NCT05709678

Brief Summary

Athletes in low energy availability (LEA) are at increased risk of developing the Relative Energy Deficiency in Sports (RED-S) syndrome (Mountjoy et al., 2018). LEA is a mismatch between dietary energy intake and exercise energy expenditure, leaving inadequate energy to support physiological functions, and the RED-S syndrome increases the risk of impaired health and performance (Drew et al., 2018, Sesbreno et al., 2022a, under review; Sesbreno et al., 2022b, in preparation; \& VanHeest et al., 2014). Although athletes with eating disorders are at high risk, many more may be vulnerable due to uninformed practices for weight loss and/or failure to match energy intake to energy demands for exercise (Wells et al., 2020). Despite efforts to better detect athletes in LEA/RED-S;there is no research on the effectiveness of dietary interventions to influence energy intake in international elite/world-class athletes tomitigate risk of LEA (De Souza et al., 2021; Elliott-Sale et al., 2018; Heikura et al., 2021; Melin et al., 2014; Stellingwerf et al., 2021;Stenqvist et al., 2021 \& Rogers et al., 2021). Therefore, it is important to investigate dietary interventions to influence eating habits to improve energy availability in elite athletes. Energy deficit associated with LEA in elite athletes may be accompanied by insufficient carbohydrate intake for training demands (Burke et al., 2011; Heikura et al., 2017; Sesbreno et al., 2021). Unfortunately, there is a paucity of information on the influence of sport nutrition education interventions on dietary intake in elite international (tier 4) and world-class (tier 5) athletes (McKay et al., 2022). However, recent findings suggest an association between nutrition knowledge and energy/carbohydrate availability in young female endurance athletes (Kettunen et al., 2021). This finding may offer a cost effective approach to lower the risk of LEA since education programs have shown to improve nutrition knowledge in athletes (Tam et al., 2019). However, an increase in nutrition knowledge may not always lead to a parallel increase in energy/carbohydrate intake (Heikkila et al., 2019). Indeed, the influence of nutrition education programs on improving dietary intake in athletes is reportedly equivocal (Boidin et al., 2021). However, the differences in intervention design with lack of guidelines on standardized and/or validated methods to assess sport nutrition knowledge and eating habits in elite athletes have made comparisons difficult for generalized interpretation. Fortunately, the new arrival of the Platform to Evaluate Athlete Knowledge of Sports Nutrition Questionnaire (PEAK-NQ) and the Athlete Diet Index (ADI) offer validated methods for assessing sport nutrition knowledge and eating habits in elite athletes (Capling et al., 2021 and Tam et al., 2021). Nevertheless, it is also important to appreciate that nutrition knowledge is not the sole influencing factors to athletes' dietary habits; and recognizing additional factors affecting athletes' decisions around nutrition is critical. A multitude of factors influence food choices in elite athletes (Thurecht et al., 2019). It ranges from sensory appeal, emotional influences, influence of others, weight control, performance among others (Thurecht et al, 2020). Interestingly, a moderate intercorrelation between nutritional attributes of the food and weight control, performance as well as food values and beliefs were reported (Thurecht et al., 2021). In fact, restraint eating behaviour have been associated with LEA, body weight and physique morphology (Jurov et al., 2021; Sesbreno et al., 2021; Sesbreno et al., 2022c in preparation; Sesbreno et al., 2022d, in preparation \& Viner et al., 2015). Clearly, multiple factors influence dietary habits, and therefore, it is important to consider how education interventions are developed to influence dietary outcomes in elite athletes. The Capability, Opportunity, Motivation - Behaviour (COM-B) model describes the importance of influencing 3-sources of behaviour to consistently alter habits (Michie et al., 2011). This was reiterated by sport nutritionists who characterized enablers and barriers to nutrition adherence in high performance sports (Bentley et al., 2019). In a case study, dietary interventions that targeted all 3-source behaviours was associated with improvements in dietary intake, including energy availability as an elite rugby player prepared for his 1st professional season (Costello et al., 2018). Therefore, a sport nutrition education program that accounts for all source behaviours may be necessary to improve eating habits intake to lower the risk of LEA/RED-S in elite international and world-class athletes during the competitive season. Overall Aim: Investigate whether elite athletes' nutrition knowledge and dietary intake can improve through an education intervention to lower the risk of low energy availability.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

January 24, 2023

Last Update Submit

November 30, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Knowledge

    PEAK-NQ questionnaire

    3 weeks

  • Change in carbohydrate intake

    Food intake record

    3 weeks

Secondary Outcomes (1)

  • Change in food frequency

    3 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

Group Education (General nutrition and sport nutrition)

Other: Enhanced Education

Treatment

ACTIVE COMPARATOR

Group Education (General nutrition and sport nutrition with athlete testimonials on impacts of RED-S on health)

Other: Standard Education

Interventions

Sport nutrition education

Treatment

Sport nutrition education with peer testimonials on negative effects of REDs

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Over 18 years of age
  • Active to participate in training and competition
  • Able-bodied sport program
  • Having given informed consent

You may not qualify if:

  • Eating Disorder Examination Questionnaire 6.0 total score \> 2.50 (women) and \> 1.68 (male)
  • Unable to understand spoken and written English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H9X 3V9, Canada

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Central Study Contacts

Anne-Sophie Brazeau, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 2, 2023

Study Start

August 22, 2022

Primary Completion

April 1, 2024

Study Completion

April 30, 2024

Last Updated

December 6, 2023

Record last verified: 2023-11

Locations