Overnight Fasting After Completion of Therapy: The OnFACT Study

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03523377

Collaborator

Rockefeller University (Other)

Enrollment

Location

Arms

71.2

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Cancer Survivors	Other: prolonged overnight fasting Other: usual care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

The OnFACT study is a pilot randomized controlled trial of prolonged overnight fasting among adult survivors of childhood cancer.The OnFACT study is a pilot randomized controlled trial of prolonged overnight fasting among adult survivors of childhood cancer.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Overnight Fasting After Completion of Therapy: The OnFACT Study

Actual Study Start Date :

Apr 27, 2018

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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 randomization, 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

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 randomization, 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

Outcome Measures

Primary Outcome Measures

Participation completion [6 months]
Proportion of registered participants who successfully complete the 6-month intervention

Secondary Outcome Measures

measure of glucose metabolism [6 months]
Assess the effect of prolonged overnight fasting on glucose metabolism, measured by glycosylated hemoglobin (HbA1c).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 of all cancer therapy for ≥ 2 years (excluding treatment for non-invasive or superficial cancers)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center
Rockefeller University

Investigators

Principal Investigator: Danielle Friedman, MD, MS, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center

Publications

None provided.

Responsible Party:

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT03523377

Other Study ID Numbers:

18-199

First Posted:

May 14, 2018

Last Update Posted:

May 20, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Memorial Sloan Kettering Cancer Center

Fasting

18-199

Study Results

No Results Posted as of May 20, 2022