Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05709678 |
| Other study ID # |
22-05-051-02 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 22, 2022 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
McGill University |
| Contact |
Erik Sesbreno, MSc |
| Phone |
514-291-4830 |
| Email |
erik.sesbreno[@]mail.mcgill.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Study Design
The duration of the study will be 3-weeks and 30 participants will be recruited. Participants
will complete the EDE-Q 6.0 to examine inclusion and exclusion criteria to participate in the
study. When enrollment to participate is confirmed and informed consent is received,
participants will complete the platform to evaluate athlete knowledge of sports nutrition
questionnaire (PEAK-NQ) and three factor eating questionnaire (TFEQ)-R18 (cognitive restraint
eating subscale only), Low energy availability male or female questionnaire (LEAM- or LEAF-Q)
on day 1, a 5-day food intake journal from day 2 to 6 and the food management questionnaire,
athlete diet index questionnaire (ADI), athlete food choice questionnaire (AFCQ)and surface
anthropometry on day 7.
Participants will be randomly assigned to a group nutrition education treatment program. The
programs will be in a classroom setting (60min for treatment group and 45min for the control
group) at the end of the first week (day 8). Post assessment will be scheduled over week 3
and will include the completion of the 5-day food intake journal from day 15 to day 20 and
EDE-6.0 (weight and shape concern subscales only), TFEQ-R18 (cognitive restraint eating
subscale only), ADI questionnaire, PEAK-NQ, AFCQ, and surface anthropometry on day 21.
The investigator will be onsite on day 1, 7, 8 and 21. This will allow the investigator to
clarify any missing or incomplete items with the participant in person at INS Québec and/or
the Volleyball Canada national training centre.
Randomization The randomization procedure will occur via blocked randomization with
stratification for high and low PEAK-NQ score (separated with the median score of a similar
reference group (Tam et al., 2021). In the case of chance imbalances between groups a
minimization design will be applied (Vickers, 2006). The process of randomization will be
completed by the investigator.
The project will be staged at Volleyball Canada's National training centre and/or the
Institut National du Sport du Québec (INS Québec). INS Québec is a national multisport
training and sport science/medical service institute for more than 10 national elite sport
programs. Despite disruptions related to the COVID 19 pandemic, INS Québec (Montreal) and
Volleyball Canada national training centre (Gatineau) has been allowed under provincial
government permission to adapt operations to accommodate training requirements for elite
amateur athletes preparing for the upcoming international events such as the Summer/Winter
Olympics and Paralympic games, World Championships and among others. As long as
recommendations to manage COVID-19 transmission are strictly implemented as per respective
management documents , the investigation will be able to operate as scheduled.
MEASUREMENTS AND STUDY INSTRUMENTS
Surface Anthropometry Anthropometric profiles, including body mass, standing height, bone
breadths at two sites, limb girths at two sites and skinfolds at eight sites will be measured
by a level III accredited anthropometrist from the International Society for the Advancement
of Kinanthropometry (ISAK) with a technical error of measurement of ≤ 2.0% for sum of eight
skinfolds and ≤ 1.0% for all other measures. All measurements will be made on the right side
of the body using ISAK techniques previously described (Stewart et al., 2011). Standing
height will be measured using a stadiometer (Rosscraft, Surrey, BC, Canada), body mass on a
calibrated digital scale with a precision of ± 0.1 kg (BWB-800S Tanita, Illinois, USA),
girths with a flexible steel measuring tape (Rosscraft, Surey, BC, Canada), bone breadth with
small bone caliper (Rosscraft, Surrey, BC, Canada) and skinfolds with a Harpenden calipers
(Baty International, Burgess Hill, England). The calculations of lean mass index and
anthropometric somatotype will be performed as previously described (Norton and Olds, 1996 &
Slater et al., 2006).
Platform to Evaluate Athlete Knowledge of Sports Nutrition Questionnaire (PEAK-NQ) Athlete
knowledge on sport nutrition will be assessed through a validated 50-item electronic
questionnaire (Tam et al., 2021). It is based on a total score of 75 across two sections:
General Nutrition and Sports Nutrition. Correct answers are given one mark. Incorrect and
"not sure" responses are given a zero mark. The items with multiple correct answers score one
mark per correct answer and are deducted one mark per incorrect option. Negative scores
resulting from multiple incorrect answers are adjusted to zero.
