Overnight Fasting After Completion of Therapy: The OnFACT Study

Memorial Sloan Kettering Cancer Center (MSK) logo

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)

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

Trial contacts and locations

1

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Central trial contact

Danielle Friedman, MD, MS; Chaya Moskowitz, PhD

Data sourced from clinicaltrials.gov

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