Sit Less Program for Patients With Type 2 Diabetes

Vanderbilt University

Status: Terminated

Conditions: Physical Activity; Type 2 Diabetes; Sedentary Time; Sedentary Behavior

Treatments: Behavioral: Sit Less Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06457802

240549

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Sit Less Group - mHealth intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Sit Less Program

Control Group - Standard Care

No Intervention group

Description:

Participants in the control group will receive standard care, including educational materials from the American Heart Association's Healthy Living booklet and a Fitbit. They will not receive the smart water bottle or the tailored text messages aimed at reducing sedentary behavior. The Fitbit move alert setting will be disabled for the control group.