Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)

Study Overview
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Brief Summary
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BACKGROUND AND RATIONALE Two out of three Americans are overweight and obesity is associated with hypertension, sleep apnea, atrial fibrillation. Metabolic syndrome with centripetal obesity is also a precursor to insulin resistance and the development of Type II diabetes mellitus. While multiple strategies for weight reduction are often recommended in physician visits, calculating calories and energy expenditure is often inconvenient and does not promote compliance. Intermittent fasting, or time-restricted eating, is a methods to limit caloric intake by fasting for 16 hours to promote ketosis and suppress insulin secretion. Weight loss and reduction in body fat has been observed with brief periods of intervention as time-restricted eating results in reduction in overall caloric intake. Prospective feasibility studies and randomized comparative trials with intermittent fasting are lacking. The investigators recommend caloric restriction in all of our patients that suffer from arrhythmias and BMI >30. However, they have not systematically measured compliance and the efficacy of lifestyle interventions. Lifestyle counseling and weight loss has been shown to decrease the progression and burden of symptomatic atrial fibrillation. Intermittent fasting can result in consistent reductions in body fat and weight without specific lifestyle counseling. The aim of the present observation cohort study is to assess the feasibility of recommending intermittent fasting in an arrhythmia clinic with regard to compliance and efficacy. The investigators hypothesize that compliance and adherence to a 16/8 intermittent fasting regimen will be >25% and result in weight loss, compared to the 6 month trend prior to the intervention. This pilot study will serve as the basis to power the first randomized trial comparing intermittent fasting with other types of dietary counseling for arrhythmia outcomes. OBJECTIVES To prospectively assess compliance to prescribed intermittent fasting, measured by adherence and change in weight at 6 months.

Official Title
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Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)

Conditions
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Obesity, Morbid Obesity, Diabetes Mellitus, Type 2, Atrial Fibrillation

Intervention / Treatment
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* Behavioral: Intermittent Fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 BMI≥ 30 Ongoing evaluation and management of cardiac arrhythmias Exclusion Criteria: Pregnant or nursing Eating disorder or history of eating disorders (self-report) Diabetic mellitus type 1 or insulin requiring type 2 diabetes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective observation study of lifestyle intervention with intermittent fasting (time-restricted eating) of 16 hours every day.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent Fasting<br>Patients will follow intermittent fasting for 16 hours with time restricted eating during an 8 hour window. The subjects are also advised to minimize sugar intake to <15g per serving. | Behavioral: Intermittent Fasting<br>* Time restricted eating for 8 hours per day, with 16 hour fast. During the daily fast, patients are encouraged to drink water, black coffee, or green tea without sugar, cream, milk, or sweeteners.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Patients will be weighed weekly for the first month and than have weight checks in clinic monthly | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | calculated from height and weight measured in clinic | Monthly until 6 months | 
| Waist Circumference | measured by research specialist at umbilicus | Monthly until 6 months | 
| Blood Pressure | measured in clinic by nursing staff | Monthly until 6 months | 
| Quality of Life Assessment | SF36 Questionnaire to be filled out by patient | 6 months | 
| Hemoglobin a1c | Blood test in patients with diabetes mellitus | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, fasting, diet