MOTIVATE AF Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss
MOTIVATE AF
Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss
1 other identifier
interventional
100
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable atrial-fibrillation
Started Sep 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2019
CompletedFirst Posted
Study publicly available on registry
August 16, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedAugust 16, 2019
August 1, 2019
2 years
August 14, 2019
August 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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%)
1 year
Study Arms (1)
Participants with Atrial Fibrillation attending the clinic.
EXPERIMENTALInterventions
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.
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.
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.
a free on line programme that is based on restricting calories using the Eat well guide and encouraging physical activity.
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).
the participant will explain in detail their own designed plan and this will be documented on the paper records.
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- BMI\>27
- Symptomatic AF
- Committed to monthly follow up phone calls and bi annual visits.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2019
First Posted
August 16, 2019
Study Start
September 1, 2019
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
August 16, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share