NCT06116097

Brief Summary

This study investigates the effects of a series of nutrition education sessions conducted by a registered dietitian on energy availability, various anthropometric measurements, eating attitudes, and sports nutrition knowledge in young female endurance athletes aged 15-18 years (football, basketball, volleyball) who engage in training for more than 10 hours per week (n=83).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

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

April 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2020

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

October 30, 2023

Last Update Submit

March 12, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Energy Availability

    Energy availability (EA) is described as the amount of energy left over and available for proper organism functions after the energy used for exercise is subtracted from the calories taken in the diet, by American College of Sports Medicine. It is shown that the young athletes often fail to follow the recommended dietary guidelines for their sport and activity level. Therefore that poses risk for low energy availability (LEA) EA below 30 kcal/kg FFM was considered to be low EA, EA between 30-45 kcal/kg was considered to be reduced and EA\>45 kcal/kg was considered to be optimal.

    6 months

  • Low Energy Availability Questionnaire (LEAF-Q)

    The 25-item LEAF-Q was used to assess the risk of LEA. The LEAF-Q has been validated in female athletes aged 18-39 training ≥5 times/week, with findings producing an acceptable sensitivity (78%) and specificity (90%) to classify current energy availability\[28\]. Consistent with the original validation study players completed a paper version of the LEAF-Q to ensure validity and reliability were maintained. Scoring was based on the original validation study, with those who scored ≤7 being classified as 'not at risk' of LEA, and those who scored ≥8 being classified as 'at risk' of LEA\[28\].

    6 months

Secondary Outcomes (8)

  • Sports nutrition knowledge questionnaire (SNKQ)

    6 months

  • Eating Atittude Test (EAT-26)

    6 months

  • Dietary intake

    6 months

  • Exercise Energy Expenditure

    6 months

  • Fat-free mass

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Nutrition education intervention group

EXPERIMENTAL

Nutrition education was comprimised of 6 physical face to face 60 minutes sessions which was given every week in a school class. Each session was consisted of a different subject including energy metabolism in sport, energy balance, nutrition before and after training, low energy availability, macro and micronutrients, hydration and supplements. Participants also got written information as a printed booklet in order to be able to take notes under sessions and review after the sessions.

Behavioral: Nutrition education

Control group

NO INTERVENTION

Control group has not taken any nutrition education but has been filled all of the questionnaires, acitivity logs and food diaries.

Interventions

Fifty participants took 6 physical nutrition education lectures and the other group (n=33) didn't have any nutrition education. Nutrition education was comprimised of 6 physical face to face 60 minutes sessions which was given every week in a school class. Each session was consisted of a different subject including energy metabolism in sport, energy balance, nutrition before and after training, low energy availability, macro and micronutrients, hydration and supplements. Participants also got written information as a printed booklet in order to be able to take notes under sessions and review after the sessions.

Nutrition education intervention group

Eligibility Criteria

Age14 Years - 18 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Non-contraceptive using Competitive female endurance athletes 14-18 years of age training minimum 6 hours a week not taking a break from sports for more than 3 months due to injury

You may not qualify if:

  • Pregnancy or planned pregnancy chronic diseases (e.g. diabetes, crohn's disease, thyroid dysfunction) Use of any medication that may disturb hormonal balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltalimanı Research and Training Hospital

Istanbul, Sarıyer, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Relative Energy Deficiency in Sport

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Cansu T Akman, MS

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: A total of 83 adolescent female elite athletes from 3 different sport clubs (football n=34, basketball n=16 and volleyball n=33) between 15 and 18 years(mean 17.2 ± 2.0) were included in the study.They were divided into either the intervention or the control groupby simple randomization. Fortyfem participants took 6 physical nutrition education lectures and the other group (n=38) didn't have any nutrition education. All of them filled the LEAF-Q (Low energy availability in athletes questionnaire),EAT-26(Eating Attitude Test)and SNKQ (Sports Nutrition Knowledge Questionnaire).Energy and nutrient intakes were assessed based on 3-day food records. Activity logs were analysed to measure exercise energy expenditure. All of the tests have been repeated after 6 months. Nutrition education was comprised of 6 physical 60 minutes sessions given every week in a school class. Each session was consisted of a different subject. Participants got written information as a printed booklet.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mrs.

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 3, 2023

Study Start

April 1, 2019

Primary Completion

September 1, 2019

Study Completion

March 28, 2020

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations