NCT07461766

Brief Summary

To identify changes in eating habits and symptoms of premenstrual tension in adolescent athletes before and after a nutritional education program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

March 3, 2026

Last Update Submit

March 6, 2026

Conditions

Nutritional AssessmentsAdolescent Athletic PerformancePremenstrual Syndrome

Keywords

adolescent athletesnutritional educationbody compositionpremenstrual symptoms

Outcome Measures

Primary Outcomes (1)

  • Nutritional Knowledge Questionnaire

    The questionnaire called "Nutritional Knowledge Questionnaire," has a maximum score of 53 points, considering 1 point for each correctly answered question and zero points for unanswered or incorrectly answered questions. The questionnaire does not have a minimum score. The questionnaire consists of 2 parts. The first part consists of multiple-choice questions about nutritional knowledge, and the second part consists of questions about dietary beliefs in sports nutrition.

    immediately after the end of the intervention

Study Arms (1)

single arm

EXPERIMENTAL

Nutritional education program

Behavioral: nutritional education

Interventions

nutritional educationBEHAVIORAL

Monthly nutritional education workshops, over five months, covering topics relevant to sports nutrition.

single arm

Eligibility Criteria

Age15 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale adolescents athletes
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescentes athletes between 15 and 17 years old
  • adolescents in their reproductive phase (menacme)
  • participants in a field soccer sports project

You may not qualify if:

  • comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo - Gynecology Department

São Paulo, 04023-900, Brazil

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zuszsanna J Di Bella, MD PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Researcher

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 10, 2026

Study Start

February 1, 2025

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)