Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05691452
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2023-01-05
Brief Title:
Technology Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Technology-Based Sedentary Reduction Intervention in Patients With Type 2 Diabetes A Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 n15 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 Cohort 2 n10 and cohort 3 n10 participants will participate in the intervention
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
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
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