Overnight Fasting After Completion of Therapy
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|ClinicalTrials.gov Identifier: NCT03523377|
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : February 1, 2019
The purpose of this study is to test whether regular not eating for at least 12 hours ("overnight fasting") can improve blood sugar and the health of the GI tract.
There are 2 parts to this study: Part 1 will last for 1-2 weeks and will determine whether the patient can participate in Part 2. If they complete Part 1 they are eligible to participate in Part 2, they will sign a separate consent form for Part 2. Part 2 of this study will last 6 months.
Interim 1 lasts 14 days and begins 10-17 days before Study Visit 1. During Interim 1, participants will complete 1-2 phone calls with study staff. During these calls, 24-hour food recalls will be performed. Staff will use the NCI supported 24-hour recall instrument (Appendix C) to facilitate the recall and enter dietary intake and timing of eating. Nightly fasting duration will be estimated from the 24-hour diet recall by calculating the elapsed hours between the last eating episode at night and the first eating episode the following day. Participants will also be reminded about the fecal collection during these phone calls.
During Interim 2, participants will complete one to 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. Participants will also be prompted to send SMS text messages via the MSK Information Technology secure text messaging system (currently used in the clinical setting for wait time notification).
|Condition or disease||Intervention/treatment||Phase|
|Childhood Cancer Survivors||Other: prolonged overnight fasting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The OnFACT study is a single-arm trial of prolonged overnight fasting among 50 overweight or obese adult survivors of childhood cancer followed in the Memorial Sloan Kettering Adult Long Term Follow Up Program.|
|Masking:||None (Open Label)|
|Official Title:||Overnight Fasting After Completion of Therapy: The OnFACT Study|
|Actual Study Start Date :||April 27, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: prolonged overnight fasting
The purpose of the intervention is to increase the nightly fasting duration to a minimum of 12 hours. Adherence to the intervention will be measured by the proportion of SMS text message-days reflecting 12 or more hours of fasting. The intervention protocol follows an approach using strategies outlined by social cognitive theory that focus on (a) goal setting & (b) building self-efficacy.Interim 1 lasts 14 days & begins 10-17 days before Study Visit 1.
Other: prolonged overnight fasting
Adherence to fasting will be estimated by proportion of the 49 nights (7 weeks) with ≥12 hours of fasting as per text message data from the participant. If the participant neglects to text the fasting duration, that night will be considered not adherent (a conservative adherence estimate).
- measure of glucose metabolism [ Time Frame: after 6 months ]Assess the effect of prolonged overnight fasting on glucose metabolism, measured by glycosylated hemoglobin (HbA1c).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523377
|Contact: Emily Tonorezos, MD, MPHemail@example.com|
|Contact: Danielle Friedman, MD, MS||212-639-7376|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Emily Tonorezos, MD,MPH 646-888-8080|
|Contact: Danielle Friedman, MD, MS 212-639-7376|
|Principal Investigator: Emily Tonorezos, MD, MPH|
|Principal Investigator:||Emily Tonorezos||Memorial Sloan Kettering Cancer Center|