Behavioural Weight Loss Treatment for Patients with Atrial Fibrillation and Obesity in Cardiac Rehabilitation

NCT05230823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-12-05

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

CR with added BWLT

12 week outpatient cardiac rehab (CR) program consisting of twice-weekly supervised exercise and risk factor modification (e.g. smoking cessation, support with medication). Concurrently, the patients will attend a weekly behavioural weight loss treatment (BWLT). Weekly goal-setting facilitated by the interventionist will focus on behavioural changes in nutrition and moderate calorie reduction while also emphasizing physical activity consistent with an individualized CR exercise prescription. Patients will track caloric intake, weekly exercise, weekly weight, and success/challenges with other health goals (e.g., challenging negative thoughts, body image, mindful eating, etc.) using a daily health diary. ASPIRE-AF will be delivered virtually to small groups (8-12 patients) by senior PhD students with advanced training in cognitive-behavioural therapy and motivational communication principles.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Tavis S Campbell, PhD · University of Calgary

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2023-01-15
Completion
2023-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05230823 on ClinicalTrials.gov