Clinical trial NCT04959565: Evaluation of a Practice-oriented Recovery Program for Female Endurance Athletes With Relative Energy Deficiency
Official title: Evaluation of a Practice-oriented Recovery Program for Female Endurance Athletes With Relative Energy Deficiency - The FUEL Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relative Energy Deficiency in Sport
Lead sponsor: University of Agder
Sponsor class: OTHER
Collaborators: name: Olympiatoppen
name: Sport Ireland Institute
name: Technical University of Munich
name: Linnaeus University
First posted: 2021-07-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will receive video lectures + individual consultations, while the other intervention group will receive video lectures only.

A control group was planned for Spring 2020 but do to the COVID-19 pandemic the investigators had to cancel the reqruitment of the control group.

Now the investigators plan a new recruitment of a control group for Authum 2021.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Non-smoking
* Non-contraceptive using
* Competitive female endurance athletes
* 18-35 years of age
* training minimum 5 times a week
* Athletes with LEAF-Q score ≥ 8 and EDE-Q score \< 2.5 from part 1 will be invited to participate in the 16 week FUEL intervention

Exclusion Criteria:

* Pregnancy or planned pregnancy
* Risk of eating disorders defined as an EDE-Q score ≥ 2.5
* chronic diseases (e.g. diabetes, crohn's disease, thyroid dysfunction)
* Use of any medication that may disturb hormonal balance

Primary outcomes:
measure: Low Energy Availability in Females Questionnaire score
timeFrame: 16 weeks
Secondary outcomes:
measure: Menstrual bleeding frequency
timeFrame: 16 weeks
measure: Eating Disorder examination questionnaire (EDE-Q 6.0)
timeFrame: 16 weeks, 6 and 12 months
measure: Quality of Life (WHOQOL-BREF)
timeFrame: 16 weeks, 6 and 12 months
measure: Self-perceived knowledge about sports nutrition
timeFrame: 16 weeks, 6 and 12 months
measure: Sport performance
timeFrame: 16 weeks, 6 and 12 months
measure: Participant evaluation
timeFrame: 1 week after end intervention
measure: Sports nutrition related behavior
timeFrame: 16 weeks, 6 and 12 months
measure: Experiences with participation in the FUEL project
timeFrame: Approximately four weeks after end intervention
measure: Exercise addiction
timeFrame: 16 weeks, 6 and 12 months
measure: Eating Disorder Inventory (EDI) subscale score Drive for Thinness (DT)
timeFrame: 16 weeks, 6 and 12 months
measure: Knowledge about sports nutrition for female endurance athletes
timeFrame: 16 weeks
measure: Appetite
timeFrame: 16 weeks
measure: Readiness to train
timeFrame: 16 weeks
measure: Sleep quality
timeFrame: 16 weeks
measure: Sleep quantity
timeFrame: 16 weeks
measure: Carbohydrate availability
timeFrame: 16 weeks
measure: Nutrients
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technical University of Munich
city: Dublin
country: Ireland
facility: Sport Ireland Institue
city: Kristiansand
country: Norway
facility: University of Agder
city: Kalmar
country: Sweden
facility: Linnaeus University
Study officials:
affiliation: University of Agder
name: Monica K Tortsveit, Professor
role: STUDY_DIRECTOR
References: