Reducing Sedentary Time in Patients With Cardiovascular Disease

NCT05534256 | Completed

• 1 other identifier: 220416
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop and test a 12-week sedentary behavior reduction intervention ("Sit Less" program) for patients with cardiovascular disease. 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 cardiovascular disease patients break up sitting time, reduce daily sitting time, and move more. The investigators will also study whether the program leads to improvements in heart disease risk factors, and whether cardiovascular disease patients like the program and can follow it.

Conditions

Cardiovascular Diseases; Heart Diseases; Sedentary Behavior; Physical Activity

Keywords

Sedentary behavior; Cardiovascular disease

Outcome Measures

Primary Outcomes (3)

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

  Level of satisfaction with the intervention will be assessed by using the 10-item of system usability scale. An exit interview will be conducted by the intervention among subsamples of the intervention group (n =20) during the post-intervention visit. The interview will assess the acceptability of and satisfaction with the intervention, barriers and facilitators to sedentary behavior reduction, and any alternate strategies tried by participants during the study.

  Baseline to 12 weeks

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

  The compliance with the intervention will be assessed by number of days the Fitbit device was worn per week.

  Baseline to 12 weeks

• Changes of sedentary behavior assessed by 7 days of activPAL device monitoring

  Sedentary behavior will be assessed by three parameters including total daily sedentary time, prolonged sedentary time (time spent sitting \>30mins), and numbers of sit-to-stand transition. These three sedentary behavior parameters will be measured by 7 days of activPAL 3 device monitoring.

  Baseline and 12 weeks

Secondary Outcomes (5)

• Changes of physical activity measured by 7 days of activPAL device monitoring

  Baseline and 12 weeks

• Changes of cardiometabolic biomarkers measured by blood dried spot card

  Baseline and 12 weeks

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

  Baseline and 12 weeks

• Changes of habit strength for sedentary behavior assessed by using the Self-Report Habit Index.

  Baseline and 12 weeks

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

  Baseline and 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.

Behavioral: Sit Less Program

Control Group

NO INTERVENTION

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

Interventions

Sit Less Program BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 and above
• Have at least one of the following conditions including history of heart attack or peripheral artery disease or a stent placed in heart or leg
• Self-report of sitting ≥ 8 hr/day
• Ability to stand and walk
• Ownership of a smartphone

You may not qualify if:

• Currently using an activity tracker
• Currently participating in exercise of cardiac rehabilitation programs
• Non-English speaking
• Patients who are classified as unstable (e.g. heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake, or any other conditions contradictory to standing or walking and
• Currently pregnant

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Chorong Park, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor and statistician will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 9, 2022
• Study Start: September 13, 2022
• Primary Completion: July 19, 2023
• Study Completion: July 30, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)