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Behavioral Weight Loss Intervention + Cardiac Rehab for Atrial Fibrillation and Obesity (BeWEL IN CR-AF Trial)
N/A
Recruiting
Led By Tavis Campbell, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic paroxysmal or persistent atrial fibrillation or atrial flutter
Have a sedentary lifestyle (not currently meeting basic physical activity targets of ≥150 minutes/week)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks, 24 weeks, 52 weeks
Awards & highlights
BeWEL IN CR-AF Trial Summary
This trial will assess if adding weight-loss therapy to cardiac rehab helps people with AF and obesity reduce AF symptoms.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the trial itself may not directly cause side effects, participants engaging in new physical activities could experience muscle soreness, fatigue, or other exercise-related discomforts. Psychological strategies might also bring stress until fully integrated into one's routine.
BeWEL IN CR-AF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience sudden or ongoing irregular heartbeats.
Select...
I do not exercise for at least 150 minutes a week.
Select...
My BMI is 30 or higher, classifying me as obese.
BeWEL IN CR-AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks, 24 weeks, 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks, 24 weeks, 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients achieving ≥10% body weight change
Secondary outcome measures
AF Burden
AF Symptom Burden
AF-related Quality of Life
+5 moreBeWEL IN CR-AF Trial Design
2Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Patients participate in a traditional 12-week outpatient CR program with added weekly behavioural weight loss classes.
Group II: ControlExperimental Treatment1 Intervention
Patients participate in a traditional 12-week outpatient CR program.
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,034 Total Patients Enrolled
14 Trials studying Obesity
1,036 Patients Enrolled for Obesity
Alberta Health servicesOTHER
158 Previous Clinical Trials
649,546 Total Patients Enrolled
3 Trials studying Obesity
979 Patients Enrolled for Obesity
University of British ColumbiaOTHER
1,418 Previous Clinical Trials
2,466,998 Total Patients Enrolled
12 Trials studying Obesity
1,879 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am scheduled for a procedure to correct my irregular heartbeat.I am currently on GLP-1 receptor agonist medication.I experience sudden or ongoing irregular heartbeats.I had or will have weight-loss surgery within a year of joining the study.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.My BMI is 30 or higher, classifying me as obese.I am currently in a weight loss program.You completed a clinical trial within the past year.I am open to trying a weight loss program.I have had atrial fibrillation for 3 years or more, or it is permanent.My heart disease is not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers presently being recruited for this trial?
"Clinicaltrials.gov indicates that this medical research project is presently not enrolling participants, after the post date of June 15th 2023 and final update on May 8th 2023. Fortunately, there are still a significant number of clinical trials actively recruiting - 1,588 in total - at present."
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