Evaluation of a Practice-oriented Recovery Program for Female Endurance Athletes With Relative Energy Deficiency
Condition: Relative Energy Deficiency in Sport
MeSH terms: Relative Energy Deficiency in Sport
Study type: Interventional

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.
    

Intervention name(s): Nutritional behavioral intervention; Nutritional behavioral intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Prevention