Glucose Metabolism, HbA1c Level, Physical Activity, Screen Time, Sedentary Behaviors, Sleep Quality
Conditions
Keywords
sedentary behavior, action planning, evening sedentary screen time, mHealth
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.
Interventions
BEHAVIORALNon-Sedentary Behavior Habit Formation
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.
BEHAVIORALSedentary Screen Time Reduction Smartphone App
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.
Sponsors
Arizona State University
California Polytechnic State University-San Luis Obispo
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor will not have access to study arm assignment and participants will be encouraged not to divulge their study arm assignment during assessments.
Eligibility
Sex/Gender
ALL
Age
23 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Sedentary Screen Time | Baseline, 4 months, 12 months | Minutes per week as measured by Stand UPTV app and activPAL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in moderate to vigorous physical activity | Baseline, 4 months, 12 months | Minutes per week as measured by activPAL |
| Changes in Sleep Quality | Baseline, 4 months, 12 months | Measured in minutes of deep sleep |
| Changes in Glucose Metabolism | Baseline, 4 months, 12 months | Measured HbA1c levels |
| HbA1c Level | Baseline, 4 months, 12 months | Participants continuous glucose monitoring data will be used to estimates HbA1c levels |
Countries
United States
Outcome results
None listed