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MOTIVATE AF Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss (MOTIVATE AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04058808
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Weight Watchers Other: Slimming world Other: Leeds 'One You' Other: NHS Choices Other: 5:2 diet Other: Individuals own personal plan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Participants with Atrial Fibrillation attending the clinic. Other: Weight Watchers
online or in a weekly wellbeing workshop, there is a fee of £12.95 per month, this is a healthy lifestyle programme based on food items having a point attached to them depending on the calorie, fat and sugar content. Each member has a specific number of points per day to use on their meals. The healthier foods have fewer points therefore you can eat more of them.

Other: Slimming world
online or in a weekly class, there is a fee of £5 per week. Free foods can be consumed freely are low fat healthy options, healthy extras (bread/milk/pulses) can be consumed in moderation. Higher fat, higher calorific foods have a number of SYNS attached, each person has a set number of SYNS (sins) per week to use as they wish.

Other: Leeds 'One You'
a free weekly 1 hour class (run in various places across Leeds), a variety of topics are covered, from food labels to the Eat well guide. This eating plan is based on calorie counting.

Other: NHS Choices
a free on line programme that is based on restricting calories using the Eat well guide and encouraging physical activity.

Other: 5:2 diet
5 days of eating normal calories (2000 Female, 2500 Male) and 2 days eating restricted 500 calories (this may be amended depending on the patient).

Other: Individuals own personal plan
the participant will explain in detail their own designed plan and this will be documented on the paper records.

Primary Outcome Measures :
  1. Weight loss of at least 3% at end of year 1 [ Time Frame: 1 year ]
    Participant has lost weight at end of year 1. (The weight loss is graded <3%, 3-10%, .10%)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥18 years
  • BMI>27
  • Symptomatic AF
  • Committed to monthly follow up phone calls and bi annual visits.

Exclusion Criteria:

  • 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

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Responsible Party: The Leeds Teaching Hospitals NHS Trust Identifier: NCT04058808     History of Changes
Other Study ID Numbers: CD19/124451
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Weight Loss
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Body Weight Changes
Body Weight
Signs and Symptoms