Reducing Sedentary Time in Patients With Cardiovascular Disease
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Sedentary Behavior
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sit Less Program
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Sedentary behavior, Cardiovascular disease
Eligibility Criteria
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
Sites / Locations
- Vanderbilt UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.
The control group will receive usual medical care and American Heart Association's Healthy Living booklet
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Changes of physical activity measured by 7 days of activPAL device monitoring
Physical activity will be measured by 7 days of activPAL monitoring.
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.
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05534256
Brief Title
Reducing Sedentary Time in Patients With Cardiovascular Disease
Official Title
Reducing Sedentary Time in Patients With Cardiovascular Disease: A Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
September 12, 2024 (Anticipated)
Study Completion Date
September 12, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Sedentary Behavior, Physical Activity
Keywords
Sedentary behavior, Cardiovascular disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor and statistician will be blinded.
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive usual medical care and American Heart Association's Healthy Living booklet
Intervention Type
Behavioral
Intervention Name(s)
Sit Less Program
Intervention Description
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 Outcome Measure Information:
Title
Level of satisfaction with the intervention assessed by the System Usability Scale and exit-interview
Description
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.
Time Frame
Baseline to 12 weeks
Title
Level of compliance with the intervention assessed by number of days the Fitbit device was worn
Description
The compliance with the intervention will be assessed by number of days the Fitbit device was worn per week.
Time Frame
Baseline to 12 weeks
Title
Changes of sedentary behavior assessed by 7 days of activPAL device monitoring
Description
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.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Changes of physical activity measured by 7 days of activPAL device monitoring
Description
Physical activity will be measured by 7 days of activPAL monitoring.
Time Frame
Baseline and 12 weeks
Title
Changes of cardiometabolic biomarkers measured by blood dried spot card
Description
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.
Time Frame
Baseline and 12 weeks
Title
Changes of confidence in reducing sedentary behavior measured by using 6 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.
Description
Confidence in reducing sedentary behavior will be measured using 6 items from the Self-Efficacy Questionnaire for Physical Activity and Sedentary Behavior.
Time Frame
Baseline and 12 weeks
Title
Changes of habit strength for sedentary behavior assessed by using the Self-Report Habit Index.
Description
Habit strength for sedentary behavior will be assessed by 7 items from the Self-Report Sedentary Behavior Habit Index.
Time Frame
Baseline and 12 weeks
Title
Changes of 24-hour glucose levels assessed by continuous glucose monitors
Description
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).
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chorong Park, PhD
Phone
6158755226
Email
chorong.park@vanderbilt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chorong Park, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chorong Park, PhD
Phone
615-875-5226
Email
chorong.park@vanderbilt.edu
First Name & Middle Initial & Last Name & Degree
Abigail Doyle, BS
Phone
6153436075
Email
abigail.m.doyle@vanderbilt.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Reducing Sedentary Time in Patients With Cardiovascular Disease
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