Overnight Fasting After Completion of Therapy: The OnFACT Study

The purpose of this study is to test whether regularly not eating for at least 14 hours overnight ("intermittent fasting") is feasible and can improve blood sugar.

Study Overview

• Status: Recruiting
• Conditions: Childhood Cancer Survivors
• Intervention / Treatment: Other: prolonged overnight fasting; Other: usual care

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Friedman, MD, MS; Phone Number: 212-639-7376; Email: friedmad@mskcc.org
• Study Contact Backup: Name: Chaya Moskowitz, PhD; Phone Number: 646-888-8232

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Danielle Friedman, MD, MS; Phone Number: 212-639-7376
      • Principal Investigator: Danielle Friedman, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Body mass index is ≥ 18.5 kg/m^2
• History of treatment for cancer or related illness diagnosed at ≤ 25 years old
• Off cytotoxic therapy for primary cancer ≥ 2 years
• Not receiving cytotoxic therapy (chemotherapy, external beam radiation therapy) at the time of study enrollment
• History of radiation to the chest, abdomen or total body
• Current age ≥18 years
• English-speaking
• Personal phone with SMS text messaging capability
• Willingness to wear an mHealth device, such as a FitBit, for two 7-day periods
• Able to perform all study requirements

Exclusion Criteria:

• Use of any antidiabetic, weight loss, or appetite control medication
• Use of any other medication that could impact dietary intake, such as prednisone
• Currently fasts 12 hours or more by self-report
• Unable to fast due to medical reason such as pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prolonged overnight fasting; Participants randomized to the fasting arm will be instructed on how to use the SMS texting app to indicate the beginning and end of the nightly fast. In the first 2-4 weeks following the first overnight fast, intervention participants will complete three phone calls with study staff trained in motivational interviewing. These calls will be used to reinforce the prolonged overnight fasting instructions, identify barriers to prolonged overnight fasting, and support successes where they have occurred.	Other: prolonged overnight fasting; Three phone calls using motivational interviewing, support via SMS text.
Active Comparator: usual care; Participants randomized to the usual care arm will be instructed to eat a heart-healthy diet and exercise for at least 30 minutes five days a week, which is usual counseling in our clinics.	Other: usual care; Eat a heart-healthy diet and exercise for at least 30 minutes five days a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation completion	Proportion of registered participants who successfully complete the 6-month intervention	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure of glucose metabolism	Assess the effect of prolonged overnight fasting on glucose metabolism, measured by glycosylated hemoglobin (HbA1c).	6 months

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Rockefeller University
• Investigators: Principal Investigator: Danielle Friedman, MD, MS, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2018
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Fasting; 18-199
• Other Study ID Numbers: 18-199

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No