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

NCT05600829 | Active Not Recruiting DMC

• 1 other identifier: REB22-0976
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving ≥10% body weight change

  Assessed by dividing the number of kilograms at 52 weeks by the initial (T1) kg and multiplying by 100%.

  Baseline, 52 weeks

Secondary Outcomes (8)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: BWLT+CR

Control

OTHER

Patients participate in a traditional 12-week outpatient CR program.

Behavioral: CR-Only

Interventions

BWLT+CR 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, 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.

Intervention

CR-Only BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator
• University of British Columbia: collaborator

Study Sites (1)

Behavioural Medicine Lab

Calgary, Alberta, Canada

Location

Related Publications (1)

• Williamson TM, Rouleau CR, Wilton SB, Valdarchi AB, Moran C, Patel S, Lutes L, Aggarwal SG, Arena R, Campbell TS. A randomized controlled trial of a "Small Changes" behavioral weight loss treatment delivered in cardiac rehabilitation for patients with atrial fibrillation and obesity: study protocol for the BE-WEL in CR-AF study. Trials. 2024 Oct 11;25(1):671. doi: 10.1186/s13063-024-08527-6.

  PMID: 39394158 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Obesity

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Tavis Campbell, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 1, 2022
• Study Start: June 22, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)