Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457802
Status:
TERMINATED
Last Update Posted:
2024-06-14
First Post:
2024-05-28
Brief Title:
Sit Less Program for Patients With Type 2 Diabetes
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
A Multiple Technology-Based and Individually Tailored Sit Less Program for Patients With Type 2 Diabetes A Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI terminated the study due to unforeseen extenuating personal circumstances Despite attempts no other VUSN faculty had the expertise to take over The VUMC IRB approved the early termination of the study on 8202024
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 standingwalking 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 interventions 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None