NCT05691452

Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes

Technology-Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to develop and test an 8-week sedentary behavior reduction intervention ("Sit Less" program) for patients with type 2 diabetes. The program aims to reduce and break sitting times among this population using an objective activity monitor and mHealth. The investigators will test the program to help diabetes patients break up sitting time, reduce daily sitting time, and move more. The investigators will also study preliminary effects of the SB reduction intervention on light physical activity, cardiometabolic markers and patient-centered outcomes, and whether diabetes patients like the program and can follow it.

Detailed description

The investigators propose to develop and conduct a pilot study to test a wearable technology-based sedentary behavior reduction intervention in type 2 diabetes patients. The participants in the first cohort (n=15), 'Sit Less Version 1' will be randomized to either the control group or the sedentary behavior reduction intervention group. The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth. The study will have an iterative design process with multiple cohorts. After the first cohort completed the study, we will collect their feedback to modify the Sit Less program. With Sit Less Version 2, Cohort 2 (n=20) participants will participate in the intervention as a single group, without randomization. The Sit Less Version 2 will be 8 weeks long. Specifically, the study aims to: determine the feasibility and acceptability of the sedentary behavior reduction intervention in type 2 diabetes patients by evaluating reach, retention, satisfaction, and compliance with the intervention; evaluate the preliminary efficacy of the sedentary behavior reduction intervention on changes in sedentary time; and explore preliminary effects of the sedentary reduction intervention on physical activity, cardiometabolic markers and patient-centered outcomes.

Conditions

• Type 2 Diabetes
• Sedentary Behavior
• Physical Activity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-24
• Primary completion: 2024-01-05
• Completion: 2024-07-30
• First posted: 2023-01-20
• Last updated: 2025-03-19
• Results posted: 2025-03-19

Locations

1 site across 1 country: United States