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Sit Less Program for Heart Disease

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 weeks

Awards & highlights

Study Summary

This trial will develop and test a 12-week program to help reduce sedentary behavior in heart disease patients using an activity monitor and mHealth technology. The goal is to improve heart disease risk factors and patient engagement.

Who is the study for?

This trial is for adults over 18 with cardiovascular disease who sit for 8+ hours a day and can stand and walk. They must own a smartphone but not be in cardiac rehab, pregnant, using an activity tracker, or have conditions that limit standing/walking or require restricted water intake.Check my eligibility

What is being tested?

The 'Sit Less' program aims to reduce sitting time among patients with heart disease through a 12-week intervention using an activity monitor and mobile health technology. The study will assess if this helps improve risk factors associated with heart disease.See study design

What are the potential side effects?

Since the intervention involves lifestyle changes rather than medication, side effects may include muscle soreness or fatigue due to increased physical activity. However, specific side effects are not detailed as it's not drug-related.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 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

Medical Devices

Level of compliance with the intervention assessed by number of days the Fitbit device was worn

Level of satisfaction with the intervention assessed by the System Usability Scale and exit-interview

Secondary outcome measures

Changes of 24-hour glucose levels assessed by continuous glucose monitors

Changes of cardiometabolic biomarkers measured by blood dried spot card

Changes of confidence in reducing sedentary behavior measured by using 6 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

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.

Group II: Control GroupActive Control1 Intervention

The control group will receive usual medical care and American Heart Association's Healthy Living booklet

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor

703 Previous Clinical Trials

6,143,277 Total Patients Enrolled

Chorong Park, PhDPrincipal InvestigatorVanderbilt University

1 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

Sit Less Program Clinical Trial Eligibility Overview. Trial Name: NCT05534256 — N/A

Cardiovascular Disease Clinical Trial 2023: Sit Less Program Highlights & Side Effects. Trial Name: NCT05534256 — N/A

Sit Less Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05534256 — N/A

Cardiovascular Disease Research Study Groups: Intervention Group, Control Group

Frequently Asked Questions

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

What fundamental aims are being sought in this trial?

"The primary endpoint of this medical trial, which will be evaluated at Baseline and 12 weeks, is patient satisfaction with the intervention as surveyed by System Usability Scale scores and an exit-interview. Secondary endpoints include changes in sedentary behavior habit strength (as measured via Self-Report Habit Index), physical activity levels monitored over 7 days using activPAL devices, and self-efficacy for reducing sedentary behaviour assessed through 6 questions from the relevant survey."

Answered by AI

How many participants are participating in this clinical research project?

"Affirmative. Clinicaltrials.gov is hosting information that attests to this clinical trial's active recruitment of 70 participants at 1 site, which was first posted on September 13th 2022 and last updated on the 23rd."

Answered by AI

Has recruitment opened for participants of this experiment?

"This trial is still open to applicants, with the original listing debuting on September 13th 2022 and having been recently updated on September 23rd."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Sedentary Time in Patients With Cardiovascular Disease

Chorong Park 2022. "Reducing Sedentary Time in Patients With Cardiovascular Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05534256.