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Cardiovascular DiseasesNCT05534256

Reducing Sedentary Time in Patients With Cardiovascular Disease

A study testing Sit Less Program in people with Cardiovascular Diseases and Heart Diseases, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Sit Less Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
13 Sep 2022to 30 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University

    Nashville, Tennessee, 37240

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Sit Less Program
Keywords
Sedentary behavior, Cardiovascular disease
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sit Less ProgramBehavioural

    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

Study groups in NCT05534256
Study groupRoleWhat they receive
Intervention GroupExperimentalThe intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.
Receives: Behavioral: Sit Less Program
Control GroupNo interventionThe control group will receive usual medical care and American Heart Association's Healthy Living booklet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 12 weeks

  2. 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.

    Measured: Baseline to 12 weeks

  3. 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.

    Measured: Baseline and 12 weeks

Secondary outcomes (5)

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

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

    Measured: Baseline and 12 weeks

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

    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.

    Measured: Baseline and 12 weeks

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

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

    Measured: Baseline and 12 weeks

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

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

    Measured: Baseline and 12 weeks

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

    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).

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2022
  2. Study start13 Sep 2022
  3. Primary completion19 Jul 2023
  4. Study completion30 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05534256
Sponsor's protocol ID
220416
Status last verified
Jul 2024
First submitted
24 Aug 2022
Last updated
31 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The investigator does not have plans to share data at this time. In the future, reasonable requests for de-identified data from other scientists will be considered. Such data will be shared with approval by the Study PI and other investigators, as appropriate.

Publications

  • Park C, Dietrich MS, Larsen B, Mayberry LS, Doyle A, Ahn S, Jean J, Maquiling K, Mogos MF, Muchira JM, Mulvaney S. Feasibility and Preliminary Efficacy of a "Sit Less" Program Leveraging Fitbit Tracking and Tailored Text Messages in Cardiometabolic Disease: Findings From 2 Parallel Randomized Controlled Trials in Coronary Artery Disease and Type 2 Diabetes. JMIR Mhealth Uhealth. 2026 Aug 25;14:e56497. doi: 10.2196/56497.

    PubMed 42641078

  • Park C, Larsen B, Mogos M, Muchira J, Dietrich M, LaNoue M, Jean J, Norfleet J, Doyle A, Ahn S, Mulvaney S. A multiple technology-based and individually-tailored Sit Less program for people with cardiovascular disease: A randomized controlled trial study protocol. PLoS One. 2024 May 9;19(5):e0302582. doi: 10.1371/journal.pone.0302582. eCollection 2024.

    PubMed 38722831

Questions about this trial

What is this clinical trial studying?

A study testing Sit Less Program in people with Cardiovascular Diseases and Heart Diseases, run by Vanderbilt University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of satisfaction with the intervention assessed by the System Usability Scale and exit-interview (time frame: Baseline to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05534256, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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