Overnight Fasting After Completion of Therapy: The OnFACT Study

Study Overview
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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.

Official Title
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Overnight Fasting After Completion of Therapy: The OnFACT Study

Conditions
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Childhood Cancer Survivors

Intervention / Treatment
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* Other: prolonged overnight fasting
* Other: usual care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The OnFACT study is a pilot randomized controlled trial of prolonged overnight fasting among adult survivors of childhood cancer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prolonged overnight fasting<br>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<br>* Three phone calls using motivational interviewing, support via SMS text.<br>|
| Active Comparator: usual care<br>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<br>* Eat a heart-healthy diet and exercise for at least 30 minutes five days a week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation completion | Proportion of registered participants who successfully complete the 6-month intervention | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of glucose metabolism | Assess the effect of prolonged overnight fasting on glucose metabolism, measured by glycosylated hemoglobin (HbA1c). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fasting, 18-199