Clinical trial NCT06457802: Sit Less Program for Patients With Type 2 Diabetes
Official title: A Multiple Technology-Based and Individually Tailored Sit Less Program for Patients With Type 2 Diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Sedentary Behavior
Sedentary Time
Physical Activity
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employs a parallel assignment interventional model, wherein participants are randomly allocated to one of two groups: the intervention group or the control group. The intervention group will receive a comprehensive sedentary behavior (SB) reduction program over 8 weeks, utilizing wearable technology, including Fitbit devices and smart water bottles, combined with personalized text message prompts. The control group will receive standard care, consisting of educational materials provided by the American Heart Association, without additional prompts or interventions. The primary goal is to compare the outcomes between these two groups to assess the feasibility, acceptability, and preliminary efficacy of the SB reduction intervention in reducing SB and improving cardiometabolic health and patient-centered outcomes in individuals with type 2 diabetes.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Total Sedentary Behavior Time
timeFrame: Baseline and 8 weeks post-intervention
measure: Acceptability of the Sedentary Behavior Reduction Intervention
timeFrame: 8 weeks post-intervention
measure: Usability of the Sedentary Behavior Reduction Intervention
timeFrame: 8 weeks post-intervention
measure: Compliance With the Sedentary Behavior Reduction Intervention - Fitbit Usage
timeFrame: 8 weeks post-intervention
measure: Adherence to Sedentary Behavior Goals
timeFrame: 8 weeks post-intervention
measure: Response Rates to Tailored Text Messages
timeFrame: 8 weeks post-intervention
Secondary outcomes:
measure: Change in Number of Prolonged Sedentary Bouts
timeFrame: Baseline and 8 weeks post-intervention
measure: Change in Light Physical Activity
timeFrame: Baseline and 8 weeks post-intervention
measure: Change in 24-Hour Glycemic Control (GMI)
timeFrame: Baseline and 8 weeks post-intervention
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and 8 weeks post-intervention
measure: Change in Waist Circumference
timeFrame: Baseline and 8 weeks post-intervention
measure: Change in Blood Pressure
timeFrame: Baseline and 8 weeks post-intervention
measure: Change in Confidence in Reducing Sedentary Behavior
timeFrame: Baseline and 8 weeks post-intervention
measure: Change in Habit Strength for Sedentary Behavior
timeFrame: Baseline and 8 weeks post-intervention
measure: Change in Quality of Life
timeFrame: Baseline and 8 weeks post-intervention
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Shelagh Mulvaney, PhD
role: PRINCIPAL_INVESTIGATOR
References: