Effect of a Nutritional Education Intervention on Sports Nutrition Knowledge, Dietary Intake, and Body Composition in Female Athletes: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Sports nutrition knowledge
研究概览
简要总结
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.
详细描述
2. Materials and Methods 2.1. Study Design This study was conducted as part of the Assessment of Training in Healthy Habits and Nutritional Education for Adolescent Athletes (ATHENEA) project, which received ethical approval from the Bioethics Committee of the University of Barcelona (initial protocol: IRB00003099, June 30, 2023; modified protocol: IRB00003099, October 14, 2025). A parallel-group cluster randomized controlled trial (RCT) in sports club settings was implemented to evaluate a three-week nutritional education intervention targeting adolescent female handball players in Catalonia, Spain.
Prior to the development of the main study, a pilot project was conducted between September 2023 and October 2024, which allowed for the refinement of the intervention protocol and the optimization of both the intervention procedures and the data collection strategies.
The study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki. All participants, as well as their parents and coaches, received a comprehensive description of the study, both orally and in writing. Participation was voluntary, and written informed consent was obtained from all participants or, in the case of minors under 16 years of age, from their parents or legal guardians.
2.2. Randomization Randomization was performed at the club level to prevent potential contamination between groups and ensure the internal validity of the study. Using the official registry of women's handball clubs in Catalonia, each club was assigned a unique sequential numerical code, and selection was carried out randomly. Initial contact followed this numerical order and was established via email and telephone, culminating in an in-person meeting with club representatives and/or technical directors to explain the study objectives and formally invite participation. If a club declined the invitation, the next club on the sequential list was contacted until a total of four clubs agreed to participate. The four clubs were randomized to the study groups in a 1:1 ratio, allocating two clubs to the intervention group (IG) and two clubs to the control group (CG).
While individual allocation was not concealed, outcome assessors and data analysts were blinded to group assignments. Participants, however, could not be blinded due to the inherent nature of the educational intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Pre-menarcheal athletes
- •Diagnosis of an eating disorder
- •Presence of a chronic disease requiring a specific dietary plan
- •Pregnancy
- •Lack of proficiency in Spanish
研究组 & 干预措施
Intervention Group
Receive an educational nutrition program
干预措施: Nutritional education program (Other)
Control Group
Does not receive any educational nutrition program.
结局指标
主要结局
Sports nutrition knowledge
时间窗: From baseline to post-intervention and three-month follow-up
Change in sports nutrition knowledge score using the NUKYA questionnaire.
次要结局
- 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.)
- Fat-free mass(From baseline to three month follow-up.)
- Food intake(From baseline to three-month follow-up)
- Energy intake(From baseline to three month follow-up.)
- Macronutrients(From baseline to three month follow-up.)
- Micronutrients(From baseline to three month follow-up.)
研究者
Andreu Farran-Codina
Professor and Principal Investigator
University of Barcelona