Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2023-03-06
2025-08-04
Brief Summary
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Participants will be randomized into the following two groups:
* Group A: PROFAST intervention for 4 months
* Group B: Healthy Lifestyle Control group for 4 months
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Detailed Description
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The National Cancer Institute of the National Institutes of Health is supporting this research study by providing funding.
This research study is a 4-month randomized trial of prolonged nightly fasting (PROFAST). It is expected that about 40 people will take part in this research study. The total study duration is 4 months.
Participants in the study will be randomized, in equal numbers to either the nightly fasting intervention group or a control group.
* The prolonged nightly fasting (PROFAST) intervention involves gradually working up to a 14-hour fast during the nighttime hours. Participants will be supported by means of calls with a health coach during the first 4 weeks of the study. Participants will also be asked to use a text messaging platform to record their first and last meal of the day, and will receive personalized feedback based on the meal times via the text messaging system. The text messaging system will be used throughout the duration of the study.
* For participants randomized to the control group, an introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living during the 4 months of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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PROLONGED FASTING INTERVENTION
The prolonged nightly fasting (PROFAST) intervention involves gradually working up to a 14-hour fast during the nighttime hours. Participants will be supported by means of calls with a health coach during the first 4 weeks of the study. Participants will also be asked to use a text messaging platform to record their first and last meal of the day, and will receive personalized feedback based on the meal times they record via the text messaging system. The text messaging system will be used throughout the duration of the study.
Prolonged Fasting Intervention
promote a 14-hour fast during the nighttime hours
EDUCATION CONTROL
For participants randomized to the control group, an introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living during the 4 months of the study
EDUCATION CONTROL
introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living
Interventions
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Prolonged Fasting Intervention
promote a 14-hour fast during the nighttime hours
EDUCATION CONTROL
introductory session with a health coach and educational information will be provided. Participants will also receive one email and one text message per week with tips on healthy living
Eligibility Criteria
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Inclusion Criteria
* Documented diagnosis of MGUS or Smoldering MM(SMM) or Smoldering Waldenstrom Macroglobulinemia(WM) via EMR review. \*note: please review case with PI or treating MD if diagnosis is uncertain.
* At least 18 years of age
* Currently fasting for \<14 hours per night, as assessed using 24-hour food recalls
* Owns a cell phone and is comfortable sending and receiving text messages
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Patients diagnosed with another malignancy requiring active therapy
* Clinical diagnosis of diabetes, which may increase the risk of hypoglycemia with a prolonged fast. Note: patients with diabetes may enroll with consent from MD that manages their clinical care.
* Any other condition that, in the investigator's judgment, would contraindicate prolonged nightly fasting or otherwise interfere with participation in the trial, including night shift work, night eating syndrome, taking weight loss medication, or participation in another weight loss program
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Catherine Marinac, PhD
Principal Investigator
Principal Investigators
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Catherine Marinac, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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References
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Lee DJ, O'Donnell EK, Raje N, Panaroni C, Redd R, Ligibel J, Sears DD, Nadeem O, Ghobrial IM, Marinac CR. Design and Rationale of Prolonged Nightly Fasting for Multiple Myeloma Prevention (PROFAST): Protocol for a Randomized Controlled Pilot Trial. JMIR Res Protoc. 2024 Mar 11;13:e51368. doi: 10.2196/51368.
Other Identifiers
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22-071
Identifier Type: -
Identifier Source: org_study_id
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