Evaluation of a Practice-oriented Recovery Program for Female Endurance Athletes With Relative Energy Deficiency

Relative Energy Deficiency in Sport Clinical Trial

Official title: Evaluation of a Practice-oriented Recovery Program for Female Endurance Athletes With Relative Energy Deficiency - The FUEL Programme

Status Completed

Clinical Trial Summary

The aim of this study is to develop, implement and evaluate the effects of a 16 week practice orientated sports nutrition education and counselling program aiming to improve energy availability and to investigate the effects on physiological and psychological health, sports nutrition knowledge, and athletic performance in well-trained female endurance athletes with risk of RED-S. The FUEL (in Norwegian: Forstå Utholdenhetsidretts Ernæring - et Læringsprogram; in English: Food and nUtrition for Endurance athletes - a Learning program) recovery program consists of virtual lectures with central themes within sports nutrition in addition to individual consultations.

Clinical Trial Description

The current project is a reversed version of the original project which included a wide range of laboratory measurements, but due to the COVID-19 pandemic the investigators had to change the test protocol to a "corona friendly" version without any physical contact between the investigators and the participants. The cancellation of laboratory tests affects many key aspects and outcomes of the project's initial plan, including the initial primary outcome energy availability which require accurate measurement of fat free mass. This ungoing project is therefore marked by the drastic decisions that had to be made immediately before recruitment considering the corona pandemic.

The investigators aim to develop, implement and evaluate a 16-week practice orientated online sports nutrition education and counselling program for female endurance athletes at risk of RED-S. The study will be evaluated in terms of changes in self-reported physiological and psychological health parameters as well as the participants' reported experiences.

A systematic evaluation of the FUEL program will be provided based on the RE-AIM framework.

The following research questions will be addressed:

Can the FUEL recovery program...

• reduce LEAF-Q score in female endurance athletes with risk of RED-S?

• improve reproductive function in female endurance athletes with MD?

• reduce EDE-Q and DT score in female endurance athletes with risk of RED-S?

• improve quality of life in female endurance athletes with risk of RED-S?

• improve sports nutrition knowledge in female endurance athletes with risk of RED-S?

• improve performance in female endurance athletes with risk of RED-S?

• improve sports nutrition habits in female endurance athletes with risk of RED-S?

• improve carbohydrat availability in female endurance athletes with risk of RED-S?

• reduce EAI score in female endurance athletes with risk of RED-S?

• recover menstrual function in female endurance athletes with MD assessed 6- or 12-months post intervention?

Additional research questions are:

• How do the participants experience to be part of the FUEL recovery program?

• How do the nutritional counselors experience the feasibility of the FUEL recovery program?

• How feasible is the FUEL program based on the RE-AIM framework?

Participants will be included in their athleic off-season and data will be conducted at baseline and at week 17 (immediately after the 4-month intervention). For the qualitative part of the FUEL project (interviews about participant experiences), data will be conducted approximately 1 month after end intervention.

An information letter will be available at the FUEL homepage (www.uia.no/fuel), and a link to the part 1 (screening) questionnaire will be available about two months before baseline testing (part 2). For the screening phase (part 1) volunteers will be asked to complete the Eating Disorder Examination Questionnaire (EDE-Q), the LEAF-Q, and the Exercise Addiction Inventory (EAI) besides additional background information (e.g. educational level). Athletes with a LEAF-Q score ≥8, will be invited to participate in the intervention (part 3) initiating with a baseline data collection week (part 2) and ending with a post intervention data collection week (part 4). Athletes with a global EDE-Q score ≥ 2.5 will be excluded due to high risk of EDs and thus high risk of non-compliance to this intervention. Part 2 and 4 includes a seven-day prospective weighed diet and activity record, an online questionnaire with questions concerning athletic performance, sports nutrition habits, self-efficiacy, drive for thinness, and quality of life as well as a welcome telephone call, including twenty statements about sports nutrition for endurance athletes.

Follow-up will be conducted 6 and 12 months post intervention.

Randomization of participants within the same geographical research site is considered unreasonable due to the high risk of imitation of intervention. Therefore, the investigators plan a waitlist control group starting with a 16-week period, including testing and questionnaires without the FUEL recovery program followed by the 16-week FUEL intervention.

The virtual lectures will be based on sports nutrition recommendations for female endurance athletes according to international peer reviewed consensus statements. The participants will get access to an online platform where the FUEL recovery program will be initiated with session 1 the week after baseline testing and the athletes are requested to follow the lectures lead by highly experienced sports dietitians for the respective weeks. Every other week for 16 weeks (8 sessions in total) participants will be offered individual nutrition counselling by highly experienced sports nutritionists in each country, based on Motivational Interviewing, the individual's environmental and biological prerequisites, and the Transtheoretical Model, focusing on the individual's readiness to act on a new healthier behavior.

In order to evaluate the FUEL recovery program based on the RE-AIM framework, an evaluation questionnaire as well as qualitative interviews will be performed post intervention for athletes and their nutrition counsellors. ;

Related Conditions & MeSH terms

• Relative Energy Deficiency in Sport

• NCT number: NCT04959565
• Study type: Interventional
• Source: University of Agder
• Status: Completed
• Phase: N/A
• Start date: October 8, 2020
• Completion date: June 1, 2022