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

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 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.

Conditions

• Atrial Fibrillation
• Obesity

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, including AF risk factor management, pathophysiology, medications, and disease course; exercising with AF; and coping with difficult emotions regarding AF. Weekly treatment goals focus on nutrition and moderate calorie reduction while emphasizing adherence to an individualized CR exercise prescription. The BWLT program will be delivered by senior clinical psychology PhD students and supervised by a registered Clinical Health Psychologist.

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, tobacco use, and exercise volume) are assessed.

Sponsors & Collaborators

• Alberta Health services

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Tavis Campbell, PhD · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-22

Primary Completion

2026-12-30

Completion

2027-03-30

Countries

• Canada

Study Locations