Evaluation of a Practice-oriented Recovery Program for Female Endurance Athletes With Relative Energy Deficiency

NCT04959565 | Completed

• 1 other identifier: The FUEL program
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 4

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.

Conditions

Relative Energy Deficiency in Sport

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Menstrual bleeding frequency

  16 weeks

• Eating Disorder examination questionnaire (EDE-Q 6.0)

  16 weeks, 6 and 12 months

• Quality of Life (WHOQOL-BREF)

  16 weeks, 6 and 12 months

• Self-perceived knowledge about sports nutrition

  16 weeks, 6 and 12 months

• Sport performance

  16 weeks, 6 and 12 months

Study Arms (3)

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.

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.

Behavioral: Nutritional behavioral intervention

Interventions

Nutritional behavioral intervention BEHAVIORAL

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

16 online lectures in sports nutrition + 8 individual consultations for 16 weeks

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Females as innate sex
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoking
• Non-contraceptive using
• Competitive female endurance athletes
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monica Klungland Torstveit: lead
• Olympiatoppen: collaborator
• Sport Ireland Institute: collaborator
• Technical University of Munich: collaborator
• Linnaeus University: collaborator

Study Sites (4)

Technical University of Munich

Munich, 80333, Germany

Location

Sport Ireland Institue

Dublin, 15, Ireland

Location

University of Agder

Kristiansand, 4630, Norway

Location

Linnaeus University

Kalmar, Sweden

Location

Related Publications (1)

• 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.

  PMID: 38164441 DERIVED

MeSH Terms

Conditions

Relative Energy Deficiency in Sport

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Monica K Tortsveit, Professor

  University of Agder

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 13, 2021
• Study Start: October 8, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); NO (1); SE (1); DE (1)