Behavioral Weight Loss Intervention + Cardiac Rehab for Atrial Fibrillation and Obesity
(BeWEL IN CR-AF Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Calgary
Must not be taking: GLP-1 receptor agonists
Disqualifiers: Longstanding AF, Uncontrolled CAD, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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 generic patient-reported outcomes. This information will determine if taking CR+BWLT helps patients with weight loss and AF symptoms. Further, it will help efforts to provide effective treatment to patients with AF to help participants lose weight and reduce or eliminate AF symptoms.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking GLP-1 receptor agonists.
What data supports the effectiveness of the treatment Behavioral Weight Loss Intervention + Cardiac Rehab for Atrial Fibrillation and Obesity?
Research shows that combining behavioral weight loss programs with cardiac rehabilitation can lead to significant weight loss and improvements in heart health risk factors like blood pressure and cholesterol levels. This approach has been effective in patients with coronary heart disease, suggesting it could also benefit those with atrial fibrillation and obesity.
12345Is the combination of behavioral weight loss intervention and cardiac rehabilitation safe for humans?
Behavioral weight loss interventions and cardiac rehabilitation programs have been shown to be safe for humans, with studies indicating they can lead to weight loss and improvements in health markers like blood pressure and cholesterol levels.
14678How is the Behavioral Weight Loss Intervention + Cardiac Rehab treatment different from other treatments for atrial fibrillation and obesity?
This treatment is unique because it combines behavioral weight loss therapy, which focuses on changing eating and activity habits, with cardiac rehabilitation, a program designed to improve heart health. This dual approach not only targets weight loss but also enhances cardiovascular health, making it particularly suitable for patients with both atrial fibrillation and obesity.
910111213Eligibility Criteria
This trial is for adults over 18 with atrial fibrillation or flutter and obesity (BMI ≥30), leading a sedentary lifestyle. They must speak English and be open to weight loss treatment, but can't have done similar programs or had bariatric surgery recently, nor should they have uncontrolled heart issues or be on certain medications.Inclusion Criteria
I am 18 years old or older.
I experience sudden or ongoing irregular heartbeats.
I do not exercise for at least 150 minutes a week.
+4 more
Exclusion Criteria
I am scheduled for a procedure to correct my irregular heartbeat.
I am currently on GLP-1 receptor agonist medication.
I had or will have weight-loss surgery within a year of joining the study.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants engage in a 12-week outpatient cardiac rehabilitation program with or without additional weekly behavioural weight loss classes
12 weeks
24 visits (in-person)
Follow-up
Participants are monitored for weight loss, AF burden, and other health outcomes
40 weeks
3 visits (in-person)
Long-term Follow-up
Participants' weight loss and AF symptoms are assessed at 52 weeks post-randomization
12 weeks
Participant Groups
The study tests if adding a 'small changes' behavioural weight-loss program to standard cardiac rehab helps patients with atrial fibrillation and obesity lose more weight. Participants will either do regular exercise sessions in cardiac rehab or combine this with online group therapy classes for weight loss.
2Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Patients participate in a traditional 12-week outpatient CR program with added weekly behavioural weight loss classes.
Group II: ControlExperimental Treatment1 Intervention
Patients participate in a traditional 12-week outpatient CR program.
BWLT is already approved in Canada, United States for the following indications:
🇨🇦 Approved in Canada as Behavioural Weight Loss Treatment for:
- Weight loss in patients with atrial fibrillation and obesity
🇺🇸 Approved in United States as Behavioural Weight Loss Treatment for:
- Weight management in cardiac rehabilitation settings
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
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Who Is Running the Clinical Trial?
University of CalgaryLead Sponsor
Alberta Health servicesCollaborator
University of British ColumbiaCollaborator
References
Weight Loss and Its Predictors During Participation in Cardiac Rehabilitation. [2022]We aimed to assess the prevalence and magnitude of clinically meaningful weight loss among cardiac rehabilitation (CR) participants who were overweight or obese and identify its predictors. We analyzed subjects with body mass index (BMI) ≥25 who were enrolled in a 12-week CR outpatient program from January 1, 2015, to December 31, 2019, and had paired pre- and post-CR weight data. Patients who lost 3% or more of their body weight by the end of the program were compared with the remaining participants. Multivariable logistic regression was used to determine predictors of weight loss. Overall, 129 of 485 subjects (27%) with overweight or obesity reduced their weight by at least 3% (average percent weight change: -5.0% ± 1.8% vs -0.02% ± 2.2%, average weight change: -10.9 ± 5.0 vs -0.1 ± 4.4 pounds, and average BMI change: -1.7 ± 0.7 vs -0.02 ± 0.7 kg/m2). Compared with the remaining 356 patients, those who achieved the defined weight loss were younger (p = 0.016) and had higher baseline weight (p = 0.002) and BMI (p <0.001). The weight loss group tended to be enrolled more likely for an acute myocardial infarction or percutaneous coronary intervention (p <0.001) and less likely for coronary artery bypass grafting (p = 0.001) or a heart valve procedure (p = 0.05). By the end of the CR program, the weight loss group demonstrated a greater increase in Rate Your Plate - Heart score (7 [3, 11] vs 4 [1, 8]; p <0.001) and a greater decrease in triglycerides (-20 ± 45 vs -7 ± 55 mg/dL; p = 0.026) and glycated hemoglobin (-0.1 [-0.5, 0.1] vs 0.1 [-0.3, 0.4] %; p = 0.05, among patients with diabetes or prediabetes). In a multivariable logistic regression model, baseline predictors of clinically meaningful weight loss included higher BMI and not being enrolled for a surgical CR indication (p = 0.001). In conclusion, throughout 12 weeks of CR participation, 129 of 485 subjects (27%) with BMI ≥25 had a 3% or more reduction in body weight. Patients with higher baseline BMI and participants without a surgical enrollment diagnosis were more likely to achieve the defined weight loss. Efforts to improve CR referral and enrollment for eligible patients with overweight and obesity should be encouraged, and suitable and efficient weight reduction interventions in CR settings need to be further studied.
