Relative Energy Deficiency in SportNCT06116097
Effect of Nutrition Education on Energy Availability, Body Composition, Eating Attitude and Sports Nutrition Knowledge
A study testing Nutrition education in people with Relative Energy Deficiency in Sport, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effects of a series of nutrition education sessions conducted by a registered dietitian on energy availability, various anthropometric measurements, eating attitudes, and sports nutrition knowledge in young female endurance athletes aged 15-18 years (football, basketball, volleyball) who… Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Relative Energy Deficiency in Sport
- What is being tested?
- Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 28 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Non-contraceptive using Competitive female endurance athletes 14-18 years of age training minimum 6 hours a week not taking a break from sports for more than 3 months due to injury
Who cannot join
- Pregnancy or planned pregnancy chronic diseases (e.g. diabetes, crohn's disease, thyroid dysfunction) Use of any medication that may disturb hormonal balance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baltalimanı Research and Training Hospital
Istanbul, Sarıyer
About this study
Official title: The Effect of Nutrition Education Sessions on Energy Availability, Body Composition, Eating Attitude and Sports Nutrition Knowledge in Young Female Endurance Athletes
This study investigates the effects of a series of nutrition education sessions conducted by a registered dietitian on energy availability, various anthropometric measurements, eating attitudes, and sports nutrition knowledge in young female endurance athletes aged 15-18 years (football, basketball, volleyball) who engage in training for more than 10 hours per week (n=83).
Read the detailed description
Participants were randomly divided into two groups with 45 individuals receiving six physical nutrition education lectures, and the remaining 38 participants receiving no nutrition education. Participants completed the The low energy availability in females questionnaire (LEAF-Q), Eating Attitude Test (EAT-26) and Sports Nutrition Knowledge Questionnaire (SNKQ). Energy and nutrient intakes were evaluated thorough 3-day food records, while exercise energy expenditure was assessed using 3-day activity logs. All of the questionnaires were repeated after a 6-months period.
At baseline, the prevalence of LEA among athletes was determined to be 63.8%. In the intervention group, energy availability (EA) and SNKQ scores increased, and LEAF-Q scores decreased significantly (p < 0.05). However, there was no significant change in EAT-26 scores between the two groups. Energy intake, weight, fat free mass and resting metabolic rate has been increased significantly in the intervention group (p < 0,05). These findings suggest that nutrition education proves beneficial in enhancing dietary intake, positively influencing body composition and improving nutrition knowledge, ultimately contributing to increased energy availability in female athletes over the short term.
- Conditions
- Relative Energy Deficiency in Sport
- Being tested
- Nutrition education
- Medical subject headings
- Relative Energy Deficiency in Sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition educationBehavioural
Fifty participants took 6 physical nutrition education lectures and the other group (n=33) didn't have any nutrition education. Nutrition education was comprimised of 6 physical face to face 60 minutes sessions which was given every week in a school class. Each session was consisted of a different subject including energy metabolism in sport, energy balance, nutrition before and after training, low energy availability, macro and micronutrients, hydration and supplements. Participants also got written information as a printed booklet in order to be able to take notes under sessions and review after the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition education intervention group | Experimental | Nutrition education was comprimised of 6 physical face to face 60 minutes sessions which was given every week in a school class. Each session was consisted of a different subject including energy metabolism in sport, energy balance, nutrition before and after training, low energy availability, macro and micronutrients, hydration and supplements. Participants also got written information as a printed booklet in order to be able to take notes under sessions and review after the sessions. Receives: Behavioral: Nutrition education |
| Control group | No intervention | Control group has not taken any nutrition education but has been filled all of the questionnaires, acitivity logs and food diaries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Availability
Energy availability (EA) is described as the amount of energy left over and available for proper organism functions after the energy used for exercise is subtracted from the calories taken in the diet, by American College of Sports Medicine. It is shown that the young athletes often fail to follow the recommended dietary guidelines for their sport and activity level. Therefore that poses risk for low energy availability (LEA) EA below 30 kcal/kg FFM was considered to be low EA, EA between 30-45 kcal/kg was considered to be reduced and EA>45 kcal/kg was considered to be optimal.
Measured: 6 months
Low Energy Availability Questionnaire (LEAF-Q)
The 25-item LEAF-Q was used to assess the risk of LEA. The LEAF-Q has been validated in female athletes aged 18-39 training ≥5 times/week, with findings producing an acceptable sensitivity (78%) and specificity (90%) to classify current energy availability[28]. Consistent with the original validation study players completed a paper version of the LEAF-Q to ensure validity and reliability were maintained. Scoring was based on the original validation study, with those who scored ≤7 being classified as 'not at risk' of LEA, and those who scored ≥8 being classified as 'at risk' of LEA[28].
