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

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

Study Locations

      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita
        • Contact:

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

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

Subscribe