A Behavioural Weight Loss Intervention Delivered in Cardiac Rehabilitation for Patients With Atrial Fibrillation and Obesity: The BeWEL IN CR-AF Study
Trial tests if adding weight loss coaching to heart rehab helps atrial fibrillation patients lose we
Plain English Summary
A Behavioural Weight Loss Intervention Delivered in Cardiac Rehabilitation for Patients With Atrial Fibrillation and Obesity is a Not Applicable clinical trial sponsored by University of Calgary studying Atrial Fibrillation, Obesity. This study tests a new program that combines standard cardiac rehabilitation with a special weight loss coaching program. It is for adults with atrial fibrillation (an irregular heartbeat) and obesity. Participants will attend regular cardiac rehab sessions and weekly online weight loss coaching classes. The alternative is standard cardiac rehabilitation alone. The trial aims to enroll 120 participants.
Official Summary
One-in-four Canadians will be diagnosed with an abnormal heart rhythm called atrial fibrillation (AF) in their lifetime. This is expected to double by 2050, owing to an aging population and increased age- and health behaviour-associated AF risk factors (e.g., poor cardiorespiratory fitness, Type II diabetes, hypertension, and obesity). AF is associated with an increased risk of severe health outcomes including stroke, heart failure, dementia, and death. Nearly three-quarters of people with AF also have obesity (excess body weight). According to research, people with obesity that lose approximately 10% of their body weight can experience relief from uncomfortable AF symptoms. Losing weight may even help people return to a normal heart rhythm. Cardiac rehabilitation (CR) is a proven way to help people with heart disease live longer, healthier lives. So far, research has not shown whether CR helps improve the abnormal heart rhythms seen in AF. This may be because CR programs usually do not offer specific help with weight management. Therefore, adding behavioural weight-loss treatment (BWLT; group classes to change thoughts and behaviours to encourage weight loss) to CR programs may help people with AF and obesity experience relief from their symptoms. This randomized controlled trial will assess whether the combination of an AF-specific 'small changes' BWLT and traditional CR results in a greater proportion of patients with AF and obesity achieving ≥ 10% body weight loss compared to patients who receive standard care (traditional CR alone). Traditional CR consists of participating in exercise sessions, supervised by health professionals, twice per week for 12 weeks. In addition to traditional CR, patients that are randomized to receive BWLT will attend 12 weekly online group therapy classes to learn strategies from psychology to help encourage weight loss. The investigators will collect data pertaining to weight, AF burden, physical activity, and disease-specific and
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with atrial fibrillation or flutter and a BMI of 30 or higher. Individuals who are not currently meeting physical activity goals and can speak and write in English. People with at least one other health condition like sleep apnea, diabetes, high blood pressure, heart failure, or high cholesterol. Those with long-standing or permanent atrial fibrillation, uncontrolled heart disease, or who have recently had or are scheduled for weight loss surgery or AF ablation are not eligible. This trial is studying Atrial Fibrillation, Obesity, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see if more patients in the group receiving both cardiac rehab and weight loss coaching lose at least 10% of their body weight compared to those getting standard cardiac rehab alon The specific primary outcome measures are: Proportion of patients achieving ≥10% body weight change (Baseline, 52 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a significant gap by investigating if a structured weight loss program within cardiac rehabilitation can improve outcomes for patients with atrial fibrillation and obesity, a comm This research targets Atrial Fibrillation, Obesity, where improved treatment options are needed.
Investor Insight
This trial targets a large and growing patient population with atrial fibrillation and obesity, aiming to improve a common comorbidity and potentially reduce healthcare costs associated with AF compli
Is This Trial Right for Me?