Measured: 6 months
Secondary outcomes (8)
Sports nutrition knowledge questionnaire (SNKQ)
Players completed the 88-item Sports Nutrition Knowledge Questionnaire (SNKQ) at pre and post intervention.The SNKQ has been assessed for validity (content and construct) and reliability (test-retest), with findings indicating a high construct validity and good test-retest concordance and therefore suitability to be used to determine sports nutrition knowledge. The SNKQ consists of five sub-sections (general nutrition concepts, fluid, recovery, weight control and supplements). One point was awarded for each correct answer, and an 'unsure' or incorrect response received zero points. The scores for each subsection and total score were calculated based on the number of questions answered correctly with a maximum total score of 83.
Measured: 6 months
Eating Atittude Test (EAT-26)
EAT-26 has been used to assess eating disorder risks in many populations, including athletes. As recommended by the developers of the EAT-26 tool, scores of 20 or above on the EAT-26 assessment indicated eating disorder behaviors. Scores falling below 20 were assessed as low risk for eating disorder behaviors
Measured: 6 months
Dietary intake
The mean daily intake of energy, macronutrients and some of the micronutrients over the three days (two weekdays, one weekend) was calculated. Participants used household measures to estimate intake. Dietary intake data was entered into BEBIS 6.1 nutrition analysis program. (Beslenme Bilgi sistemi, Turkey) Daily energy, protein, carbohydrate, fat and fiber intake was compared with the values reported in the current nutrition guidelines.
Measured: 6 months
Exercise Energy Expenditure
Exercise energy expenditure (EEE) has been calculated according to the 3-day activity logs in the beginning of the season. Activity logs (including activity, exercise duration and rest periods) for resistance and any non-club based activities under 3 days were completed and assigned a Metabolic Equivalent (MET) value from the compendium of physical activities
Measured: 6 months
Fat-free mass
at-free mass (FFM) is the primary determinant of TEE in all age groups.
Measured: 6 months
Body Mass Index (BMI)
Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters.Low BMI was defined as BMI <18.5 kg/m2 as recommended when screening athletes for risk of LEA.
Measured: 6 months
Basal metabolic rate (BMR)
he amount of energy expended while at rest in a neutrally temperate environment, and in a post-absorptive state (meaning that the digestive system is inactive, which requires about 12 hours of fasting)
Measured: 6 months
Fat mass
Body fat can be predictor for eating disorder risk status.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Apr 2019
- Primary completion1 Sep 2019
- Study completion28 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relative Energy Deficiency in SportStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A total of 83 adolescent female elite athletes from 3 different sport clubs (football n=34, basketball n=16 and volleyball n=33) between 15 and 18 years(mean 17.2 ± 2.0) were included in the study.They were divided into either the intervention or the control groupby simple randomization. Fortyfem participants took 6 physical nutrition education lectures and the other group (n=38) didn't have any nutrition education. All of them filled the LEAF-Q (Low energy availability in athletes questionnaire),EAT-26(Eating Attitude Test)and SNKQ (Sports Nutrition Knowledge Questionnaire).Energy and nutrient intakes were assessed based on 3-day food records. Activity logs were analysed to measure exercise energy expenditure. All of the tests have been repeated after 6 months. Nutrition education was comprised of 6 physical 60 minutes sessions given every week in a school class. Each session was consisted of a different subject. Participants got written information as a printed booklet.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Tektunalı Akman, Medipol University
- Investigators
- Cansu T Akman, MS, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116097
- Sponsor's protocol ID
- E.8234/196
- Status last verified
- Mar 2024
- First submitted
- 30 Oct 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrition Education Sessions on Energy Availability, Body Composition, Eating Attitude and Sports Nutrition Knowledge in Young Female Endurance Athletes
- ClinicalTrials.gov ID
- NCT06116097
- Acronym / sponsor ID
- E.8234/196
- Conditions
- Relative Energy Deficiency in Sport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 28 Mar 2020 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effects of a series of nutrition education sessions conducted by a registered dietitian on energy availability, various anthropometric measurements, eating attitudes, and sports nutrition knowledge in young female endurance athletes aged 15-18 years (football, basketball, volleyball) who engage in training for more than 10 hours per week (n=83).
Detailed description
Participants were randomly divided into two groups with 45 individuals receiving six physical nutrition education lectures, and the remaining 38 participants receiving no nutrition education. Participants completed the The low energy availability in females questionnaire (LEAF-Q), Eating Attitude Test (EAT-26) and Sports Nutrition Knowledge Questionnaire (SNKQ). Energy and nutrient intakes were evaluated thorough 3-day food records, while exercise energy expenditure was assessed using 3-day activity logs. All of the questionnaires were repeated after a 6-months period.
