Evaluation of a Practice-oriented Recovery Program for Female Endurance Athletes With Relative Energy Deficiency
NCT ID: NCT04959565
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2020-10-08
2022-06-01
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
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.
PREVENTION
NONE
Study Groups
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16 online lectures in sports nutrition + 8 individual consultations for 16 weeks
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.
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
Control
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.
No interventions assigned to this group
16 online lectures in sports nutrition for 16 weeks
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
FEMALE
Yes
Sponsors
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Olympiatoppen
UNKNOWN
Sport Ireland Institute
UNKNOWN
Technical University of Munich
OTHER
Linnaeus University
OTHER
Monica Klungland Torstveit
OTHER
Responsible Party
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Monica Klungland Torstveit
Professor
Principal Investigators
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Monica K Tortsveit, Professor
Role: STUDY_DIRECTOR
University of Agder
Locations
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Technical University of Munich
Munich, , Germany
Sport Ireland Institue
Dublin, , Ireland
University of Agder
Kristiansand, , Norway
Linnaeus University
Kalmar, , Sweden
Countries
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References
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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.
Other Identifiers
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The FUEL program
Identifier Type: -
Identifier Source: org_study_id