Promotion of Wellbeing in Women Athletes (NCT03064230) | Clinical Trial Compass
CompletedNot Applicable
Promotion of Wellbeing in Women Athletes
200 participantsStarted 2016-01-01
Plain-language summary
The Female Athlete Triad is a medical condition often observed in physically active girls and women, and involves 3 components: (1) low energy availability with or without disordered eating, (2) menstrual dysfunction, and (3) low bone mineral density. An early intervention is essential to prevent its progression to serious endpoints including clinical eating disorders, amenorrhea, and osteoporosis that can affect the quality of life of these patients and even compromise the athletic performance.
All patients, aged between 14 and 40 years, who met the inclusion and exclusion criteria, were prospectively enrolled in this observational study and were divided into two groups: Athletes agonists (Experimental Group or Group A) and women who do not perform agonistic sports (Control Group or Group B). In both groups of patients, the investigators administered two types of questionnaires: a standardized quality of Life questionnaire, validated in Italian (SF-12) and a screening questionnaire recommended by the Female Athlete Triad Expert Panel.
Who can participate
Age range
14 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. age between 14 and 40 years;
. absence of malignancies;
. informed consent obtained from the patient;
. no previous surgical, chemotherapic and/or radiotherapic treatments.
Exclusion criteria
. recent traumas;
. recent surgeries;
. oncologic history;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of life through a validated in Italian (SF-12) and a screening questionnaire recommended by the Female Athlete Triad Expert Panel.
Timeframe: day 1 at time of the visit. no follow/up