NCT06457802Terminated
Sit Less Program for Patients With Type 2 Diabetes
A Multiple Technology-Based and Individually Tailored Sit Less Program for Patients With Type 2 Diabetes: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Reason given: The PI terminated the study due to unforeseen extenuating personal circumstances. The VUMC IRB approved the early termination of the study on 8/20/2024. The last day the participants received the intervention was 08/20/2024.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 28 May 2024
- Start date
- 12 Jun 2024
- Primary completion date
- 20 Aug 2024
- Lead sponsor
- Vanderbilt University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06457802
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- currently using an activity tracker
Other illness
- 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.
Lab values
- random blood glucose > 300 mg/dL.
Other
- currently participating in exercise or other research programs.
- non-English speaking.
- participation in Sit Less Program V1 (IRB #221566).
- currently pregnant.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.