NCT04058808

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

August 14, 2019

Last Update Submit

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.

EXPERIMENTAL
Other: Weight WatchersOther: Slimming worldOther: Leeds 'One You'Other: NHS ChoicesOther: 5:2 dietOther: Individuals own personal plan

Interventions

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.

Participants with Atrial Fibrillation attending the clinic.

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.

Participants with Atrial Fibrillation attending the clinic.

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.

Participants with Atrial Fibrillation attending the clinic.

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

Participants with Atrial Fibrillation attending the clinic.

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).

Participants with Atrial Fibrillation attending the clinic.

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

Participants with Atrial Fibrillation attending the clinic.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Atrial Fibrillation

Interventions

Diet

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

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