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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
24
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
Vanderbilt University
Nashville, Tennessee, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 weeks
Changes of physical activity measured by 7 days of activPAL device monitoring
Physical activity will be measured by 7 days of activPAL monitoring.
Time frame: Baseline and 12 weeks
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.
Time frame: 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.
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
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.
Time frame: Baseline and 12 weeks
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).
Time frame: Baseline and 12 weeks
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