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Completed

NCT Number: NCT05534256

Reducing Sedentary Time in Patients With Cardiovascular Disease

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.

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Key information

Conditions

Cardiovascular Diseases Behavior Heart Diseases Motor Activity Physical Activity Sedentary Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University

Nashville, Tennessee, 37240, United States

About this study

The investigators propose to develop and conduct a pilot 2-arm RCT to test a wearable technology-based sedentary behavior reduction intervention in cardiovascular disease patients. Participants 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.

Specifically, the study aims to: determine the feasibility and acceptability of the sedentary behavior reduction intervention in cardiovascular 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

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

    Time frame: Baseline to 12 weeks

    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.

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

    Time frame: Baseline to 12 weeks

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

  3. Changes of sedentary behavior assessed by 7 days of activPAL device monitoring

    Time frame: Baseline and 12 weeks

    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.

Secondary outcomes

  1. Changes of physical activity measured by 7 days of activPAL device monitoring

    Time frame: Baseline and 12 weeks

    Physical activity will be measured by 7 days of activPAL monitoring.

  2. Changes of cardiometabolic biomarkers measured by blood dried spot card

    Time frame: Baseline and 12 weeks

    Cardiometabolic markers including fasting cholesterols, insulin levels, HbA1c, fasting glucose, and hs-CRP will be measured by blood dried spot card. For blood samples, participants will fast overnight (at least 8 hours). The trained RA will conduct a finger prick and 8-9 drops of blood will be obtained on a dried blood spot card.

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

    Time frame: Baseline and 12 weeks

    Confidence in reducing sedentary behavior will be measured using 6 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.

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

    Time frame: Baseline and 12 weeks

    Habit strength for sedentary behavior will be assessed by 7 items from the Self-Report Sedentary Behavior Habit Index.

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

    Time frame: Baseline and 12 weeks

    24-hour glucose levels will be measured by the use of a continuous glucose monitor over a 7-day period. The 24-hour glucose control will be evaluated by mean 24-hour glucose levels and numbers of events and time in hypoglycaemia (glucose < 3.9 mmol/l), euglycaemia (glucose 3.9-7.8 mmol/l), hyperglycaemia (glucose > 7.8 mmol/l) and above target (glucose > 9 mmol/l).

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

Reducing Sedentary Time in Patients With Cardiovascular Disease: A Pilot Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 9, 2022
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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