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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
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 14, 2019
    Last Updated
    August 14, 2019
    Sponsor
    The Leeds Teaching Hospitals NHS Trust
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    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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