Overnight Fasting After Completion of Therapy: The OnFACT Study

NCT ID: NCT03523377

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-27

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Childhood Cancer Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

prolonged overnight fasting

Intervention Type OTHER

Three phone calls using motivational interviewing, support via SMS text.

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.

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type OTHER

Eat a heart-healthy diet and exercise for at least 30 minutes five days a week

Interventions

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prolonged overnight fasting

Three phone calls using motivational interviewing, support via SMS text.

Intervention Type OTHER

usual care

Eat a heart-healthy diet and exercise for at least 30 minutes five days a week

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rockefeller University

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danielle Friedman, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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18-199

Identifier Type: -

Identifier Source: org_study_id

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