Overnight Fasting After Completion of Therapy: The OnFACT Study

Not Applicable

Recruiting

• Conditions: Childhood Cancer Survivors
• Interventions: Other: usual care; Other: prolonged overnight fasting

• Registration Number: NCT03523377
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-27
• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-05-01
• Study First Posted: 2018-05-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
usual care	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.
prolonged overnight fasting	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.

Primary Outcome Measures

Name	Time	Method
Participation completion	6 months	Proportion of registered participants who successfully complete the 6-month intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States