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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)
Must not have
Currently scheduled to receive catheter ablation in AF
Currently taking GLP-1 receptor agonist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks, 24 weeks, 52 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience sudden or ongoing irregular heartbeats.
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I do not exercise for at least 150 minutes a week.
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My BMI is 30 or higher, classifying me as obese.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for a procedure to correct my irregular heartbeat.
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I am currently on GLP-1 receptor agonist medication.
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I had or will have weight-loss surgery within a year of joining the study.
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I am currently in a weight loss program.
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I have had atrial fibrillation for 3 years or more, or it is permanent.
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My heart disease is not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks, 24 weeks, 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks, 24 weeks, 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients achieving ≥10% body weight change
Secondary study objectives
AF Burden
AF Symptom Burden
AF-related Quality of Life
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
811 Previous Clinical Trials
892,695 Total Patients Enrolled
14 Trials studying Obesity
1,036 Patients Enrolled for Obesity
Alberta Health servicesOTHER
163 Previous Clinical Trials
652,538 Total Patients Enrolled
3 Trials studying Obesity
979 Patients Enrolled for Obesity
University of British ColumbiaOTHER
1,481 Previous Clinical Trials
2,494,796 Total Patients Enrolled
13 Trials studying Obesity
1,899 Patients Enrolled for Obesity
Tavis Campbell, PhDPrincipal InvestigatorUniversity of Calgary

Media Library

BWLT Clinical Trial Eligibility Overview. Trial Name: NCT05600829 — N/A
Obesity Research Study Groups: Intervention, Control
Obesity Clinical Trial 2023: BWLT Highlights & Side Effects. Trial Name: NCT05600829 — N/A
BWLT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05600829 — N/A
~17 spots leftby Mar 2025
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