: a Text Message Based Intervention for Physical Activity

• Sponsor: Children's Mercy Hospital Kansas City (Other)
• Overall Status: Completed
• CT.gov ID: NCT05110508
• Collaborator: (none)
• Enrollment: 210
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 29.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Physical Activity; Patient Engagement	Behavioral: Text Based Behavioral Intervention for Physical Activity	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Active KC: a Text Message Based Intervention for Physical Activity
• Actual Study Start Date: Sep 25, 2021
• Actual Primary Completion Date: Apr 30, 2022
• Actual Study Completion Date: Apr 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

1. Changes in Physical Activity Minutes Over Time [8 weeks]

   Participant physical activity will be measured by daily minutes of physical activity as collected by the Garmin monitor.

2. Changes in Physical Activity Steps Over Time [8 weeks]

   Participant physical activity will be measured by a daily step count as collected by the Garmin monitor.

Secondary Outcome Measures

1. Participant Engagement of Text Messages [8 weeks]

   Text message engagement as measured by number of texts responded to.

2. Views of Participants on Intervention Preferences via Participant Survey [Baseline, End of Study (8 weeks)]

   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.

3. Participant Engagement of the Garmin Monitor [8 weeks]

   Garmin activity monitor engagement as measured by number of wear days.

4. Views of Participants on intervention via Focus Groups [Week 4, Week 8]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Mercy	Kansas City	Missouri	United States	64108

Sponsors and Collaborators

• Children's Mercy Hospital Kansas City

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jordan Carlson, Study Principal Investigator, Children's Mercy Hospital Kansas City
• ClinicalTrials.gov Identifier: NCT05110508
• Other Study ID Numbers: STUDY00001939
• First Posted: Nov 8, 2021
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jordan Carlson, Study Principal Investigator, Children's Mercy Hospital Kansas City: text message; technology; Garmin; physical activity

Study Results

No Results Posted as of Jun 8, 2022