StandUPTV Habits: Feasibility Trial for Maintaining Reductions in Sedentary Screen Time
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Changes in Sedentary Screen Time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will not have access to study arm assignment and participants will be encouraged not to divulge their study arm assignment during assessments.
入排标准
- 年龄范围
- 23 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Non-Sedentary Behavior Habit Formation (Behavioral)
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.
干预措施: Non-Sedentary Behavior Habit Formation (Behavioral)
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.
干预措施: Sedentary Screen Time Reduction Smartphone App (Behavioral)
结局指标
主要结局
Changes in Sedentary Screen Time
时间窗: Baseline, 4 months, 12 months
Minutes per week as measured by Stand UPTV app and activPAL
次要结局
- Changes in moderate to vigorous physical activity(Baseline, 4 months, 12 months)
- Changes in Sleep Quality(Baseline, 4 months, 12 months)
- Changes in Glucose Metabolism(Baseline, 4 months, 12 months)
- HbA1c Level(Baseline, 4 months, 12 months)
研究者
Chad Stecher@asu.edu
Assistant Professor
Arizona State University