Relative Energy Deficiency in SportNCT04959565
Evaluation of a Practice-oriented Recovery Program for Female Endurance Athletes With Relative Energy Deficiency
A study testing Nutritional behavioral intervention in people with Relative Energy Deficiency in Sport, run by Monica Klungland Torstveit at 4 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Relative Energy Deficiency in Sport
- What is being tested?
- Nutritional behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 8 Oct 2020to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Evaluation of a Practice-oriented Recovery Program for Female Endurance Athletes With Relative Energy Deficiency - The FUEL Programme
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.
Read the 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.
- Conditions
- Relative Energy Deficiency in Sport
- Being tested
- Nutritional behavioral intervention
- Medical subject headings
- Relative Energy Deficiency in Sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional behavioral interventionBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 16 online lectures in sports nutrition + 8 individual consultations for 16 weeks | Experimental | Non-smoking, non-contraceptive using, competitive female endurance athletes, 18-35 years of age, training a minimum of five times per week will be recruited through social media and endurance sports clubs (running, cycling, orienteering, triathlon, biathlon, and cross-country skiing) in Norway, Sweden, Germany, and Ireland.
Athletes with a LEAF-Q score ≥8 + EDE-Q score < 2.5 who meets the other inclusion criteria will be invited for further participation.
The lectures are designed for female endurance athletes at risk of RED-S. The participants will get access to a new lecture every week during the intervention. Receives: Behavioral: Nutritional behavioral intervention |
| Control | No intervention | Non-smoking, non-contraceptive using, competitive female endurance athletes, 18-35 years of age, training a minimum of five times per week will be recruited through social media and endurance sports clubs (running, cycling, orienteering, triathlon, biathlon, and cross-country skiing). Athletes with a LEAF-Q score ≥8 + EDE-Q score < 2.5 who meets the other inclusion criteria will be invited for further participation. |
| 16 online lectures in sports nutrition for 16 weeks | Experimental | Non-smoking, non-contraceptive using, competitive female endurance athletes, 18-35 years of age, training a minimum of five times per week will be recruited through social media and endurance sports clubs (running, cycling, orienteering, triathlon, biathlon, and cross-country skiing) in Norway, Sweden, Germany, and Ireland.
Athletes with a LEAF-Q score ≥8 + EDE-Q score < 2.5 who meets the other inclusion criteria will be invited for further participation.
The lectures are designed for female endurance athletes at risk of RED-S. The participants will get access to a new lecture every week during the intervention. Receives: Behavioral: Nutritional behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (17)
Menstrual bleeding frequency
Self-reported using BESTR
Measured: 16 weeks
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.
Measured: 16 weeks, 6 and 12 months
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.
Measured: 16 weeks, 6 and 12 months
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.
Measured: 16 weeks, 6 and 12 months
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.
Measured: 16 weeks, 6 and 12 months
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).
Measured: 1 week after end intervention
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.
Measured: 16 weeks, 6 and 12 months
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.
Measured: Approximately four weeks after end intervention
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.
Measured: 16 weeks, 6 and 12 months
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.
Measured: 16 weeks, 6 and 12 months
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.
Measured: 16 weeks
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.
Measured: 16 weeks
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.
Measured: 16 weeks
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.
Measured: 16 weeks
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.
Measured: 16 weeks
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.
Measured: 16 weeks
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start8 Oct 2020
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relative Energy Deficiency in SportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monica Klungland Torstveit
- Sponsor type
- University, hospital or other
- Collaborators
- Olympiatoppen, Sport Ireland Institute, Technical University of Munich, Linnaeus University
- Responsible party
- Sponsor-investigator, Monica Klungland Torstveit, University of Agder
- Investigators
- Monica K Tortsveit, Professor, Study director, University of Agder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959565
- Sponsor's protocol ID
- The FUEL program
- Status last verified
- Dec 2023
- First submitted
- 23 Jun 2021
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fahrenholtz IL, Melin AK, Garthe I, Wasserfurth P, Ivarsson A, Hollekim-Strand SM, Koehler K, Logue D, Madigan S, Grafnings M, Torstveit MK. Short-term effects and long-term changes of FUEL-a digital sports nutrition intervention on REDs related symptoms in female athletes. Front Sports Act Living. 2023 Dec 18;5:1254210. doi: 10.3389/fspor.2023.1254210. eCollection 2023.
PubMed 38164441
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Practice-oriented Recovery Program for Female Endurance Athletes With Relative Energy Deficiency - The FUEL Programme
- ClinicalTrials.gov ID
- NCT04959565
- Acronym / sponsor ID
- The FUEL program
- Conditions
- Relative Energy Deficiency in Sport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Monica Klungland TorstveitUniversity, hospital or other
- Collaborators
- Olympiatoppen, Sport Ireland Institute, Technical University of Munich, Linnaeus University
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 16 online lectures in sports nutrition + 8 individual consultations for 16 weeks | Experimental | Behavioral: Nutritional behavioral interventionNon-smoking, non-contraceptive using, competitive female endurance athletes, 18-35 years of age, training a minimum of five times per week will be recruited through social media and endurance sports clubs (running, cycling, orienteering, triathlon, biathlon, and cross-country skiing) in Norway, Sweden, Germany, and Ireland. Athletes with a LEAF-Q score ≥8 + EDE-Q score < 2.5 who meets the other inclusion criteria will be invited for further participation. The lectures are designed for female endurance athletes at risk of RED-S. The participants will get access to a new lecture every week during the intervention. |
| Control | No intervention | –Non-smoking, non-contraceptive using, competitive female endurance athletes, 18-35 years of age, training a minimum of five times per week will be recruited through social media and endurance sports clubs (running, cycling, orienteering, triathlon, biathlon, and cross-country skiing). Athletes with a LEAF-Q score ≥8 + EDE-Q score < 2.5 who meets the other inclusion criteria will be invited for further participation. |
| 16 online lectures in sports nutrition for 16 weeks | Experimental | Behavioral: Nutritional behavioral interventionNon-smoking, non-contraceptive using, competitive female endurance athletes, 18-35 years of age, training a minimum of five times per week will be recruited through social media and endurance sports clubs (running, cycling, orienteering, triathlon, biathlon, and cross-country skiing) in Norway, Sweden, Germany, and Ireland. Athletes with a LEAF-Q score ≥8 + EDE-Q score < 2.5 who meets the other inclusion criteria will be invited for further participation. The lectures are designed for female endurance athletes at risk of RED-S. The participants will get access to a new lecture every week during the intervention. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoking
- Non-contraceptive using
- Competitive female endurance athletes
- 18-35 years of age
- training minimum 5 times a week
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional behavioral interventionThe 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 | Behavioural | 16 online lectures in sports nutrition + 8 individual consultations for 16 weeks |
| Nutritional behavioral interventionThe 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. | Behavioural | 16 online lectures in sports nutrition for 16 weeks |
Primary outcome
Low Energy Availability in Females Questionnaire score
Time frame: 16 weeks
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.
17 secondary outcomes
Menstrual bleeding frequency
Time frame: 16 weeks
Eating Disorder examination questionnaire (EDE-Q 6.0)
Time frame: 16 weeks, 6 and 12 months
Quality of Life (WHOQOL-BREF)
Time frame: 16 weeks, 6 and 12 months
Self-perceived knowledge about sports nutrition
Time frame: 16 weeks, 6 and 12 months
Sport performance
Time frame: 16 weeks, 6 and 12 months
Participant evaluation
Time frame: 1 week after end intervention
Sports nutrition related behavior
Time frame: 16 weeks, 6 and 12 months
Experiences with participation in the FUEL project
Time frame: Approximately four weeks after end intervention
Exercise addiction
Time frame: 16 weeks, 6 and 12 months
Eating Disorder Inventory (EDI) subscale score Drive for Thinness (DT)
Time frame: 16 weeks, 6 and 12 months
Knowledge about sports nutrition for female endurance athletes
Time frame: 16 weeks
Appetite
Time frame: 16 weeks
Readiness to train
Time frame: 16 weeks
Sleep quality
Time frame: 16 weeks
Sleep quantity
Time frame: 16 weeks
Carbohydrate availability
Time frame: 16 weeks
Nutrients
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 38164441Fahrenholtz IL, Melin AK, Garthe I, Wasserfurth P, Ivarsson A, Hollekim-Strand SM, Koehler K, Logue D, Madigan S, Grafnings M, Torstveit MK. Short-term effects and long-term changes of FUEL-a digital sports nutrition intervention on REDs related symptoms in female athletes. Front Sports Act Living. 2023 Dec 18;5:1254210. doi: 10.3389/fspor.2023.1254210. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica K Tortsveit, Professor study director
University of Agder
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional behavioral intervention in people with Relative Energy Deficiency in Sport, run by Monica Klungland Torstveit at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Ireland, Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Energy Availability in Females Questionnaire score (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.