NCT05110508

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

September 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

September 9, 2021

Last Update Submit

February 11, 2025

Conditions

Physical ActivityPatient Engagement

Keywords

text messagetechnologyGarminphysical activity

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Participant Engagement of Text Messages

    8 weeks

  • Views of Participants on Intervention Preferences via Participant Survey

    Baseline, End of Study (8 weeks)

  • Participant Engagement of the Garmin Monitor

    8 weeks

  • Views of Participants on intervention via Focus Groups

    Week 4, Week 8

Study Arms (1)

Physical Activity Self-Regulation

EXPERIMENTAL

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

Interventions

Text Based Behavioral Intervention for Physical ActivityBEHAVIORAL

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.

Physical Activity Self-Regulation

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Motor ActivityPatient Participation

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

September 9, 2021

First Posted

November 8, 2021

Study Start

September 25, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

US(1)