Behavioral Weight Loss Intervention + Cardiac Rehab for Atrial Fibrillation and Obesity

(BeWEL IN CR-AF Trial)

Overseen By Braiden Valdarchi, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: GLP-1 receptor agonists

Disqualifiers: Longstanding AF, Uncontrolled CAD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 27

Duration: 12 weeks

120 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 4 6 7 8}

How 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. ^{9 10 11 12 13}

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.

Research Team

Tavis Campbell, PhD

Principal Investigator

University of Calgary

Eligibility 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 experience sudden or ongoing irregular heartbeats.

I do not exercise for at least 150 minutes a week.

I have at least one condition like sleep apnea, diabetes, high blood pressure, heart failure, high cholesterol, heart disease, or artery problems.

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.

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

Treatment Details

Interventions

• BWLT
• CR

Trial Overview 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.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Patients participate in a traditional 12-week outpatient CR program with added weekly behavioural weight loss classes.

Group II: Control Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Findings from Research

In a 12-week cardiac rehabilitation program, 27% of participants with a BMI of 25 or higher achieved a clinically meaningful weight loss of at least 3%, averaging a 5% reduction in body weight.

Predictors of successful weight loss included having a higher baseline BMI and not being enrolled for surgical reasons, suggesting that targeted interventions could enhance weight loss outcomes in cardiac rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss and Its Predictors During Participation in Cardiac Rehabilitation. Hushcha, P., Jafri, SH., Malak, MM., et al.[2022]

In a study of 1,320 participants undergoing a 12-week cardiac rehabilitation program, most patients did not experience significant weight change, with 131 gaining weight, while class III obese patients (BMI ≥40) showed the greatest weight loss despite having the smallest improvement in exercise capacity.

All patient groups, regardless of weight change, demonstrated improvements in exercise capacity, blood pressure, and low-density lipoprotein cholesterol, indicating that cardiac rehabilitation is effective in enhancing cardiovascular health even if weight loss is not achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Degree and Direction of Change of Body Weight in Cardiac Rehabilitation and Impact on Exercise Capacity and Cardiac Risk Factors. Gomadam, PS., Douglas, CJ., Sacrinty, MT., et al.[2017]

Obese patients with coronary heart disease can greatly benefit from weight loss, which is currently not a standard part of cardiac rehabilitation programs.

The article discusses effective behavioral weight loss strategies that could be integrated into cardiac rehabilitation to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss in the clinical setting: applications for cardiac rehabilitation. Harvey-Berino, J.[2019]

Obesity significantly increases the risk of coronary heart disease (CHD), with over 80% of CHD patients being overweight or obese, highlighting the need for effective weight loss interventions in cardiac rehabilitation (CR) programs.

Behavioral weight loss (BWL) interventions in CR settings lead to significantly greater weight loss compared to standard programs, resulting in improved insulin sensitivity and reductions in hypertension and lipid abnormalities, making BWL a crucial component for managing CHD risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity in coronary heart disease: An unaddressed behavioral risk factor. Ades, PA., Savage, PD.[2018]

In a study of 29,601 obese patients undergoing cardiac rehabilitation, the average weight loss was modest, with men losing 0.9 kg and women losing 0.5 kg, highlighting the challenge of achieving significant weight loss in this population.

Certain characteristics, such as smoking cessation, diabetes, and low fitness levels, were found to predict less weight loss, while higher initial weight and being employed were associated with greater weight loss, suggesting that personalized approaches to weight management in cardiac rehabilitation could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obese patients' characteristics and weight loss outcomes in cardiac rehabilitation: An observational study of registry data. Wilkinson, JA., Harrison, AS., Doherty, P.[2021]

In a pilot study involving 38 adults with coronary heart disease (CHD) and obesity, adding a behavioral weight loss intervention to standard cardiac rehabilitation (CR) significantly improved weight loss (6.4% vs. 1.2%) and fat loss compared to CR alone.

The intervention was well-received, with a high retention rate of 95% and 98% attendance at weight loss sessions, indicating that integrating weight management into CR is both feasible and beneficial for enhancing self-efficacy and weight management behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Obesity to Optimize Weight Loss in Cardiac Rehabilitation: A PILOT STUDY. Brinkley, TE., Hsu, FC., Bowman, BM., et al.[2023]

Intensive behavioral interventions, such as counseling, are effective in promoting long-term health behavior changes in patients with coronary heart disease and abdominal obesity, leading to weight reduction, healthier eating, and increased physical activity.

