Acceptability of the Small Changes Behavioural Weight Loss Approach for Patients with Atrial Fibrillation and Obesity in Cardiac Rehabilitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Calgary
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Intervention Feasibility
Study Overview
Brief Summary
One-in-four Canadians will be diagnosed with an abnormal heart rhythm called atrial fibrillation (AF) in their lifetime. People with AF have an increased chance of having serious medical problems like stroke and heart failure. 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 study will test a new BWLT provided within a traditional CR program. Patients who have AF and obesity will take traditional CR with added BWLT. Traditional CR consists of participating in exercise sessions, supervised by health professionals, twice per week for 12 weeks. In addition to exercising, patients will complete 12 online group therapy classes to learn strategies from psychology to help them lose weight. After patients complete the 12 week program the investigators will collect patients' perspectives on the program in order to make changes if needed before testing BWLT in a larger group of people. The investigators will also weigh patients and measure their AF symptoms before and after the program to determine if taking CR+BWLT helps with weight loss and AF symptoms. This research will help efforts to provide effective treatment to patients with AF to help them lose weight and reduce or eliminate AF symptoms.
Detailed Description
Background: One-in-four Canadians will develop atrial fibrillation (AF), increasing risk of heart failure and stroke. Obesity (i.e., BMI ≥30 kg/m2) represents a strong, independent risk factor for increased incidence and severity of AF. Weight loss reduces AF symptom burden, and patients with obesity who lose ≥10% of their body weight may achieve AF regression/remission. Cardiac rehabilitation (CR) improves AF risk factors including hypertension and cardiorespiratory fitness (CRF), yet the efficacy of CR for reducing AF symptom burden is not established. CR rarely includes targeted obesity management and, on average, has a negligible impact on BMI. Adding behavioural weight-loss treatment (BWLT) to traditional CR may therefore enhance weight loss and lead to improvements in AF prognosis, symptoms, and health-related quality-of-life (HRQOL) in patients with AF and obesity.
A recent qualitative investigation of potential barriers and facilitators to patient uptake of a BWLT+CR intervention demonstrated that a combined CR+BWLT program is desirable to patients with AF and obesity. Results of this study will be used to adapt the existing small changes BWLT to meet the unique needs of this patient population prior to testing the intervention. Demonstrating that an AF adapted-version of the BWLT, delivered during a traditional 12-week CR program, is acceptable to patients with AF and comorbid obesity is a necessary next-step in intervention development, prior to testing the intervention in randomized designs.
The primary aim is to: Demonstrate acceptability of an adapted 12-week BWLT program, provided in the context of 12-weeks of exercise-based CR, among patients with AF and obesity.
The secondary aims of the proposed study are to: (a) Evaluate the feasibility of the fixed BWLT protocol in terms of recruitment, retention, drop out rates, treatment protocol adherence (by interventionists), and intervention adherence (attendance at BWLT and CR completion), and (b) evaluate potential improvements in weight, AF symptom burden, and psychological distress (depression, anxiety) from pre- to post-BWLT+CR program.
Hypotheses:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18+ years
- •symptomatic, electrocardiogram (ECG)-documented paroxysmal (i.e., ≥2 AF episodes within a 6 month period) or persistent (i.e., AF episodes lasting ≥7 days) AF
- •obesity (i.e., BMI ≥30 kg/m2)
- •able to read and write in English to be eligible.
Exclusion Criteria
- •longstanding-persistent (i.e., ≥ 3 years continuous AF) or permanent AF;
- •uncontrolled CAD;
- •currently enrolled in a concurrent weight loss program, and;
- •currently scheduled to receive catheter ablation treatment for AF.
Outcomes
Primary Outcomes
Intervention Feasibility
Time Frame: Post-intervention (12 weeks)
Adherence to the intervention will be determined by chart review. Referral rates of eligible patients from the AF clinic will be recorded. Drop-outs will be recorded, including reasons for study drop-out if available. The clinical supervisor (Dr. Rouleau) will evaluate the interventionists' adherence to the BWLT manual and provide feedback as needed (e.g., regarding adherence to the manual, therapeutic/process skills).
Intervention Acceptability
Time Frame: Post-intervention (12 weeks)
Patients will be surveyed to asses satisfaction with the intervention
Secondary Outcomes
- Atrial Fibrillation Symptom Burden(Baseline, 12-weeks)
- Symptoms of Psychological Distress(baseline, 12-weeks)
- AF-related quality of life(baseline, 12-weeks)
- Weight Loss(baseline, 12-weeks)
Investigators
Tavis S. Campbell
Professor
University of Calgary