Sit Less Program for Patients With Type 2 Diabetes
NCT Number: NCT06457802
Status: TERMINATED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes|Sedentary Behavior|Sedentary Time|Physical Activity
Interventions: BEHAVIORAL: Sit Less Program
Sponsor: Vanderbilt University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06-12
Completion Date: 2024-08-20
Locations: Vanderbilt University, Nashville, Tennessee, 37240, United States

Summary:
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.

Primary Outcome Measures: Change in Total Sedentary Behavior Time, 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., Baseline and 8 weeks post-intervention|Acceptability of the Sedentary Behavior Reduction 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., 8 weeks post-intervention|Usability of the Sedentary Behavior Reduction 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., 8 weeks post-intervention|Compliance with the Sedentary Behavior Reduction Intervention - Fitbit Usage, 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., 8 weeks post-intervention|Adherence to Sedentary Behavior Goals, Adherence will be evaluated by tracking the percentage of set sedentary behavior reduction goals met by participants., 8 weeks post-intervention|Response Rates to Tailored Text Messages, Compliance will be evaluated by tracking the response rates (percentage) to the tailored text messages sent as part of the intervention., 8 weeks post-intervention
Secondary Outcome Measures: Change in Number of Prolonged Sedentary Bouts, This measure will assess the change in the number of prolonged sedentary bouts, defined as periods of uninterrupted sitting or lying down lasting 30 minutes or more. Data will be collected using the activPAL device worn by participants for 7 days at both baseline and post-intervention., Baseline and 8 weeks post-intervention|Change in Light Physical Activity, This measure will evaluate changes in light physical activity, including total standing and stepping times. Participants will wear the activPAL device for 7 days at both baseline and post-intervention to capture these activity levels., Baseline and 8 weeks post-intervention|Change in 24-Hour Glycemic Control (GMI), 24-hour glucose levels will be measured by continuous glucose monitoring over a 7-day period. The 24-hour glucose control will be evaluated using the Glucose Management Indicator (GMI), which provides an estimated average glucose (eAG) based on the mean 24-hour glucose levels. The GMI will be calculated from the mean glucose values and reported as a single aggregated value. Additionally, the numbers of events and time in hypoglycemia (glucose \< 3.9 mmol/L), euglycemia (glucose 3.9-7.8 mmol/L), hyperglycemia (glucose \> 7.8 mmol/L), and above target (glucose \> 9 mmol/L) will be monitored to provide context to the GMI value, but these will not be separately reported as primary outcome measures.

Unit of Measure: GMI (Glucose Management Indicator, as a percentage), Baseline and 8 weeks post-intervention|Change in Body Mass Index (BMI), This measure will evaluate changes in BMI, calculated using participants' height and weight measurements taken at baseline and post-intervention., Baseline and 8 weeks post-intervention|Change in Waist Circumference, This measure will assess changes in waist circumference, measured at the narrowest point between the rib cage and the iliac crest using a flexible tape measure., Baseline and 8 weeks post-intervention|Change in Blood Pressure, This measure will evaluate changes in systolic and diastolic blood pressure, measured using an automated and validated blood pressure monitor at baseline and post-intervention., Baseline and 8 weeks post-intervention|Change in Confidence in Reducing Sedentary Behavior, This measure will assess changes in participants' confidence in their ability to reduce sedentary behavior, evaluated using a validated self-efficacy questionnaire for physical activity and sedentary behavior. Confidence in reducing SB and increasing physical activity will be measured using 12 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior (Cronbach's alpha = 0.79). Each item is rated on a 5-point Likert scale ranging from 1 (not at all confident) to 5 (extremely confident). The total score ranges from 12 to 60, with higher scores indicating greater confidence in reducing sedentary behavior and increasing physical activity., Baseline and 8 weeks post-intervention|Change in Habit Strength for Sedentary Behavior, This measure will evaluate changes in habit strength for sedentary behavior, assessed using the Self-Report Habit Index adapted for sedentary breaks (standing/walking). Habit strength for SB will be assessed by using a validated measure, Self-Report Habit Index (Cronbach's alpha = 0.91). This 7- item index was adapted to sedentary breaks (standing/walking) to assess the degree to which sedentary breaks become habitual. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 7 to 35, with higher scores indicating stronger habit strength for taking sedentary breaks., Baseline and 8 weeks post-intervention|Change in Quality of Life, Quality of life will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Global Health, a 10-item measure developed by the NIH as an indicator for Healthy People. Each item is rated on a 5-point Likert scale, and the total score is calculated to range from 10 to 50. Higher scores indicate better quality of life., Baseline and 8 weeks post-intervention