These comprehensive cardiac rehabilitation programs have been shown to improve key clinical outcomes, highlighting their importance in secondary prevention efforts for this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hallmarks of preventive counseling in coronary heart disease patients with abdominal obesity]. Pogosova, NV., Sokolova, OY., Salbieva, AO., et al.[2019]

This clinical trial will evaluate a personalized cognitive-behavioral smartphone app designed to support behavioral weight loss (BWL) treatment in 90 adults with severe obesity over 6 months, aiming to improve weight management skills and overall well-being.

The primary outcome will measure weight loss at 6 months compared to pretreatment, while secondary outcomes will assess the app's feasibility, acceptance, and its impact on weight management skills and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-supported behavioural weight loss treatment in adults with severe obesity: study protocol for an exploratory randomised controlled trial (SmartBWL). Hilbert, A., Juarascio, A., Prettin, C., et al.[2023]

The comprehensive obesity treatment program, which includes nutritional education, exercise, and mental conditioning, resulted in significant weight loss, with over 18 kg (40 lb) lost by three out of four patients.

Long-term success in maintaining weight loss requires patient adherence to lifestyle modifications over six months to a year, highlighting the importance of a strong partnership between the physician and patient for effective rehabilitation rather than a complete cure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary approach to adult obesity therapy. Blackburn, GL., Greenberg, I.[2014]

Behavioral treatment for obesity can lead to an average weight loss of 8.5 kg (about 9% of initial weight) over approximately 20 weeks, highlighting its efficacy in helping individuals change unhealthy habits.

Combining behavioral strategies with weight-loss medications enhances the chances of successful weight maintenance, emphasizing the importance of a comprehensive approach to obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatment of obesity. Wadden, TA., Foster, GD.[2019]

Lifestyle modifications, including changes in diet and increased physical activity, are essential for treating obesity and reducing the risk of related cardiovascular diseases.

Behavior modification techniques, such as self-monitoring and cognitive restructuring, are effective strategies for changing obesity-related behaviors, and medication can also support these lifestyle changes in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful management of the obese patient. Poston, WS., Foreyt, JP.[2019]

In a study of 236 participants from the POWER Hopkins Trial, individual telephone sessions, online weight tracking, and coach reviews were rated as the most helpful components of a behavioral weight loss program, indicating their effectiveness in supporting weight loss efforts.

Demographic factors influenced perceptions of helpfulness, with older adults, Black participants, and those with lower education levels finding the intervention components more beneficial, suggesting the need for tailored approaches in weight loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. Dalcin, AT., Jerome, GJ., Fitzpatrick, SL., et al.[2021]

A randomized controlled trial showed that 88 patients with morbid obesity lost an average of 15% of their body weight after 12 months of personalized cognitive-behavioral therapy for obesity (CBT-OB), with no weight regain observed between 6 and 12 months.

In a real-world clinical setting, 77 patients who completed group CBT-OB achieved a 9.9% weight loss after 18 months, indicating that CBT-OB may be more effective than traditional weight-loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized cognitive-behavioural therapy for obesity (CBT-OB): theory, strategies and procedures. Dalle Grave, R., Sartirana, M., Calugi, S.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Weight Loss and Its Predictors During Participation in Cardiac Rehabilitation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Degree and Direction of Change of Body Weight in Cardiac Rehabilitation and Impact on Exercise Capacity and Cardiac Risk Factors. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Weight loss in the clinical setting: applications for cardiac rehabilitation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Obesity in coronary heart disease: An unaddressed behavioral risk factor. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Obese patients' characteristics and weight loss outcomes in cardiac rehabilitation: An observational study of registry data. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Targeting Obesity to Optimize Weight Loss in Cardiac Rehabilitation: A PILOT STUDY. [2023]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Hallmarks of preventive counseling in coronary heart disease patients with abdominal obesity]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Smartphone-supported behavioural weight loss treatment in adults with severe obesity: study protocol for an exploratory randomised controlled trial (SmartBWL). [2023]

9. England pubmed.ncbi.nlm.nih.gov

Multidisciplinary approach to adult obesity therapy. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Behavioral treatment of obesity. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Successful management of the obese patient. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Personalized cognitive-behavioural therapy for obesity (CBT-OB): theory, strategies and procedures. [2020]