NCT07460102

Brief Summary

This cluster randomized controlled trial aimed to evaluate the effect of a nutritional education intervention on sports nutrition knowledge, dietary intake, and body composition in adolescent female handball players. Four handball clubs were recruited and randomly allocated in a 1:1 ratio to either an intervention group or a control group. Randomization was performed at the club level to prevent contamination between participants. The intervention consisted of three in-person group educational sessions delivered once per week over a three-week period by a dietitian-nutritionist. Session content was developed based on focus group findings, baseline nutrition knowledge assessment, and results from a previous pilot study. The intervention addressed key sports nutrition topics, including energy requirements, macronutrients, micronutrients, hydration, and healthy eating strategies for athletic performance. The control group continued their usual dietary habits and did not receive any nutritional education during the intervention period. For ethical reasons, the control group received the educational program after study completion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2026

Completed
20 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

9 months

First QC Date

February 18, 2026

Last Update Submit

March 6, 2026

Conditions

Keywords

nutrition education;female athletesnutritional knowledgedietary intakebody composition

Outcome Measures

Primary Outcomes (1)

  • Sports nutrition knowledge

    Change in sports nutrition knowledge score using the NUKYA questionnaire.

    From baseline to post-intervention and three-month follow-up

Secondary Outcomes (10)

  • Adherence to the Mediterranean diet pattern.

    From baseline to three month follow-up.

  • Height

    From baseline to three month follow-up.

  • Weight

    From baseline to three month follow-up.

  • Fat mass

    From baseline to three month follow-up.

  • Muscle mass

    From baseline to three month follow-up.

  • +5 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Receive an educational nutrition program

Other: Nutritional education program

Control Group

NO INTERVENTION

Does not receive any educational nutrition program.

Interventions

The nutritional education intervention consisted of three in-person group sessions delivered by a licensed dietitian-nutritionist, each lasting 30 minutes and delivered once per week.

Intervention Group

Eligibility Criteria

Age12 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female athletes aged 12 to 19 years
  • Minimum of one year of training experience at their club
  • Training at least three days per week for approximately 1.5 hours per session

You may not qualify if:

  • Pre-menarcheal athletes
  • Diagnosis of an eating disorder
  • Presence of a chronic disease requiring a specific dietary plan
  • Pregnancy
  • Lack of proficiency in Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus de l'Alimentació de Torribera, Universitat de Barcelona

Santa Coloma de Gramenet, 08921, Spain

Location

Related Publications (2)

  • Veloso-Pulgar M, Fernandez de Arriba R, Farran-Codina A. Effects of nutrition education programmes designed to improve dietary intake and nutrition knowledge in female athletes: a systematic review. Nutr Res Rev. 2025 Dec;38(2):924-943. doi: 10.1017/S0954422425100152. Epub 2025 Jul 28.

    PMID: 40719032BACKGROUND
  • Veloso-Pulgar M, Farran-Codina A. Effect of a Nutritional Education Intervention on Sports Nutrition Knowledge, Dietary Intake, and Body Composition in Female Athletes: A Pilot Study. Nutrients. 2025 Aug 5;17(15):2560. doi: 10.3390/nu17152560.

    PMID: 40806144BACKGROUND

MeSH Terms

Conditions

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants were not blinded due to the nature of the educational intervention. Outcome assessors and data analysts were blinded to group assignments to reduce bias in data collection and analysis. Investigators and care providers were not blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomization was performed at the club level to prevent contamination between groups. Four women's handball clubs in Catalonia were randomly assigned in a 1:1 ratio, with two clubs allocated to the intervention group and two to the control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Principal Investigator

Study Record Dates

First Submitted

February 18, 2026

First Posted

March 10, 2026

Study Start

February 3, 2025

Primary Completion

October 31, 2025

Study Completion

December 19, 2025

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Shared Documents
STUDY PROTOCOL, ICF

Locations