A Multiple Technology-Based and Individually Tailored Sit Less Program for Patients With Type 2 Diabetes: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Type 2 Diabetes
- 发起方
- Vanderbilt University
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in Total Sedentary Behavior Time
- 状态
- 终止
- 最后更新
- 去年
概览
简要总结
This randomized controlled trial aims to evaluate an 8-week intervention designed to reduce sedentary behavior (SB) in patients with type 2 diabetes (T2D) using wearable technology. The intervention involves the use of Fitbit devices to prompt standing/walking breaks, a smart water bottle to encourage hydration-related movement, and tailored text messages for behavior reinforcement. Participants will be assessed at baseline and post-intervention for changes in SB, light physical activity, cardiometabolic markers, and patient-centered outcomes. The study seeks to determine the intervention's acceptability and preliminary efficacy in reducing SB and improving health outcomes in T2D patients.
详细描述
The investigators propose to develop and conduct a pilot randomized controlled trial to test a wearable technology-based sedentary behavior (SB) reduction intervention in type 2 diabetes (T2D) patients. The study will recruit 80 participants who will be randomized to either the control group or the intervention group. The 8-week intervention aims to reduce daily SB by at least 120 minutes through the use of Fitbit devices, a smart water bottle, and tailored text messages. Participants will set personalized SB reduction goals and receive prompts to stand or walk, along with hydration reminders from the smart water bottle to encourage movement. Specifically, the study aims to: determine the acceptability of the SB reduction intervention in T2D patients by evaluating satisfaction and compliance; evaluate the preliminary efficacy of the intervention on reducing total SB time and numbers of prolonged SB bouts; and explore preliminary effects on light physical activity, cardiometabolic markers (24-hour glycemic control, BMI, waist circumference, blood pressure), and patient-centered outcomes (confidence in reducing SB, habit strength for SB, and quality of life). Outcomes will be measured at baseline and post-intervention using biometric assessments, questionnaires, and continuous glucose monitoring. The study seeks to provide insights into the feasibility and potential health benefits of a technology-driven SB reduction program for T2D patients.
研究者
Shelagh Mulvaney
Principal Investigator
Vanderbilt University
入排标准
入选标准
- •ages 18 and above
- •diagnosed with type 2 diabetes
- •self-reported HbA1C\<13
- •self-report of sitting ≥ 8hr/day
- •ability to stand and walk
- •ownership of a smartphone.
排除标准
- •currently using an activity tracker
- •currently participating in exercise or other research programs.
- •random blood glucose \> 300 mg/dL.
- •non-English speaking.
- •patients classified as unstable (e.g., heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake.
- •any conditions that prevent standing or walking due to physical or cognitive limitations, such as cognitive impairment, severe pain, problems with lower limbs, or a history of surgeries that limit movement.
- •participation in Sit Less Program V1 (IRB #221566).
- •currently pregnant.
结局指标
主要结局
Change in Total Sedentary Behavior Time
时间窗: Baseline and 8 weeks post-intervention
The primary outcome measure will assess the change in total sedentary behavior (SB) time from baseline to post-intervention. Sedentary behavior will be objectively measured using the activPAL device, which participants will wear on their thigh for 7 days at both baseline and post-intervention. The activPAL device will record the amount of time participants spend sitting or lying down during waking hours each day.
Acceptability of the Sedentary Behavior Reduction Intervention
时间窗: 8 weeks post-intervention
Satisfaction will be assessed using a 23-item questionnaire. This questionnaire includes items on the perceived helpfulness, ease of use, and overall experience with the wearable devices, text messages, and goal-setting sessions. The questionnaire uses a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater satisfaction with the intervention.
Usability of the Sedentary Behavior Reduction Intervention
时间窗: 8 weeks post-intervention
Usability will be assessed using a 10-item System Usability Scale. The System Usability Scale provides a global measure of usability and uses a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). It has a minimum score of 0 and a maximum score of 100, where higher scores indicate better usability.
Adherence to Sedentary Behavior Goals
时间窗: 8 weeks post-intervention
Adherence will be evaluated by tracking the percentage of set sedentary behavior reduction goals met by participants.
Response Rates to Tailored Text Messages
时间窗: 8 weeks post-intervention
Compliance will be evaluated by tracking the response rates (percentage) to the tailored text messages sent as part of the intervention.
Compliance With the Sedentary Behavior Reduction Intervention - Fitbit Usage
时间窗: 8 weeks post-intervention
Compliance with the intervention will be evaluated by tracking the usage data from the Fitbit devices, specifically the number of days the device was worn for at least 10 hours per day.
次要结局
- Change in Light Physical Activity(Baseline and 8 weeks post-intervention)
- Change in Waist Circumference(Baseline and 8 weeks post-intervention)
- Change in Number of Prolonged Sedentary Bouts(Baseline and 8 weeks post-intervention)
- Change in Body Mass Index (BMI)(Baseline and 8 weeks post-intervention)
- Change in Confidence in Reducing Sedentary Behavior(Baseline and 8 weeks post-intervention)
- Change in Blood Pressure(Baseline and 8 weeks post-intervention)
- Change in Habit Strength for Sedentary Behavior(Baseline and 8 weeks post-intervention)
- Change in 24-Hour Glycemic Control (GMI)(Baseline and 8 weeks post-intervention)
- Change in Quality of Life(Baseline and 8 weeks post-intervention)