Be WEL

The purpose of this research study is to test if a BWLT program modified for people with AFib will result in a greater amount of CR patients losing 10% of their body weight compared to CR patients that receive treatment as usual. We also want to know if people who take part in BWLT experience any changes in AFib symptoms, related health outcomes, and psychological health.

Typical CR programs often do not include a dedicated weight loss component, which is especially important for patients with higher body weight. This study will help determine the most appropriate treatment for people with both AFib and higher body weight.

If you join this study, you will be randomly chosen to participate in either the 12-week TotalCardiology Rehabilitation (TCR) program or a 24-week virtual BWLT program in addition to the 12-week TCR program.

The TCR program consists of education regarding your medication and risk factors, and 12 weeks of twice-weekly supervised cardiovascular exercise sessions. These sessions will take place at the MNP Community & Sport Centre Gym (located at 2225 Macleod Trail SE, Calgary) and involve aerobic-based exercises using machines like treadmills, ellipticals, and bicycles. The sessions will be individual in nature and range from 15-60+ minutes based on your fitness level. Additionally, you will undergo an exercise stress test before you start the program and then after 12 weeks, 24 weeks, and 1 year, where your health and risk factors will be assessed.

The BWLT program consists of twelve 2-hour group-based weekly sessions that are provided virtually using Zoom videoconferencing software. You will need to have a computer or smartphone with a camera and microphone to take part. After the first 12 weeks, there will be six biweekly follow-up sessions. These sessions will alternate between individual phone-based sessions and group-based sessions, for an additional 12 weeks. You will also need to be physically within the province of Alberta while you take part in the BWLT sessions. The BWLT sessions will cover nutrition, physical activity, sleep, stress, body image, and more. In each session, you will be asked to set health goals and make small changes to your health habits to encourage weight loss. You will also be asked to weigh yourself weekly using a smart scale. A FitBit Aria Air scale will be provided to you for the duration of the study.

Everybody participating in the study will also be given an AliveCor^TM KardiaMobile device for daily heart monitoring. You will be instructed on its use, which will involve recording two separate 30-second electrocardiograms (ECGs) twice a day. The purpose of these recordings is to measure your AFib burden. You will also be asked to wear a fitness tracker so that we can track your daily step count. A FitBit Charge 5 fitness tracker will be provided to you for the duration of the study. In order to use these devices, you will be required to download two mobile applications: the Fitbit app and the Kardia app. The study team will set up FitBit accounts on your behalf and provide instructions on creating Kardia accounts. The study team will have access to the data that is collected by the KardiaMobile device, Fitbit Charge 5, and Aria Air scale. You will be expected to return all the devices at the end of the study.  

Additionally, you will be asked to complete a series of questionnaires three times during this study: before you start the 12-week BWLT program or treatment as usual, at the end of the first 12-weeks, and at the very end of the study (approximately 24-weeks). The questionnaires will ask about your mood, your AF symptoms, your eating habits, and your quality of life. The questionnaires also ask for some personal information (e.g., marital status, income, race) so we can describe the group of people who completes this study. Each questionnaire package will take about 25 minutes to complete. If you joined this study after being referred from TotalCardiology, the study team may also obtain or verify information about your diagnosis, rehabilitation, risk factors, and treatments from your TotalCardiology Rehabilitation medical chart.

All participants in the study will also be completing a sociodemographic questionnaire at the beginning of the study to determine data such as age, sex, gender identity, race/ethnicity, income, and education.

At the end of the full 24-week program you will be asked to fill out the same questionnaires that you completed at the start of the study, and answer some questions about your satisfaction with the BWLT program. Afterwards, you will not have to do anything else for the study. If you found the BWLT beneficial, you are free to use the materials to continue the exercise and eating habits you learned on your own.

There are very few risks to taking part in this study. You may be asked to talk about your weight or physical and emotional problems you are experiencing. This can be uncomfortable or distressing to some people. You may pass on any question you do not feel comfortable answering. If you have health questions beyond the scope of this study, the researcher will connect you to other resources (as appropriate) which might include your CR team, your doctor, emergency services, and/or community supports.

In terms of physical risks, you may feel physical stress or fatigue while taking part in the TCR program. Medical supervision of CR exercise sessions is a key component of the TCR program. Given the professional instruction and supervision that you will receive when performing exercises, the risk for injuries is extremely low. Should any injuries or health concerns arise, the researcher will connect you to other resources (as appropriate) which might include your CR team, your doctor, emergency services, and/or community supports.

If you agree to take part in this study, you may feel better emotionally or lose a moderate amount of weight. Weight loss has been shown to improve AF symptoms in past studies, therefore you may experience some relief from your AF symptoms. It is possible you will not experience any benefits.