A Behavioural Weight Loss Intervention Delivered in Cardiac Rehabilitation for Patients With Atrial Fibrillation and Obesity: The BeWEL IN CR-AF Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Proportion of patients achieving ≥10% body weight change
研究概览
简要总结
One-in-four Canadians will be diagnosed with an abnormal heart rhythm called atrial fibrillation (AF) in their lifetime. This is expected to double by 2050, owing to an aging population and increased age- and health behaviour-associated AF risk factors (e.g., poor cardiorespiratory fitness, Type II diabetes, hypertension, and obesity). AF is associated with an increased risk of severe health outcomes including stroke, heart failure, dementia, and death. 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 randomized controlled trial will assess whether the combination of an AF-specific 'small changes' BWLT and traditional CR results in a greater proportion of patients with AF and obesity achieving ≥ 10% body weight loss compared to patients who receive standard care (traditional CR alone). Traditional CR consists of participating in exercise sessions, supervised by health professionals, twice per week for 12 weeks. In addition to traditional CR, patients that are randomized to receive BWLT will attend 12 weekly online group therapy classes to learn strategies from psychology to help encourage weight loss. The investigators will collect data pertaining to weight, AF burden, physical activity, and disease-specific and generic patient-reported outcomes. This information will determine if taking CR+BWLT helps patients with weight loss and AF symptoms. Further, it will help efforts to provide effective treatment to patients with AF to help participants lose weight and reduce or eliminate AF symptoms.
详细描述
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.
Given the high prevalence of obesity among individuals with AF, and its detrimental effect on AF burden and outcomes, there is a critical need for interventions that can support weight-loss-promoting behaviours and can be integrated into routine clinical care for AF. CR programs are available in all major Canadian cities and have a proven track-record of achieving clinically-relevant improvements in important AF risk factors including hypertension, lipid profile, and exercise capacity. Therefore, CR represents an ideal setting to promote risk factor management for patients with AF. Yet, because traditional CR does not produce meaningful weight loss there is a clear gap in the ability of current CR programming to meet the needs of a growing population of individuals with AF and obesity. The addition of a novel BWLT component to CR is needed to bridge this gap and provide the appropriate treatment regimen of comprehensive risk factor management, exercise, and weight loss to achieve optimal AF outcomes.
The primary aim is to: Assess whether the combination of an AF-specific 'small changes' BWLT and traditional CR results in a greater proportion of patients with AF and obesity achieving ≥ 10% body weight loss compared to patients who receive standard care (traditional CR alone).
The secondary aims of the proposed study are to evaluate the impact of BWLT+CR on: 1) mean % weight loss of controls vs. intervention group; 2) AF burden; 3) self-reported AF symptom burden; 4) disease-specific and generic patient-reported outcome measures (e.g., AF- and health-related quality-of-life [HRQoL]; psychological distress); and 5) exercise volume measured in weekly steps.
Hypotheses:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of age ≥18 years
- •Symptomatic paroxysmal or persistent atrial fibrillation or atrial flutter
- •Classified as obese (BMI ≥30 kg/m2)
- •Have a sedentary lifestyle (not currently meeting basic physical activity targets of ≥150 minutes/week)
- •Ability to speak and write in English
- •Willingness to be referred to a behavioural weight loss treatment (BWLT)
- •At least one of the following: obstructive sleep apnea, diabetes, hypertension, heart failure, dyslipidemia, CAD, peripheral artery, or cerebrovascular disease.
排除标准
- •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 behavioural weight loss 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.
结局指标
主要结局
Proportion of patients achieving ≥10% body weight change
时间窗: Baseline, 52 weeks
Assessed by dividing the number of kilograms at 52 weeks by the initial (T1) kg and multiplying by 100%.
次要结局
- Symptoms of Psychological Distress(Baseline, 12 weeks, 24 weeks)
- AF Burden(12 weeks, 24 weeks, 52 weeks)
- CR Exercise Session Adherence(12 weeks)
- AF-related Quality of Life(Baseline, 12 weeks, 24 weeks)
- Total Weight Loss(Baseline, 12 weeks, 24 weeks, 52 weeks)
- Cardiorespiratory Fitness(Baseline, 12 weeks, 24 weeks, 52 weeks)
- AF Symptom Burden(Baseline, 12 weeks, 24 weeks)
- Weekly Step Counts(12 weeks, 24 weeks)
研究者
Tavis S. Campbell
Professor
University of Calgary