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

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ClinicalTrials.gov Identifier: NCT04090840
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE September 11, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
Weight loss [ Time Frame: 6 months ]
Patients will be weighed weekly for the first month and than have weight checks in clinic monthly
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • Body Mass Index [ Time Frame: Monthly until 6 months ]
    calculated from height and weight measured in clinic
  • Waist Circumference [ Time Frame: Monthly until 6 months ]
    measured by research specialist at umbilicus
  • Blood Pressure [ Time Frame: Monthly until 6 months ]
    measured in clinic by nursing staff
  • Quality of Life Assessment [ Time Frame: 6 months ]
    SF36 Questionnaire to be filled out by patient
  • Hemoglobin a1c [ Time Frame: 6 months ]
    Blood test in patients with diabetes mellitus
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)
Official Title  ICMJE Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective observation study of lifestyle intervention with intermittent fasting (time-restricted eating) of 16 hours every day.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Morbid Obesity
  • Diabetes Mellitus, Type 2
  • Atrial Fibrillation
Intervention  ICMJE Behavioral: Intermittent Fasting
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.
Study Arms  ICMJE Experimental: 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.
Intervention: Behavioral: Intermittent Fasting
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
100
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tiffany Hart 7737020535 thart@medicine.bsd.uchicago.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090840
Other Study ID Numbers  ICMJE IRB19-0879
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roderick Tung, MD University of Chicago
PRS Account University of Chicago
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP