跳至主要内容
临床试验/NCT04058808
NCT04058808Unknown不适用

Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss

The Leeds Teaching Hospitals NHS Trust0 个研究点目标入组 100 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Weight loss of at least 3% at end of year 1

研究概览

简要总结

This study is designed to look at the impact that support and motivation has on patients with Atrial Fibrillation's ability to lose weight and maintain this. We believe that weight loss has a positive impact on the reduction of symptoms of atrial fibrillation and can decrease the likelihood of the arrhythmia returning following cardio version.

This study is designed for patients who have a diagnosis of Atrial Fibrillation and have a Body Mass Index greater than 27.

In the study, we plan to provide support and motivation to patients with atrial fibrillation to encourage weight loss. There are several weight loss strategies available to follow. Information will be provided about each strategy to encourage informed choices. If the initial strategy chosen is not working, this can be change to a more suitable one as required. Follow up will be by telephone at 2 and 4 weeks then every month thereafter where you will be asked your weight and to clarify the weight loss strategy you are following. You will be seen at 6 and 12 months where you will have an ECG, BP check and your weight measured. A final telephone assessment will take place at 24 months.

We hope that the research will in the future help patients with Atrial Fibrillation manage and maintain their weight loss to improve their symptoms and prevent recurrence of the arrhythmia. The results of this study could potentially change practice in our centre by providing more structured weight loss clinics for patients with Atrial Fibrillation

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Symptomatic AF
  • Committed to monthly follow up phone calls and bi annual visits.

排除标准

  • Any co morbidity that would reduce life expectancy to within the year.
  • Unable to commit to follow up.
  • Patients recruited to weight loss studies that are on going

研究组 & 干预措施

Participants with Atrial Fibrillation attending the clinic.

Experimental

干预措施: Individuals own personal plan (Other)

Participants with Atrial Fibrillation attending the clinic.

Experimental

干预措施: 5:2 diet (Other)

Participants with Atrial Fibrillation attending the clinic.

Experimental

干预措施: Weight Watchers (Other)

Participants with Atrial Fibrillation attending the clinic.

Experimental

干预措施: Slimming world (Other)

Participants with Atrial Fibrillation attending the clinic.

Experimental

干预措施: Leeds 'One You' (Other)

Participants with Atrial Fibrillation attending the clinic.

Experimental

干预措施: NHS Choices (Other)

结局指标

主要结局

Weight loss of at least 3% at end of year 1

时间窗: 1 year

Participant has lost weight at end of year 1. (The weight loss is graded \<3%, 3-10%, .10%)

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

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