Overnight Fasting After Completion of Therapy: The OnFACT Study

NCT03523377 | Active Not Recruiting

• 1 other identifier: 18-199
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cancer Survivors

Keywords

Fasting; 18-199

Outcome Measures

Primary Outcomes (1)

• Participation completion

  Proportion of registered participants who successfully complete the 6-month intervention

  6 months

Secondary Outcomes (1)

• measure of glucose metabolism

  6 months

Study Arms (2)

prolonged overnight fasting

EXPERIMENTAL

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.

Other: prolonged overnight fasting

usual care

ACTIVE COMPARATOR

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

Interventions

prolonged overnight fasting OTHER

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

prolonged overnight fasting

usual care OTHER

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

usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Rockefeller University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Danielle Friedman, MD, MS

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: April 27, 2018
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (1)