Athlete Food Choice Questionnaire (AFCQ) To account for factors that reportedly influence
food choices in elite athletes will be assessed by the AFCQ. It is a validated 32-items
questionnaire to assess 9-factors influencing food choices in elite athletes (Thurecht et
al., 2021). Items are presented as neutral statements and participants rank each on a
frequency scale from 1 (never) to 5 (always). Food choice will be referred to foods and
beverages.
Athlete Diet Index (ADI) The participants eating habits will be assess with the ADI
questionnaire. It is a food frequency questionnaire based on reported habits over the last 7
days and was validated in elite athletes across multiple sport disciplines (Capling et al,
2021). A total score (out of a possible 125) is calculated from the sum of the individual
sub-scores; with a higher score indicating greater compliance with dietary recommendations
for healthy and sport performance/recovery. The total ADI score, sub-scores, and non-scored
information (ie: 7 day training log, dietary supplement use) are used in combination to
provide an indication of overall diet quality and dietary patterns of the athletes. Although
the sub-score for healthy eating are based on the Australian guidelines to healthy eating,
the principals are similar to the Canadian Food Guide and will therefore be included in the
group analysis (Government of Canada, n.d. & and Australian Government, n.d.). Non scored
data is also collected such as medical illness, injuries, weight goals, training schedule,
education level as descriptive data to help contextualize the dietary trends and scores.
Dietary Intake Journal Each athlete will complete a 5-consecutive day dietary intake report
within the week while using the Keenoa (Montréal, Québec, Canada) phone application (Ji et
al, 2020). The intake assessment will include a day of rest, and 4 days of coach directed
training. Athletes will receive detailed online instructions on how to record all food, fluid
and dietary supplement intake. During this investigation, the researcher will use the
participant's email to send an invitation to download the app on their smartphone, which will
connect the user to the investigator. Participants will be asked to weigh and take pictures
of each food item with their smartphone prior to consumption. A food scale will be provided
to facilitate data capture. If the app recognizes the food item(s), it will display selected
options for the users to confirm the right identity of the food. Items could range from a
single item (ie: apple) to composite items (ie: lasagna). Alternatively, participants could
search and record food items manually from a database linked to the Canadian Nutrient File
(2015). If the athlete ate out, or is unable to find a suitable food match among the
available choices on the app, they will be instructed to provide the name of the restaurant
food, and fluid orders with size; or name of the food with brand and portion size,
respectively, to enable cross-checking. The investigator will review all dietary records and
analysis reports for consistency.
Food Management Questionnaire This non-validated questionnaire will be used to describe some
basic factors associated with the athlete's capability based on the COM-B model to manage
food and fluid availability and preparation for oral consumption during the training week. It
is divided into 3 main subcategories such as culinary environment at his/her place of
residence, food availability and food preparation.
Low Energy Availability in Females Questionnaire (LEAF-Q) Female participants will complete a
25-item questionnaire to screen for self-reported physiological symptoms related to low
energy availability (Melin et al., 2014). Participants will be subsequently categorized as
being at risk for the RED-S if their total score is ≥8.
Low energy availability male questionnaire (LEAM-Q) Participants will complete a 42-item
questionnaire to screen for self-reported physiological symptoms related to low energy
availability (Lundy et al., 2022). Higher total scores indicate a higher relative risk of low
energy availability, but with a lower sex-drive being a more sensitive indicator. Low sex
drive is identified when 2 or more score on A1 or 2 or more is scored on B1 and 1 or more on
B2.
Eating Disorder Examination Questionnaire (EDE-Q 6.0) All participants will complete a
28-item questionnaire derived from the semi-structured interview Eating Disorder Examination
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 (Fairburn et al, 2008). It focuses on the past 28 days and uses a seven-point rating
scale (0-6). Total score > 2.5 to ensure vulnerable subgroups are not subjected to mental
health triggers that may encourage problems with eating (Kuikman et al., 2021). The 2
subscales related to shape and weight concerns will be used at each time point to assess
change in self reported concerns with physique.
