Clinical trial NCT06700525: StandUPTV Habits: Feasibility Trial for Maintaining Reductions in Sedentary Screen Time
Official title: StandUPTV Habits: Feasibility Trial for Maintaining Reductions in Sedentary Screen Time
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sedentary Behaviors
Screen Time
Physical Activity
Glucose Metabolism
Sleep Quality
HbA1c Level
Keywords: sedentary behavior
action planning
evening sedentary screen time
mHealth
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: California Polytechnic State University-San Luis Obispo
name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-11-22
Enrollment: 48
Sex: ALL
Minimum age (years): 23
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our goal in this study is to further refine StandUPTV, an application designed to reduce SST in adults in our first study (ASU IRB # STUDY00012109), for the StandUPTV Habits program. This program aims to establish a non-sedentary habit triggered by an alert from the StandUPTV application after participants engage in approximately 30 minutes of SST in the evening.

Detailed description: This mobile health (mHealth) pilot study aims to develop and test an intervention designed to maintain reductions in evening sedentary screen time (eSST) over a 12-month period. The study will target a nationally recruited sample of adults at risk for type 2 diabetes and will employ a novel habit formation strategy to address individual barriers to sustained behavior change. As a Phase II pilot study within the ORBIT Model framework, this research seeks to provide critical insights into the relationship between maintained reductions in eSST and metabolic health. The intervention combines theory- and evidence-based approaches, leveraging commercially available screen time monitoring tools to scale the StandUPTV application. This pilot study will lay the groundwork for a subsequent Phase III fully-powered randomized clinical trial, aiming to evaluate the impact of sustained eSST reduction on diabetes and cardiovascular disease risk in a national sample.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Sedentary Screen Time
timeFrame: Baseline, 4 months, 12 months
Secondary outcomes:
measure: Changes in moderate to vigorous physical activity
timeFrame: Baseline, 4 months, 12 months
measure: Changes in Sleep Quality
timeFrame: Baseline, 4 months, 12 months
measure: Changes in Glucose Metabolism
timeFrame: Baseline, 4 months, 12 months
measure: HbA1c Level
timeFrame: Baseline, 4 months, 12 months
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
city: San Luis Obispo
country: United States
facility: California Polytechnic University San Luis Obispo
state: California
Study officials:
References: