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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04959565
• Other study ID #: The FUEL program
• Status: Completed
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: December 2023
• Source: University of Agder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Relative Energy Deficiency in Sport

Intervention

Behavioral:
• Nutritional behavioral intervention
The participants will get access to an online platform where the FUEL recovery program will be initiated with session 1 immediately 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 (one intervention group) 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
• Nutritional behavioral intervention
The participants will get access to an online platform where the FUEL recovery program will be initiated with session 1 immediately after baseline testing and the athletes are requested to follow the lectures lead by highly experienced sports dietitians for the respective weeks.

Locations

Country	Name	City	State
Germany	Technical University of Munich	Munich
Ireland	Sport Ireland Institue	Dublin
Norway	University of Agder	Kristiansand
Sweden	Linnaeus University	Kalmar

Sponsors (5)

Lead Sponsor	Collaborator
Monica Klungland Torstveit	Linnaeus University, Olympiatoppen, Sport Ireland Institute, Technical University of Munich

Countries where clinical trial is conducted

Germany,  Ireland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low Energy Availability in Females Questionnaire score	In this reversed project description, the primary outcome will be change in LEAF-Q score from pre- to post intervention.; Low Energy Availability in Females Questionnaire (LEAF-Q) assess menstrual funktion, gatsrointestinal funktion and injuries and have been widely used to detect female athletes at risk for RED-S. The questinnaire have been validated in Scandinavian female elite endurance athletes. A score of 8 or more is assessed as a sign of low energy availability.; Based on an initial analysis during the recruitment phase with an expected improvement in LEAF-Q score of 3 and Type I and Type II error of 5% and 20% respectively, the power calculation suggest 28 subjects in each group. To account for dropouts, the investigators aim for 35 participants in each group.	16 weeks
Secondary	Menstrual bleeding frequency	Self-reported using BESTR	16 weeks
Secondary	Eating Disorder examination questionnaire (EDE-Q 6.0)	The Eating Disorder Examination Questionnaire (EDE-Q) is a 28-item self-reported questionnaire adapted from the semi-structured interview Eating Disorder Examination. Each question can be answered on a scale from 0 to 6. Higher score means higher risk of eating disorder.; It is designed to assess the range and severity of features associated with a diagnosis of eating disorder using 4 subscales (Restraint, Eating Concern, Shape Concern and Weight Concern) and a global score.	16 weeks, 6 and 12 months
Secondary	Quality of Life (WHOQOL-BREF)	World Health Organization Quality of Life-BREF (WHOQOL-BREF). Each answer will be converted to a point from 1-5 by the scienists, where higher score equals better quality of life.	16 weeks, 6 and 12 months
Secondary	Self-perceived knowledge about sports nutrition	Five self-constructed questions which is rank on a scale from 1 to 10. Higher score means higher self-perceived knowledge about sports nutrition.	16 weeks, 6 and 12 months
Secondary	Sport performance	Ten self-constructed questions in relation to the RED-S model concerning self-experienced athletic performance the last 4 weeks. Each question will be answered on a scale from 1-10 with alternating "good" or "bad" performance for high and low values, respectively.	16 weeks, 6 and 12 months
Secondary	Participant evaluation	An online questionnaire containing 21 questions regarding the participants' evaluation of the FUEL intervention. The questionnaire contains both open and closed questions. Questions with answers on a scale from 1 to 10 will be presented as mean +/- SD, while others will be presented as a percentage or in text (for open questions).	1 week after end intervention
Secondary	Sports nutrition related behavior	Eight self-constructed questions regarding sports nutrition behavior the last 4 weeks. All questions are closed with different frequency categories. These will be presented as a percentage.	16 weeks, 6 and 12 months
Secondary	Experiences with participation in the FUEL project	Qualitative interviews with participants and their nutrition supervisors. An interview guide will be followed for the participants and the supervisors, respectively. An investigator who has not been a part of the development or the implementation of the FUEL intervention itself, will be conducting the interviews.	Approximately four weeks after end intervention
Secondary	Exercise addiction	The exercise addiction inventory (EAI) is a short screening tool consisting of six questions based upon the six components of addiction. Each question can be answered on a scale from 1-5. Higher score means higher risk of exercise addiction.	16 weeks, 6 and 12 months
Secondary	Eating Disorder Inventory (EDI) subscale score Drive for Thinness (DT)	EDI DT score have previously been found as a proxy indicator of energy deficiency in exercising women. The DT scale consist of seven questions about attitudes and behaviors concerning eating, weight, and shape. Each question has six possible answers which corresponds to a score from 0 to 4. Higher score means higher drive for thinness.	16 weeks, 6 and 12 months
Secondary	Knowledge about sports nutrition for female endurance athletes	A telephone interview where the investigator reads out 20 claims about sports nutrition. The participant has the possibility to answer "true", "false" or "unsure". A higher percentage of correct answer means better knowledge about sports nutrition.	16 weeks
Secondary	Appetite	Every day during the baseline testing week, during the intervention and during the post intervention week, participants are encouraged to rank their level of appetite in BESTR training diary on a scale from 1 to 10, 1 corresponding to no appetite and 10 corresponding to a great degree of appetite.	16 weeks
Secondary	Readiness to train	Every day during the baseline testing week, during the intervention and during the post intervention week, participants are encouraged to rank their level of readiness to train in BESTR training diary on a scale from 1 to 10, 1 corresponding to not ready at all and 10 corresponding to a great degree of readiness to train.	16 weeks
Secondary	Sleep quality	Every day during the baseline testing week, during the intervention and during the post intervention week, participants are encouraged to rank their sleep quality in BESTR training diary on a scale from 1 to 10, 1 corresponding to low and 10 corresponding to a high sleep quality.	16 weeks
Secondary	Sleep quantity	Every day during the baseline testing week, during the intervention and during the post intervention week, participants are encouraged their daily sleep in hours and minutes in BESTR training diary.	16 weeks
Secondary	Carbohydrate availability	Participants are ask to register all foods and beverages during the baseline registration week and the post intervention week. Carbohydrate availability will be expressed in g/kg body weight and compared to current sports nutrition guidelines.	16 weeks
Secondary	Nutrients	Participants are ask to register all foods and beverages during the baseline registration week and the post intervention week. Nutrients will be analyzed in Dietist Net for Norwegian and Swedish athletes, Nutritics for Irish athletes, and EBISpro for German athletes.	16 weeks

External Links

•   webpage for study description and infomation letter