Degree and Direction of Change of Body Weight in Cardiac Rehabilitation and Impact on Exercise Capacity and Cardiac Risk Factors. [2017]Cardiac rehabilitation (CR) improves functional capacity and reduces mortality in patients with cardiovascular disease. It also improves cardiovascular risk factors and aids in weight reduction. Because of the increase in morbidly obese patients with cardiovascular disease, the prevalence of obesity and patterns of weight change in those undergoing CR merit fresh study. We studied 1,320 participants in a 12-week CR program at our academic medical center. We compared 5 categories: 69 class III obese (body mass index [BMI] ≥40) patients, 128 class II obese patients (BMI 35.0 to 39.9), 318 class I obese patients (BMI 30.0 to 34.9), 487 overweight patients (BMI 25.0 to 29.9), and 318 normal weight patients (BMI 18.5 to 24.9). Exercise capacity in METs, weight, blood pressure, and fasting lipid profile were measured before and after CR. Overall, 131 patients gained weight, 827 had no significant weight change, and 363 lost weight (176 lost 3% to 5% of their baseline weight, 161 lost 5% to 10%, and 26 lost >10%). Exercise capacity, blood pressure, and low-density lipoprotein cholesterol improved in all patients. Class III obese patients had the smallest improvement in peak METs (p 10% of their baseline weight had the greatest improvements in exercise capacity, low-density lipoprotein, and triglycerides. In conclusion, after CR, a minority of patients lost weight. Most patients had no significant weight change and some even gained weight. The greatest loss was seen in class III obese patients. All patient groups showed improvements in exercise capacity and risk factors, regardless of the direction or degree of weight change.
Weight loss in the clinical setting: applications for cardiac rehabilitation. [2019]Obese coronary patients could benefit significantly from weight reduction. Unfortunately, weight management is not considered a standard component of cardiac rehabilitation programs. This article reviews the characteristics, approach and outcome data for behavioral weigh loss programs. Strategies for implementing a behavior modification treatment as part of a cardiac rehabilitation program are discussed.
Obesity in coronary heart disease: An unaddressed behavioral risk factor. [2018]Obesity is an independent risk factor for the development and progression of coronary heart disease (CHD). Over 80% of patients with CHD are overweight or obese. While obesity is often considered a relatively "minor" CHD risk factor, weight loss is a broadly effective risk-factor intervention. Weight loss can profoundly influence a number of "major" risk factors including: hypertension, dyslipidemia and insulin resistance/type 2 diabetes mellitus. Despite its prominence as a risk factor most cardiac rehabilitation (CR) programs do not have a specific, targeted intervention to assist patients with weight loss. Consequently, the weight loss that occurs during CR is quite small and unlikely to appreciably alter risk factors. Relying on CR associated exercise as a sole intervention is an ineffective strategy to promote weight loss. There is evidence, however, that behavioral weight loss (BWL) interventions can be effectively employed in the CR setting. In contrast to programs that do not offer a targeted intervention, studies show that participants in CR-related BWL programs lose significantly more weight. The additional weight loss from the BWL intervention is associated with greater improvements in insulin sensitivity and other components of the metabolic syndrome such as hypertension and lipid abnormalities. As a means of maximizing CHD risk factor reduction CR programs need to incorporate BWL programs as a standard programming for overweight/obese patients.
Obese patients' characteristics and weight loss outcomes in cardiac rehabilitation: An observational study of registry data. [2021]Cardiac rehabilitation (CR) guidelines advocate weight loss for obese patients but mean weight loss is small. We sought to determine the extent to which obese patients' characteristics prior to CR predict weight loss.
Targeting Obesity to Optimize Weight Loss in Cardiac Rehabilitation: A PILOT STUDY. [2023]Cardiac rehabilitation (CR) programs are integral in the treatment of coronary heart disease (CHD). However, most programs do not incorporate structured, evidence-based obesity treatment, potentially limiting efficacy for the large number of CHD patients with overweight/obesity. This pilot study determined the feasibility of adding a behavioral weight loss intervention during standard CR.