Three Factor Eating Questionnaire R18 (TFEQ-R18) The TFEQ-R18 refers to current dietary
practice and measures 3 different aspects of eating behavior: restrained eating (conscious
restriction of food intake to control body weight or to promote weight loss), uncontrolled
eating (tendency to eat more than usual due to a loss of control over intake accompanied by
subjective feelings of hunger), and emotional eating (inability to resist emotional cues) (de
Lauzon et al., 2004). The questionnaire consists of 18 items on a 4-point response scale and
items are scored, summated and transformed into a 0-100 scale for each behaviour as
previously described. Higher scores in the respective scales indicate greater cognitive
restraint, uncontrolled, or emotional eating. For the purpose of this investigation, the
questions for calculating the cognitive restraint eating behaviours score will only be used
at each testing time point to characterize restraint eating. The TFEQ-R18 restraint eating
score (questions 2, 11, 12, 15, 16 and 18) was selected over EDE-Q 6.0 restraint eating score
because it has been associated with athletes at risk of LEA/RED-S as well as surrogate
markers of LEA in the athletic population (Jurov et al., 2021, Viner et al., 2015 and
Sesbreno et al., 2022, in preparation).
Intervention Treatment
Participants randomized in the intervention group will undertake a classroom group education
session (60min) to cover a variety of sub-themes aimed to increase caloric intake (primarily
via protein and carbohydrate intake) over the national team training camp. The content will
be administered via power point by the investigator. The session will be recorded to examine
content delivery for the assessment of fidelity. The content is design to deliver
interventions related to 3 source behaviours associated with the COM-B model of behaviour
change. Educational content will be independently coded by two registered dietitians on the
research team based on the Behaviour Change Taxonomy code (http://www.bct-taxonomy.com/).
Agreement between raters is required to confirm the coding. If failure to agree after three
attempts, a third dietitian on the research team will independently code. The coding results
by popular vote will confirm the coding. Topics covered will include:
1. Food knowledge (Capability - Psychological)
- Macronutrients for energy (protein, carbs, fat)
- Foods/fluids rich in protein, carbs, fats
- Key nutrients iron, calcium, and water
2. Sport Nutrition Knowledge (Capability - Psychological)
- Energy requirements between rest, single and double training days
- Daily protein requirements for recovery and training response
- Carbohydrate requirements for pre-practices and post practices
- Fluid requirements over the day, during training and immediately after practice
3. Culinary and menu planning knowledge (Opportunity - Psychological/Physical)
• Basic menu planning guidelines
4. Low energy availability and association on health and performance outcomes (Motivational
- Reflective - Education and persuasion)
- Link between restrain eating and physique traits
- What is LEA and RED-S and prevalence in Olympic level athletes
- Link between restrain eating and LEA risk in elite athletes
- Link between LEA and risk of poor health in elite athletes
- Link between LEA and risk of poor jumping performance and reaction time in elite
athletes
- Athlete testimonials on consequences to health outcomes
Control Treatment
Participants randomized in the control group will undertake a classroom group education
session (45min) to cover a variety of sub-themes aimed to increase caloric intake (primarily
via protein and carbohydrate intake) over the national team training camp. The content will
be administered via power point by the investigator. The session will be recorded to examine
content delivery for the assessment of fidelity. The content is design to deliver
interventions related to 2 source behaviours associated with the COM-B model of behaviour
change. Topics covered will include:
1. Food knowledge (Capability - Psychological)
- Macronutrients for energy (protein, carbs, fat)
- Foods/fluids rich in protein, carbs, fats
- Key nutrients iron, calcium, and water
2. Sport Nutrition Knowledge (Capability - Psychological)
- Energy requirements between rest, single and double training days
- Daily protein requirements for recovery and training response
- Carbohydrate requirements for pre-practices and post practices
- Fluid requirements over the day, during training and immediately after practice
3. Culinary and menu planning knowledge (Opportunity - Psychological/Physical)
• Basic menu planning guidelines
4. Low energy availability and association on health and performance outcomes (Motivational
- Reflective - Education (only))
- Link between restrain eating and physique traits
- What is LEA and RED-S and prevalence in Olympic level athletes
- Link between restrain eating and LEA risk in elite athletes
- Link between LEA and risk of poor health in elite athletes
- Link between LEA and risk of poor jumping performance and reaction time in elite
athletes
Both groups will receive a copy of the power-point slides to review sections:
1. Food knowledge
2. Sport Nutrition Knowledge
3. Culinary and menu planning knowledge