At baseline, the prevalence of LEA among athletes was determined to be 63.8%. In the intervention group, energy availability (EA) and SNKQ scores increased, and LEAF-Q scores decreased significantly (p < 0.05). However, there was no significant change in EAT-26 scores between the two groups. Energy intake, weight, fat free mass and resting metabolic rate has been increased significantly in the intervention group (p < 0,05). These findings suggest that nutrition education proves beneficial in enhancing dietary intake, positively influencing body composition and improving nutrition knowledge, ultimately contributing to increased energy availability in female athletes over the short term.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 83 adolescent female elite athletes from 3 different sport clubs (football n=34, basketball n=16 and volleyball n=33) between 15 and 18 years(mean 17.2 ± 2.0) were included in the study.They were divided into either the intervention or the control groupby simple randomization. Fortyfem participants took 6 physical nutrition education lectures and the other group (n=38) didn't have any nutrition education. All of them filled the LEAF-Q (Low energy availability in athletes questionnaire),EAT-26(Eating Attitude Test)and SNKQ (Sports Nutrition Knowledge Questionnaire).Energy and nutrient intakes were assessed based on 3-day food records. Activity logs were analysed to measure exercise energy expenditure. All of the tests have been repeated after 6 months. Nutrition education was comprised of 6 physical 60 minutes sessions given every week in a school class. Each session was consisted of a different subject. Participants got written information as a printed booklet.
| Arm | Type | Receives |
|---|---|---|
| Nutrition education intervention group | Experimental | Behavioral: Nutrition educationNutrition education was comprimised of 6 physical face to face 60 minutes sessions which was given every week in a school class. Each session was consisted of a different subject including energy metabolism in sport, energy balance, nutrition before and after training, low energy availability, macro and micronutrients, hydration and supplements. Participants also got written information as a printed booklet in order to be able to take notes under sessions and review after the sessions. |
| Control group | No intervention | –Control group has not taken any nutrition education but has been filled all of the questionnaires, acitivity logs and food diaries. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Non-contraceptive using Competitive female endurance athletes 14-18 years of age training minimum 6 hours a week not taking a break from sports for more than 3 months due to injury
Key exclusion criteria (1 listed)
- Pregnancy or planned pregnancy chronic diseases (e.g. diabetes, crohn's disease, thyroid dysfunction) Use of any medication that may disturb hormonal balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition educationFifty participants took 6 physical nutrition education lectures and the other group (n=33) didn't have any nutrition education. Nutrition education was comprimised of 6 physical face to face 60 minutes sessions which was given every week in a school class. Each session was consisted of a different subject including energy metabolism in sport, energy balance, nutrition before and after training, low energy availability, macro and micronutrients, hydration and supplements. Participants also got written information as a printed booklet in order to be able to take notes under sessions and review after the sessions. | Behavioural | Nutrition education intervention group |
Primary outcome
Energy Availability
Time frame: 6 months
Energy availability (EA) is described as the amount of energy left over and available for proper organism functions after the energy used for exercise is subtracted from the calories taken in the diet, by American College of Sports Medicine. It is shown that the young athletes often fail to follow the recommended dietary guidelines for their sport and activity level. Therefore that poses risk for low energy availability (LEA) EA below 30 kcal/kg FFM was considered to be low EA, EA between 30-45 kcal/kg was considered to be reduced and EA>45 kcal/kg was considered to be optimal.
Low Energy Availability Questionnaire (LEAF-Q)
Time frame: 6 months
The 25-item LEAF-Q was used to assess the risk of LEA. The LEAF-Q has been validated in female athletes aged 18-39 training ≥5 times/week, with findings producing an acceptable sensitivity (78%) and specificity (90%) to classify current energy availability[28]. Consistent with the original validation study players completed a paper version of the LEAF-Q to ensure validity and reliability were maintained. Scoring was based on the original validation study, with those who scored ≤7 being classified as 'not at risk' of LEA, and those who scored ≥8 being classified as 'at risk' of LEA[28].
8 secondary outcomes
Sports nutrition knowledge questionnaire (SNKQ)
Time frame: 6 months
Eating Atittude Test (EAT-26)
Time frame: 6 months
Dietary intake
Time frame: 6 months
Exercise Energy Expenditure
Time frame: 6 months
Fat-free mass
Time frame: 6 months
Body Mass Index (BMI)
Time frame: 6 months
Basal metabolic rate (BMR)
Time frame: 6 months
Fat mass
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cansu T Akman, MS principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education in people with Relative Energy Deficiency in Sport, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Availability (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.