Active not recruitingNAINTERVENTIONAL

A Behavioural Weight Loss Intervention Delivered in Cardiac Rehabilitation for Patients With Atrial Fibrillation and Obesity

This study is for people who have both atrial fibrillation (AF), which is a common irregular heartbeat, and obesity. Many people with AF also have obesity, and losing weight can often help improve AF symptoms and even restore a normal heart rhythm. Currently, heart rehabilitation (CR) helps people with heart conditions but doesn't usually focus on weight loss. This trial will test if combining special online weight loss classes with standard CR helps people with AF and obesity lose at least 10% of their body weight more effectively than CR alone. Researchers will look at weight changes, AF symptoms, and how participants feel overall to see if this combined approach leads to better health outcomes.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Calgary

Enrolment target

120

Start

22 Jun 2023

Estimated completion

30 Mar 2027

Atrial Fibrillation Obesity

What is this study about?

If you have atrial fibrillation (AF), an irregular heartbeat, and also live with obesity, this study might be of interest to you. AF is a very common heart rhythm problem, and it's expected to become even more so. It can increase your risk of serious health issues like stroke, heart failure, and memory problems. Interestingly, many people with AF also have obesity, and research suggests that losing about 10% of your body weight can significantly reduce AF symptoms and may even help your heart return to a normal rhythm.

We know that cardiac rehabilitation (CR) programs are excellent for helping people with heart conditions live longer, healthier lives. However, these programs typically don't include much focus on weight management. This study aims to find out if adding a special weight-loss program to standard CR would make a bigger difference for people with AF and obesity. The weight-loss program involves group classes where you learn strategies to help you make small changes to your thoughts and behaviours to encourage weight loss.

In this study, participants with AF and obesity will either receive the standard cardiac rehabilitation program alone or the standard program combined with the new weight-loss classes. Researchers will then compare how much weight people lose, how their AF symptoms change, and how active they become. This information will help doctors understand the best ways to support people with AF and obesity, helping them manage their weight and improve their heart health.

Key takeaways

Atrial fibrillation (AF) is a common irregular heartbeat, often linked with obesity.
Losing weight can significantly improve AF symptoms and heart rhythm.
This study combines heart rehabilitation with online weight loss classes.
It aims to see if this combined approach leads to better weight loss and AF symptom relief.
Researchers will track weight, AF activity, and overall well-being.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have been diagnosed with atrial fibrillation (an irregular heartbeat) that causes symptoms. You also need to have obesity, which means your Body Mass Index (BMI) is 30 or higher. You should typically lead a less active lifestyle, meaning you don't currently get at least 150 minutes of physical activity per week, and be able to speak and write in English. You also need to have at least one other health condition like sleep apnea, diabetes, high blood pressure, heart failure, high cholesterol, or certain other heart or blood vessel issues.

There are also some reasons why you might not be able to join. For example, if your AF has been continuous for a very long time (3 years or more) or is permanent, or if you have uncontrolled heart artery disease. You also can't have completed a cardiac rehabilitation program in the last year, be currently in another structured weight loss program, or be scheduled for a special heart procedure called a catheter ablation for AF. Finally, if you're taking certain weight-loss medications (GLP-1 receptor agonists) or have had weight-loss surgery in the last year, or are planning to have it during the study, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have symptomatic atrial fibrillation or an irregular heartbeat?
Do you have obesity (BMI of 30 or more)?
Are you generally not very active (less than 150 minutes of exercise a week)?
Can you speak and write in English?
Do you have another listed health condition (e.g., diabetes, high blood pressure)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will go through a 12-week program. Everyone in the study will take part in traditional cardiac rehabilitation (CR), which involves attending exercise sessions twice a week, supervised by health professionals. Some participants will also be randomly chosen to receive an extra set of 12 online group therapy classes. These classes will teach you strategies to help with weight loss.

Throughout the study, researchers will collect information about your weight, how much atrial fibrillation you experience, your physical activity levels, and how your overall health and well-being are improving. This information will help them understand the benefits of the different approaches. The exact number of visits for assessments will be explained, but the main treatments involve weekly sessions over 12 weeks. You are free to withdraw from the study at any time.

Potential risks and benefits

Participating in this study might offer several potential benefits, such as gaining access to a structured cardiac rehabilitation program and, for some, a weight-loss program, which could lead to improved heart health, weight loss, and a reduction in AF symptoms. There are always some potential risks with any study, such as the usual risks associated with exercise or the time commitment required for attending sessions. Researchers will monitor your health closely to ensure your safety. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Behavioural Medicine Lab
Verified postcode
Calgary, Canada

Common questions

What is atrial fibrillation (AF)?

Atrial fibrillation is a common type of irregular and often very fast heartbeat that can make you feel breathless, tired, or dizzy.

Why is losing weight important for AF?

Research shows that losing around 10% of your body weight can help reduce AF symptoms and might even help your heart rhythm return to normal.

What is cardiac rehabilitation (CR)?

Cardiac rehabilitation is a supervised program that includes exercise, education, and support to help people with heart conditions recover and improve their health.

Will I have to pay to join the study?

Clinical trials generally do not charge participants. Any costs for study-related treatments and assessments are usually covered by the study organizers.

What happens if I want to stop participating?

You are free to leave the study at any time, for any reason, and it will not affect your routine medical care.