Sit Less Program for Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

A Multiple Technology-Based and Individually Tailored Sit Less Program for Patients With Type 2 Diabetes: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457802
• Other study ID #: 240549
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: April 29, 2025

Study information

• Verified date: June 2024
• Source: Vanderbilt University
• Contact: Abigail M Doyle, BS
• Phone: 6153436075
• Email: abigail.m.doyle[@]vanderbilt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 29, 2025
• Est. primary completion date: April 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Physical Activity
• Sedentary Behavior
• Sedentary Time
• Type 2 Diabetes

Intervention

Behavioral:
• Sit Less Program
The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth. Outcomes will be measured at baseline and post-intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acceptability of the Sedentary Behavior Reduction Intervention	Satisfaction will be assessed using a 23-item questionnaire developed by Lyons, Swartz, Lewis, Martinez, and Jennings (2017) and Burner et al. (2014). 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
Primary	Usability of the Sedentary Behavior Reduction Intervention	Usability will be assessed using the 10-item System Usability Scale (SUS). The SUS provides a global measure of usability and uses a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The SUS has a minimum score of 0 and a maximum score of 100, where higher scores indicate better usability.	8 weeks post-intervention
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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