- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06933888
Assessment of Nutritional Knowledge, Habits, and Eating Behavior in Athletic Women to Evaluate the Possible Impact on Their Menstrual Function
April 10, 2025 updated by: Rossella Nappi, Fondazione IRCCS Policlinico San Matteo di Pavia
The present study aims to investigate the degree of knowledge about nutrition and dietary habits in athletic women through validated questionnaires and to evaluate a possible impact on their menstrual function, including women with a diagnosis of functional hypothalamic amenorrhea (FHA) and women who present with a different menstrual dysfunction (oligomenorrhea or polymenorrhea in absence of organic causes).
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
102
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rossella Nappi, MD
- Phone Number: 0382503325
- Email: r.nappi@smatteo.pv.it
Study Locations
-
-
-
Pavia, Italy, 27100
- Recruiting
- Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita
-
Contact:
- Rossella Nappi, MD
- Phone Number: +390382503325
- Email: r.nappi@smatteo.pv.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Young athletic women referred for menstrual dysfunction of non-organic causes
Description
Inclusion Criteria:
- Female sex
- Age 16-30 years
- Physical activity > 2 days per week
- Informed consent from the patient and/or an authorized legal representative
Exclusion Criteria:
- Menstrual disorders of organic cause (ovarian cysts, uterine fibroids, polyps, etc.)
- Concomitant non-reproductive organic diseases (hypertension, diabetes, etc.)
- Use of psychopharmacological therapies
- Language barrier
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess nutritional knowledge in athletic women with functional hypothalamic amenorrhea
Time Frame: Baseline
|
The outcome will be assessed with a single measurement through a validated questionnaire (General and Sport Nutrition Knowledge [GeSNK]).
More specifically, the proportion of subjects with moderate knowledge (score between 46 and 58) will be evaluated.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of nutritional knowledge in athletic women with menstrual dysfunctions of different nature, comparing women with FHA to those with oligomenorrhea/polymentorrhea in the absence of organic diseases.
Time Frame: Baseline
|
Assessment of nutritional knowledge through GeSNK questionnaire in women with menstrual dysfunction of non-organic cause other than functional hypothalamic amenorrhea
|
Baseline
|
|
Assessment of eating habits in in athletic women with menstrual dysfunctions of different nature, comparing women with FHA to those with oligomenorrhea/polymentorrhea in the absence of organic diseases
Time Frame: Baseline
|
Assessment of eating habits and nutritional intake through a food diary to identify the presence of low energy availability.
|
Baseline
|
|
Evaluation of eating behavior in athletic women with menstrual dysfunctions of different nature, comparing women with FHA to those with oligomenorrhea/polymentorrhea in the absence of organic diseases.
Time Frame: Baseline
|
Assessment of Low Energy Availability in Females questionnaire [LEAF-Q]
|
Baseline
|
|
Evaluation of eating behavior in athletic women with menstrual dysfunctions of different nature, comparing women with FHA to those with oligomenorrhea/polymentorrhea in the absence of organic diseases.
Time Frame: Baseline
|
Assessment of Eating Attitude Test 26 [EAT-26]
|
Baseline
|
|
Evaluation of eating behavior in athletic women with menstrual dysfunctions of different nature, comparing women with FHA to those with oligomenorrhea/polymentorrhea in the absence of organic diseases.
Time Frame: Baseline
|
Assessment of Eating Disorder Inventory -2 [EDI-2]
|
Baseline
|
|
Evaluation of eating behavior in athletic women with menstrual dysfunctions of different nature, comparing women with FHA to those with oligomenorrhea/polymentorrhea in the absence of organic diseases.
Time Frame: Baseline
|
Assessment of ORTO-15 questionnaire
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 13, 2021
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
March 27, 2025
First Submitted That Met QC Criteria
April 10, 2025
First Posted (Actual)
April 18, 2025
Study Record Updates
Last Update Posted (Actual)
April 18, 2025
Last Update Submitted That Met QC Criteria
April 10, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P_6620
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypothalamic Amenorrhea, Functional
-
Peking Union Medical College HospitalGuangdong Provincial Hospital of Traditional Chinese Medicine; Peking University... and other collaboratorsRecruitingFunctional Hypothalamic AmenorrheaChina
-
Karolinska InstitutetKarolinska University Hospital; FoU Centrum, Landstinget SörmlandActive, not recruitingFunctional Hypothalamic AmenorrheaSweden
-
Regeneron PharmaceuticalsRecruitingFunctional Hypothalamic Amenorrhea (FHA)United States
-
Karolinska InstitutetKarolinska University Hospital; FoU Centrum, Landstinget SörmlandNot yet recruitingHypothalamic Amenorrhea, FunctionalSweden
-
Massachusetts General HospitalRecruitingFHA (Functional Hypothalamic Amenorrhea)United States
-
University of VirginiaEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingBone Density | Bone Strength | FHA (Functional Hypothalamic Amenorrhea)United States
-
Mayo ClinicRecruitingHypothalamic Amenorrhea | Hypothalamic Amenorrhea, Functional | Functional Hypogonadotropic HypogonadismUnited States
-
Catholic University of MurciaNot yet recruitingAmenorrhea | Relative Energy Deficiency in Sport | Low Energy Availability | Functional Hypothalamic Amenorrhea (FHA)Spain
-
Catholic University of the Sacred HeartUnknownHypothalamic AmenorrheaItaly
-
Cedars-Sinai Medical CenterCompletedEndothelial Dysfunction | Estrogen Deficiency | Cardiovascular Disease (CVD) | Functional Hypothalamic AmenorrheaUnited States