Thank you for your interest in this research study.  The purpose of this study is to learn more about the effects of an intermittent fasting weight loss program on weight loss, diet adherence, and change in physical activity in adults age 18-65 with stage 1-3 breast cancer  This study will also collect feedback to refine the weight loss program for a larger future research study.  If you join this research study, the intervention lasts for 6 months and your participation will last for ~9 months. 

 

You will be asked to use intermittent fasting to reduce your calorie intake.  You will be asked to perform a modified fast three days per week for the duration of the 6-month intervention.  On the 3 modified fast days per week, you will restrict calories significantly (eat only 500 calories per day).  On the 4 non-fast days per week, you will be asked to eat a sensible, healthy diet but will not have to restrict calorie intake.

 

You will attend regular weight loss group meetings for 6 months led by a registered dietician.  Group meetings are held on a weekday evening virtually via Zoom and last 60-90 minutes.  The meetings are held weekly for the first 3 months and then twice a month during months 4-6. 

 

You will be enrolled in the BfitBwell oncology exercise program and asked to gradually progress your physical activity level to 150-300 minutes per week of moderate intensity exercise.  You will attend BfitBwell exercise sessions both in-person at the Anschutz Health and Wellness Center Fitness Center and virtually through the True Coach app.  Training sessions will be 45-60 minutes in length and will focus on aerobic, resistance, and flexibility exercises.

 

During the 6-month intervention, you will also undergo periodic assessments of your body weight, body composition, laboratory values, and diet and exercise behaviors (2-3 study assessment visits, occurring approximately every 3 months for a total of 6-9 visits).  After 3 months, you will also be asked to participate in a focus group to give your feedback on the intervention.

 

To see if you are likely to qualify to be in the study, we would like to ask you some eligibility questions, which will include questions about your health history, including questions about your mental health and drug and alcohol use.  It should take about 15-20 minutes to complete these screening questions.  Some of the questions may make you uncomfortable; you do not have to answer any question that you would not like to answer, but without answers to these questions, you will not be eligible to participate in the study.  We will collect your name and contact information, but will use an identification code (rather than your name) on the form used to record your answers.  If you do not enroll in this study, we will keep the information collected during this pre-screening secure.  We are also required to give you the number of COMIRB (303) 724-1055, the Ethics Board that oversees our research in case you have any questions or concerns..

 

If you have any questions about the screening survey or problems with the survey please contact the study team at time2bwell@cuanschutz.edu.

 

If you have no questions, please begin answering the questions below.

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