MOTIVATE AF Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss (MOTIVATE AF)
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Weight Watchers
Slimming world
Leeds 'One You'
NHS Choices
5:2 diet
Individuals own personal plan
Sponsored by
About this trial
This is an interventional supportive care trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants with Atrial Fibrillation attending the clinic.
Arm Description
Outcomes
Primary Outcome Measures
Weight loss of at least 3% at end of year 1
Participant has lost weight at end of year 1. (The weight loss is graded <3%, 3-10%, .10%)
Secondary Outcome Measures
Full Information
NCT ID
NCT04058808
First Posted
August 14, 2019
Last Updated
August 14, 2019
Sponsor
The Leeds Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04058808
Brief Title
MOTIVATE AF Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss
Acronym
MOTIVATE AF
Official Title
Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants with Atrial Fibrillation attending the clinic.
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Weight Watchers
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Slimming world
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Leeds 'One You'
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
NHS Choices
Intervention Description
a free on line programme that is based on restricting calories using the Eat well guide and encouraging physical activity.
Intervention Type
Other
Intervention Name(s)
5:2 diet
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Individuals own personal plan
Intervention Description
the participant will explain in detail their own designed plan and this will be documented on the paper records.
Primary Outcome Measure Information:
Title
Weight loss of at least 3% at end of year 1
Description
Participant has lost weight at end of year 1. (The weight loss is graded <3%, 3-10%, .10%)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MOTIVATE AF Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss
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