[Hallmarks of preventive counseling in coronary heart disease patients with abdominal obesity]. [2019]Patients with coronary heart disease (CHD) and abdominal obesity (AO) are a priority group for the most active implementation of secondary prevention efforts. The paper focuses on most challenging issues of cardiovascular risk factors (RFs) correction via comprehensive cardiac rehabilitation (CR) programs in patients with CHD and AO. Based on large randomized clinical trials results, intensive behavioral interventions in the form of counselling are beneficial for such patients especially during the long-term support stage. They produce small but important changes in health behaviors (which translate into weight reduction, more healthy nutrition and higher physical activity) and improve selected intermediate clinical endpoints.
Smartphone-supported behavioural weight loss treatment in adults with severe obesity: study protocol for an exploratory randomised controlled trial (SmartBWL). [2023]Label="INTRODUCTION">Behavioural weight loss (BWL) treatment is the standard evidence-based treatment for severe obesity (SO; body mass index ≥40.0 kg/m2 or ≥35.0 kg/m2 with obesity-related comorbidity), leading to moderate weight loss which often cannot be maintained in the long term. Because weight loss depends on patients' use of weight management skills, it is important to support them in daily life. In an ecological momentary intervention design, this clinical trial aims to adapt, refine and evaluate a personalised cognitive-behavioural smartphone application (app) in BWL treatment to foster patients' weight management skills use in everyday life. It is hypothesised that using the app is feasible and acceptable, improves weight loss and increases skills use and well-being.
Multidisciplinary approach to adult obesity therapy. [2014]A comprehensive program has been designed to treat medically significant obesity (body mass index greater than 30). The essential components include nutritional education, exercise, mental conditioning, relaxation and assertiveness training. Adherence to this combined program is supported by rapid weight loss utilizing a protein-sparing modified fast. Initial efforts include greater than 18 kg (40 lb) weight loss in three out of four patients and greater than two years maintenance in one out of three patients. The varying success depends on patient adherence to a prolonged education program at least six months to one year directed at modification of lifestyle. Both for lasting safety and effectiveness a professional partnership is required between the physician and patient. Finally the result of therapy appears to be rehabilitation and not cure from the problem of obesity.
Behavioral treatment of obesity. [2019]The behavioral treatment of obesity consists of a set of principles and techniques to help overweight individuals modify inappropriate eating and activity habits. As provided in University and hospital clinics, this approach produces an average loss of 8.5 kg (9% of initial weight) in approximately 20 weeks. The maintenance of weight loss is facilitated by the provision of long-term patient-provider contact as well as by the use of weight-loss medications. The most promising results are likely to be obtained when behavioral and pharmacologic approaches are combined. The article concludes with a discussion of the importance of treating obese individuals with respect and compassion.
Successful management of the obese patient. [2019]Obesity is a chronic disease that affects a substantial number of Americans. Obesity significantly increases a person's risk of cardiovascular diseases and morbidity. Modification of lifestyle behaviors that contribute to obesity (e.g., inappropriate diet and inactivity) is the cornerstone of treatment. Behavior modification involves using such techniques as self-monitoring, stimulus control, cognitive restructuring, stress management and social support to systematically alter obesity-related behaviors. In addition, adjunctive pharmacotherapy can play an important role in the routine medical management of obesity.
Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. [2021]Behavioural weight loss programs are effective first-line treatments for obesity and are recommended by the US Preventive Services Task Force. Gaining an understanding of intervention components that are found helpful by different demographic groups can improve tailoring of weight loss programs. This paper examined the perceived helpfulness of different weight loss program components.
Personalized cognitive-behavioural therapy for obesity (CBT-OB): theory, strategies and procedures. [2020]Personalized cognitive-behavioural therapy for obesity (CBT-OB) is a new treatment that combines the traditional procedures of standard behavioural therapy for obesity (i.e., self-monitoring, goal setting, stimulus control, contingency management, behavioural substitution, skills for increasing social support, problem solving and relapse prevention) with a battery of specific cognitive strategies and procedures. These enable the treatment to be individualized, and to help patients to address the cognitive processes that previous research has found to be associated with treatment discontinuation, the amount of weight lost and long-term weight-loss maintenance. The treatment programme can be delivered at three levels of care, outpatient, day hospital and residential, and includes six modules, which are introduced according to the individual patient's needs as part of a flexible, personalized approach. The primary goals of CBT-OB are to help patients to (i) achieve, accept and maintain healthy weight loss; (ii) adopt a lifestyle conducive to weight control; and (iii) develop a stable "weight-control mindset". A randomized controlled trial has found that 88 patients suffering from morbid obesity treated with CBT-OB followed a period of residential treatment achieved a mean weight loss of 15% after 12 months, with no tendency to regain weight between 6 and 12 months. The treatment efficacy is also supported by data from a study assessing the effects of group CBT-OB delivered in a real-world clinical setting. In that study, 77 patients with morbid obesity who completed the treatment achieved 9.9% weight loss after 18 months. These promising results, if confirmed by future clinical studies, suggest that CBT-OB has the potential to be more effective than traditional weight-loss lifestyle-modification programmes.