Overnight Fasting After Completion of Therapy: The OnFACT Study

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Childhood Cancer Survivors

Treatments: Other: usual care; Other: prolonged overnight fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT03523377

18-199

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

prolonged overnight fasting

Experimental group

Description:

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.

Treatment:

Other: prolonged overnight fasting

usual care

Active Comparator group

Description:

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.

Treatment:

Other: usual care