- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06700525
StandUPTV Habits: Feasibility Trial for Maintaining Reductions in Sedentary Screen Time (SUTV Habits)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85281
- Recruiting
- Arizona State University
-
Contact:
- Chad Stecher
- Phone Number: 602-496-0957
- Email: Chad.Stecher@asu.edu
-
-
California
-
San Luis Obispo, California, United States, 93407
- Recruiting
- California Polytechnic University San Luis Obispo
-
Contact:
- Sarah Keadle
- Phone Number: 805-756-1785
- Email: skeadle@calpoly.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Insufficiently active as defined by not meeting current US National Guidelines for Physical Activity of 150 minutes of MVPA/week (Measured by the Stanford
- Leisure-Time Activity Categorical Item)
- > 3 hours of SST per day
- Use Android (8.0+) smartphone (8.0+ represents 95% of Android device coverage per https://apilevels.com/)
- Have regular broadband internet in their home or an unlimited data plan
- Able to read/understand English (>5th grade literacy)
- Willing to download StandUPTV Habits
- Willing to wear activPAL and CGM device during study assessment periods
- Willing to have data shared in de-identified form in Dexcom Clarity platform
- Willing to be randomized to either study condition
- Not traveling overnight or longer in the next 4 months
Exclusion Criteria:
- Planned relocation
- Current smoker
- Have a major illness (e.g., heart disease, cancer, renal disease) for which MVPA is contraindicated
- Diagnosed with diabetes or gestational diabetes in the past
- Currently using a CGM
- Pregnant
- Occupation that requires substantial use of personal device for media-related activities (e.g., social media)
- Drug abuse
- Serious psychological disorder
- Not willing to use Fitbit or smart plugs for calculation of sedentary screen time for functionality of StandUPTV app
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: StandUPTV only
The StandUPTV application is used to monitor and reduce sedentary screen time (SST).
The StandUPTV app has three components: LOCKOUT: Electronic lockout turns off screens when a predetermined limit is reached (50% of baseline value of weekly sedentary screen time).
The app also includes planning tools and personalized strategies to limit SST.
TEXT: Push notification prompts provide reminders, coaching, and personalized feedback (up to 2 per day).
EARN: Opportunities to earn SST by engaging in MVPA, measured in 10-minute bouts.
|
Action Plans Addition to the StandUPTV platform: The StandUPTV mHealth platform will be used to assess SST and deliver behavior change components. Participants will receive a technology kit including a Fitbit Charge 4+ and Wi-Fi-enabled smart plugs. The Fitbit and smart plugs will need to be used for the entire duration of the study participation. Participants will also be assisted with establishing an action plan for a non-sedentary break from evening sedentary screen time, which will be trigger by a StandUPTV alert delivered after performing 30 minutes of evening sedentary screen time. |
|
Experimental: StandUPTV + Action Plans
Combining the StandUPTV application with personalized action plans to enhance the maintenance of reduced eSST.
At baseline, participants will receive Action Planning Education, action planning worksheet, and weekly personalized text messages reinforcing the action plan.
Participant will then receive a daily StandUPTV alert after performing 30 minutes of eSST, and they have 60 minutes after the alert to engage in their active chosen non-sedentary behavior.
Financial Incentives: Participants can earn up to $30 per month during the 4-month intervention by starting 10 minutes of their non-sedentary replacement behavior within 60 minutes of the alert.
Participants start with $30 in their account and lose $2 for each day they do not perform the behavior.
Notifications will be sent via SMS and the StandUPTV app.
|
Action Plans Addition to the StandUPTV platform: The StandUPTV mHealth platform will be used to assess SST and deliver behavior change components. Participants will receive a technology kit including a Fitbit Charge 4+ and Wi-Fi-enabled smart plugs. The Fitbit and smart plugs will need to be used for the entire duration of the study participation. Participants will also be assisted with establishing an action plan for a non-sedentary break from evening sedentary screen time, which will be trigger by a StandUPTV alert delivered after performing 30 minutes of evening sedentary screen time.
The StandUPTV application is used to monitor and reduce sedentary screen time (SST).
The StandUPTV app has three components: LOCKOUT: Electronic lockout turns off screens when a predetermined limit is reached (50% of baseline value of weekly sedentary screen time).
The app also includes planning tools and personalized strategies to limit SST.
TEXT: Push notification prompts provide reminders, coaching, and personalized feedback (up to 2 per day).
EARN: Opportunities to earn SST by engaging in MVPA, measured in 10-minute bouts.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Sedentary Screen Time
Time Frame: Baseline, 4 months, 12 months
|
Minutes per week as measured by Stand UPTV app and activPAL
|
Baseline, 4 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in moderate to vigorous physical activity
Time Frame: Baseline, 4 months, 12 months
|
Minutes per week as measured by activPAL
|
Baseline, 4 months, 12 months
|
|
Changes in Sleep Quality
Time Frame: Baseline, 4 months, 12 months
|
Measured in minutes of deep sleep
|
Baseline, 4 months, 12 months
|
|
Changes in Glucose Metabolism
Time Frame: Baseline, 4 months, 12 months
|
Measured HbA1c levels
|
Baseline, 4 months, 12 months
|
|
HbA1c Level
Time Frame: Baseline, 4 months, 12 months
|
Participants continuous glucose monitoring data will be used to estimates HbA1c levels
|
Baseline, 4 months, 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00020613
- 1R01DK135488-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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