Ask your doctor if this trial is a good fit for you, especially regarding your atrial fibrillation and weight. Participation involves attending regular cardiac rehabilitation sessions and weekly online weight loss coaching classes for about 12 weeks, with follow-up for a year. You will have regular check-ins to monitor your weight, heart rhythm, and overall health. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 120 participants
Interventions
- BEHAVIORAL: BWLT+CR — Patients will attend twelve 2-hour group-based weekly sessions (over Zoom) in addition to their twice-weekly CR exercise sessions, followed by biweekly follow-up sessions alternating between individual phone-based sessions with a facilitator, and group-based sessions for an additional 12 weeks. The empirically validated ASPIRE BWLT was recently adapted for an AF population with obesity. Briefly, the BWLT was modified to incorporate education and practical strategies requested by patients, includ
- BEHAVIORAL: CR-Only — The CR program consists of education, medication management, risk factor modification and 12 weeks of twice-weekly supervised cardiovascular exercise sessions. Patients with AF undergo a symptom-limited graded exercise stress test at intake, 12-weeks, 24-weeks, and 1-year post-randomization, where cardiorespiratory fitness (i.e., peak metabolic equivalents \[METS\]) and cardiometabolic risk factors (blood pressure, blood lipid profile, BMI, waist circumference, depression and anxiety symptoms, t
Primary Outcomes
- Proportion of patients achieving ≥10% body weight change (Baseline, 52 weeks)
Secondary Outcomes
- Total Weight Loss (Baseline, 12 weeks, 24 weeks, 52 weeks)
- AF Burden (12 weeks, 24 weeks, 52 weeks)
- AF Symptom Burden (Baseline, 12 weeks, 24 weeks)
- AF-related Quality of Life (Baseline, 12 weeks, 24 weeks)
- Symptoms of Psychological Distress (Baseline, 12 weeks, 24 weeks)
Full Eligibility Criteria
Inclusion Criteria: * Adults of age ≥18 years * Symptomatic paroxysmal or persistent atrial fibrillation or atrial flutter * Classified as obese (BMI ≥30 kg/m2) * Have a sedentary lifestyle (not currently meeting basic physical activity targets of ≥150 minutes/week) * Ability to speak and write in English * Willingness to be referred to a behavioural weight loss treatment (BWLT) * At least one of the following: obstructive sleep apnea, diabetes, hypertension, heart failure, dyslipidemia, CAD, peripheral artery, or cerebrovascular disease. Exclusion Criteria: * Longstanding-persistent (defined as ≥ 3 years continuous AF) or permanent AF * Uncontrolled coronary artery disease * Completed a CR program within the previous year * Currently enrolled in a structured behavioural weight loss program * Currently scheduled to receive catheter ablation in AF * Currently taking GLP-1 receptor agonist or * Received bariatric surgery in the previous year prior to enrollment OR scheduled for bariatric surgery during the study period.
Trial Locations
- Behavioural Medicine Lab, Calgary, Alberta, Canada
Frequently Asked Questions
What is clinical trial NCT05600829?
NCT05600829 is a Not Applicable INTERVENTIONAL study titled "A Behavioural Weight Loss Intervention Delivered in Cardiac Rehabilitation for Patients With Atrial Fibrillation and Obesity." It is currently active, not recruiting and is sponsored by University of Calgary. The trial targets enrollment of 120 participants.
What conditions does NCT05600829 study?
This trial investigates treatments for Atrial Fibrillation, Obesity. The primary condition under study is Atrial Fibrillation.
What treatments are being tested in NCT05600829?
The interventions being studied include: BWLT+CR (BEHAVIORAL), CR-Only (BEHAVIORAL). Patients will attend twelve 2-hour group-based weekly sessions (over Zoom) in addition to their twice-weekly CR exercise sessions, followed by biweekly follow-up sessions alternating between individual phone-based sessions with a facilitator, and group-based sessions for an additional 12 weeks. The empirically validated ASPIRE BWLT was recently adapted for an AF population with obesity. Briefly, the BWLT was modified to incorporate education and practical strategies requested by patients, includ
What does Not Applicable mean for NCT05600829?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05600829?
This trial is currently "Active, Not Recruiting." It started on 2023-06-22. The estimated completion date is 2027-03-30.
Who is sponsoring NCT05600829?
NCT05600829 is sponsored by University of Calgary. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05600829?
The trial aims to enroll 120 participants. The trial status is active, not recruiting.
How is NCT05600829 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT05600829?
The primary outcome measures are: Proportion of patients achieving ≥10% body weight change (Baseline, 52 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05600829 being conducted?
This trial is being conducted at 1 site, including Calgary, Alberta (Canada).
Where can I find official information about NCT05600829?
The official record for NCT05600829 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05600829. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05600829 testing in simple terms?
This study tests a new program that combines standard cardiac rehabilitation with a special weight loss coaching program. It is for adults with atrial fibrillation (an irregular heartbeat) and obesity.
Why is this trial significant?
This trial addresses a significant gap by investigating if a structured weight loss program within cardiac rehabilitation can improve outcomes for patients with atrial fibrillation and obesity, a comm
What are the potential risks of participating in NCT05600829?
Potential side effects are generally related to weight loss efforts and could include fatigue or nutritional deficiencies if not managed properly. As with any cardiac rehabilitation program, there's a small risk of exercise-related complications, though these are closely monitored. The weight loss program may cause temporary changes in mood or energy levels. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05600829?
Ask your doctor if this trial is a good fit for you, especially regarding your atrial fibrillation and weight. Participation involves attending regular cardiac rehabilitation sessions and weekly online weight loss coaching classes for about 12 weeks, with follow-up for a year. You will have regular check-ins to monitor your weight, heart rhythm, and overall health. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05600829 signal from an investment perspective?
This trial targets a large and growing patient population with atrial fibrillation and obesity, aiming to improve a common comorbidity and potentially reduce healthcare costs associated with AF compli This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will attend regular cardiac rehab sessions and weekly online weight loss coaching classes. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.