Table 1.

Trial registration data

Data category	Information
Primary registry and trial identifying number	ClinicalTrials.gov NCT05600829
Date of registration in primary registry	01-Nov-2022
Secondary identifying numbers	REB22-0976
Source of monetary or material support	Canadian Institutes of Health Research
Primary sponsor	The University of Calgary
Secondary sponsor	N/A
Contact for public queries	TW [tamara.williamson@uregina.ca] TC [campbet@ucalgary.ca] BV [behmed@ucalgary.ca]
Contact for scientific queries	TW [tamara.williamson@uregina.ca] TC [campbet@ucalgary.ca] BV [behmed@ucalgary.ca]
Public title	A Behavioural Weight Loss Intervention Delivered in Cardiac Rehabilitation for Patients With Atrial Fibrillation and Obesity
Scientific title	A Behavioural Weight Loss Intervention Delivered in Cardiac Rehabilitation for Patients With Atrial Fibrillation and Obesity: The BeWEL IN CR-AF Study
Countries of recruitment	Canada
Health condition(s) or problem(s) studied	Atrial fibrillation (AF) and obesity (BMI ≥ 30 kg/m2)
Intervention(s)	Experimental: Intervention • Patients participate in a traditional 12-week outpatient CR program with added weekly behavioral weight loss sessions (BWLT + CR) Other: Control • Patients participate in a traditional 12-week outpatient CR program (CR-Only)
Key inclusion and exclusion criteria	Ages eligible for study: ≥ 18 years Sexes eligible for study: both Accepts healthy volunteers: no Inclusion criteria: adult patients (≥ 18 years) with symptomatic ECG-documented AF (paroxysmal or persistent type) and obesity Exclusion criteria: 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 BWLT 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
Study type	Interventional Allocation: randomized intervention model Parallel assignment masking: unblinded Primary purpose: tertiary prevention Phase II
Date of first enrolment	11 August, 2023
Target sample size	120
Recruitment status	Recruiting
Primary outcome	Proportion of patients in the intervention group vs. control achieving ≥ 10% body weight change from baseline to 52-week follow-up
Key secondary outcomes	Total weight loss (as a percentage of baseline weight), ECG-documented AF symptoms burden, self-reported AF burden, AF-related quality of life, CR exercise session adherence, weekly step counts, cardiorespiratory fitness from baseline to 52-week follow-up

AF, atrial fibrillation; BMI, body mass index; BWLT, behavioral weight loss treatment; CR, cardiac rehabilitation; ECG, electrocardiogram; GLP-1, glucagon-like peptide 1 receptor agonist