How old do I have to be to participate in the study?
All participants must be between 18 and 35 years of age.
Where do I have to go for all of the appointments during the study?
All of the study appointments (including visits with medical doctors, dieticians, and clinical psychologists) will take place at the Women’s Exercise and Bone Health Lab at the University of Toronto located at 55 Harbord St. Toronto, Ont.
If I volunteer as a participant, how long will I be involved in the study?
As a subject participating in the study, you will be involved with the study for just over a year or about 12-14 months.
How often will I have to come into the lab as a volunteer in the study?
Volunteers with irregular or absent menstrual cycles will be asked to come to the Women’s Exercise and Bone Health lab for testing, on average, twice a month. Volunteers with regular menstrual cycles will be asked to come to the lab for testing, on average, once a month.
How long are the visits to the lab?
Each time you are required to visit the lab, it could take anywhere from 15 to 180 minutes. The laboratory staff will let you know before each appointment how long the visit is expected to take.
How many hours of participation does this study involve?
If you are in one of the irregular or absent menstrual groups, your participation will involve approximately 170.5 hours over the course of the 14 month study period. If you are in the regular menstrual group, your participation will involve approximately 117.5 hours over the course of the 14 month study period.
How many hours are required to be in the lab?
If you are in one of the irregular or absent menstrual groups, your participation will involve being at the laboratory for 62 hours. If you are in the regular menstrual group, your participation will involve being at the laboratory for 47 hours.
Will I be compensated for my time?
Yes, you will be compensated for your time. Please contact us for further information.
What if I need to withdraw from the study?
Your participation in this study is voluntary and you may withdraw from this study at any time by notifying the investigator. Your refusal to participate in this research study or decision to withdraw at any time will in no way affect your academic standing, evaluation, grading, or program in any way. Your withdrawal from this study or your refusal to participate will in no way affect your care or access to medical services.
What happens if I just stopped talking oral contraceptives (birth control pills) can I still participate in the study?
To be eligible to participate in the study you must not be talking any form of hormonal therapy (including oral contraceptives) for at least 6 months.
What happens if I start taking oral contraceptives during the study?
We will have to exclude you from further participation in the study because the research study pertains to the menstrual cycle and hormones
What happens if I get pregnant during the study?
If you become pregnant during the study you will be notified immediately and because the research study pertains to the menstrual cycle and hormones, we will have to exclude you from further participation in the study.
How often is urine collected during the study?
If you are in one of the irregular or absent menstrual groups, you will be asked to collect a urine sample every morning for the entire study period until post study week one. If you are in the regular menstrual group, you will be asked to collect a urine sample every morning for a total of four menstrual cycles (baseline month and months 4, 8, and 12).
What if I miss a day of urine collection?
If you miss a day of urine collection let the laboratory personnel know immediately. Please recognize that monetary compensation will be based on continued compliance and completion of the study protocol; therefore, compensation may be altered if you do not complete the required procedures.
Does it matter what time of day the urine is collected?
Yes, you will be asked to collect all urine samples when you first get up in the morning.
How do I store the urine until I bring it to the lab?
You will be asked to store the small urine cups in your refrigerator until they are brought into the lab.
Do I still have to collect urine if I go on vacation?
Yes, if you leave town you are still expected to collect urine. We will provide supplies to help you store urine in a travel situation.
How often do I have to get my blood taken during the study?
Your blood will be taken eight times over a period of 12 to 14 months. Your blood will be taken once during the screening part of the study and once during the baseline month of the study. For all groups of subjects, blood will then be collected monthly (weeks 1, 5, 9) until month (week 9), and then every three months (weeks 21, 33, and week one post study) for the remainder of the study.
When you take blood, how much do you take?
During the first blood draw we will take no more than 4 tablespoons (80ml total) of blood. Then during the remaining blood draws approximately 6 tablespoons (100ml total) of blood will be collected.
Who takes my blood?
Only trained laboratory personnel will be drawing blood.
What is a DXA?
DXA stands for dual-energy x-ray absorptiometry and tests your bone mineral density. This tells us how strong your bones are. During the study we will determine the bone mineral density of your hip, lower back, and of your total body.
How much exercise testing is involved in this study?
One exercise test will be performed during baseline to determine your fitness level. This test will be completed during week of the baseline period and take about 30 minutes to complete.
Can I choose which study group I am in?
No, you will be randomly assigned to one of three volunteer groups based on your menstrual cycle.
Will to get the results of the study?
Yes, you will be informed of the results of all tests performed on you, and of the results of the study as a whole.
How do I volunteer to be a subject in the study?
If you are interested is volunteering for the “REFUEL” Active Women’s Study II you can contact us using one of the following methods: 1) call the Active Women’s Study II Hotline at the University of Toronto at 416-946-8707, 2) e-mail us at active.womenstudy@utoronto.ca, or 3) fill out the Online Refuel Questionnaire (See Procedures for Volunteering)