Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)
- Conditions
- ObesityDiabetes Mellitus, Type 2Morbid ObesityAtrial Fibrillation
- Interventions
- Behavioral: Intermittent Fasting
- Registration Number
- NCT04090840
- Lead Sponsor
- University of Chicago
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Age ≥18
- BMI≥ 30
- Ongoing evaluation and management of cardiac arrhythmias
- Pregnant or nursing
- Eating disorder or history of eating disorders (self-report)
- Diabetic mellitus type 1 or insulin requiring type 2 diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intermittent Fasting Intermittent Fasting 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.
- Primary Outcome Measures
Name Time Method Weight loss 6 months Patients will be weighed weekly for the first month and than have weight checks in clinic monthly
- Secondary Outcome Measures
Name Time Method Body Mass Index Monthly until 6 months calculated from height and weight measured in clinic
Waist Circumference Monthly until 6 months measured by research specialist at umbilicus
Blood Pressure Monthly until 6 months measured in clinic by nursing staff
Quality of Life Assessment 6 months SF36 Questionnaire to be filled out by patient
Hemoglobin a1c 6 months Blood test in patients with diabetes mellitus
Trial Locations
- Locations (1)
The University of Chicago
🇺🇸Chicago, Illinois, United States