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Sedentary Reduction Intervention for Type 2 Diabetes

N/A
Recruiting
Led By Chorong Park, PhD
Research Sponsored by Vanderbilt University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with type 2 diabetes
Self-report of sitting ≥ 8hr/day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will test a 12-week program to help diabetes patients reduce sedentary behavior and move more. The effects on physical activity, cardiometabolic markers and patient-centered outcomes will also be studied.

Who is the study for?
This trial is for adults over 18 with type 2 diabetes who sit for more than 8 hours a day and have an HbA1C level below 13. Participants must own a smartphone, be able to stand and walk, but not currently use an activity tracker or insulin, participate in other research, or have conditions that limit standing/walking.Check my eligibility
What is being tested?
The 'Sit Less' program is being tested to see if it helps people with type 2 diabetes reduce their sitting time using an activity monitor and mobile health technology. The study will last for 8 weeks and also look at how the program affects light physical activity levels and cardiometabolic health markers.See study design
What are the potential side effects?
Since this intervention involves lifestyle changes rather than medication, side effects may include muscle soreness or fatigue from increased physical activity. However, these are typically mild and decrease as participants get used to more movement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with type 2 diabetes.
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I sit for 8 hours or more each day.
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I can stand and walk on my own.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes of prolonged sedentary time
Changes of sit-to-stand transitions
Changes of total daily sedentary time
+2 more
Secondary outcome measures
Changes of 24-hour glucose levels assessed by continuous glucose monitors
Changes of confidence in reducing sedentary behavior measured by using 6 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.
Changes of habit strength for sedentary behavior assessed by using the Self-Report Habit Index.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment1 Intervention
The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor
703 Previous Clinical Trials
6,142,929 Total Patients Enrolled
Chorong Park, PhDPrincipal InvestigatorVanderbilt University
1 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Sit Less Program Clinical Trial Eligibility Overview. Trial Name: NCT05691452 — N/A
Type 2 Diabetes Research Study Groups: Intervention Group
Type 2 Diabetes Clinical Trial 2023: Sit Less Program Highlights & Side Effects. Trial Name: NCT05691452 — N/A
Sit Less Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05691452 — N/A
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05691452 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently seeking participants for this study?

"Per information on clinicaltrials.gov, this particular medical trial is not currently seeking applicants. The initial posting date was 25th of January 2023 and the most recent update to its status occured 10 days after that. This notwithstanding, there are still 1546 active trials looking for participants at present time."

Answered by AI

Could you elucidate the main purposes of this medical experiment?

"This trial, which will be tracked for 12 weeks, aims to measure how well participants adhere to the Fitbit device. Secondary objectives include gauging any changes in insulin levels measured with a dried blood spot card after fasting overnight (8+ hours) and analysing cholesterol and HbA1c via the same method."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Vanderbilt University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I just need serious help. I’ve tried almost everything. I just feel hopeless.
PatientReceived no prior treatments
~13 spots leftby Nov 2024