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Sit Less Group - mHealth intervention for Sedentary Lifestyle

N/A
Waitlist Available
Led By Chrong 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks post-intervention
Awards & highlights
No Placebo-Only Group

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 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.

Eligible Conditions
  • Sedentary Lifestyle
  • Physical Activity
  • Type 2 Diabetes

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of the Sedentary Behavior Reduction Intervention
Adherence to Sedentary Behavior Goals
Change in Total Sedentary Behavior Time
+3 more
Secondary study objectives
Change in 24-Hour Glycemic Control (GMI)
Change in Blood Pressure
Change in Body Mass Index (BMI)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sit Less Group - mHealth interventionExperimental Treatment1 Intervention
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.
Group II: Control Group - Standard CareActive Control1 Intervention
Participants in the control group will receive standard care, including educational materials from the American Heart Association's Healthy Living booklet and a Fitbit. They will not receive the smart water bottle or the tailored text messages aimed at reducing sedentary behavior. The Fitbit move alert setting will be disabled for the control group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sit Less Program
2023
N/A
~60

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Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor
710 Previous Clinical Trials
6,143,298 Total Patients Enrolled
Chrong Park, PhDPrincipal InvestigatorVanderbilt University
~3 spots leftby Nov 2025
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