Nutrition, HealthyNCT06275802
The Effect of Nutrition Education Interventions for Adolescents
A study testing Nutrition Education and nutritional status, eating habits in people with Nutrition, Healthy and Nutrition Disorders in Adolescence, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of nutrition education on nutritional literacy, nutritional status, eating habits and eating behavior in high school students. The research will be conducted in six high schools, three of which are intervention schools and three of which are control schools It is… Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Nutrition Disorders in Adolescence, Eating Habit
- What is being tested?
- Nutrition Education and nutritional status, eating habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2022to 30 Jun 2024
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- studying in the 9th and 10th grades in the selected schools
- agree to participate in the research
Who cannot join
- Type 1 diabetes
- Metabolic disorders (Phenylketonuria, Maple Syrup Urine Disease, Galactosaemia ect.)
- Pediatric Malabsorption (Celiac, cystic fibrosis, congenital sucrase isomaltase deficiency ect.)
- require a special diet
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Menemen District Directorate of National Education
Izmir
Sibel ÖZER, (0232) 832 26 29
About this study
Official title: The Effect of Nutrition Education Interventions on Nutritional Status, Nutritional Habits and Eating Behaviors in Adolescents
The aim of this study is to determine the effect of nutrition education on nutritional literacy, nutritional status, eating habits and eating behavior in high school students. The research will be conducted in six high schools, three of which are intervention schools and three of which are control schools It is planned that a total of 1000 students will be included in the study from the intervention school and 1000 students from the control school. At the beginning of the study (June 2022), an introductory form (sociodemographic characteristics, body image (Stunkart scale), dietary habits, knowledge about weight status) was applied to all students. Adolescent Nutrition Literacy Scale (ANLS), Instrument of Nutrition Literacy, Mediterranean Diet Quality Index (KID-MED), Eating Attitudes Test 26 (EAT-26), International Physical Activity Questionnaire Short Form (IPAQ) were applied, anthropometric measurements and three-day food consumption records were taken. During the study, nutrition initiatives consisting of 8 modules will be made to the intervention schools. Control schools will not be interfered with during this period.At the end of the study, the procedures applied at the beginning will be repeated.
Read the detailed description
Lack of knowledge about nutrition is one of the most important causes of nutritional problems. accordingly, wrong eating practices and habits can lead to many complications and health problems. Especially adolescent eating habits form the basis of adult eating habits. The habits acquired during this period can lead to behaviors and attitudes that persist for a long time and are difficult to change.The aim of this study is to determine the effect of nutrition education on nutritional literacy, nutritional status, eating habits and eating behavior in high school students. The research will be conducted in six high schools, three of which are intervention schools and three of which are control schools. Schools in the district will be divided into 3 layers as 1- Anatolian High Schools, 2- Technical and Vocational High Schools, 3- Imam Hatip High Schools, and a control school will be determined from each layer by means of a random numbers table. It is planned that a total of 1000 students will be included in the study from the intervention school and 1000 students from the control school. At the beginning of the study (June 2022), an introductory form (sociodemographic characteristics, body image (Stunkart scale), dietary habits, knowledge about weight status) was applied to all students. Adolescent Nutrition Literacy Scale (ANLS), Instrument of Nutrition Literacy, Mediterranean Diet Quality Index (KID-MED), Eating Attitudes Test 26 (EAT-26), International Physical Activity Questionnaire Short Form (IPAQ) were applied, anthropometric measurements and three-day food consumption records were taken. During the study, nutrition initiatives consisting of 8 modules (powerpoint supported classroom lesson, video demonstration, role-play, healthy plate model game, poster preparation, bookmarks, refrigerator magnets, etc. preparation of reminder messages, competitions such as slogan-painting contest, activities such as sports and nutrition festival) will be made to the intervention schools. Control schools will not be interfered with during this period.At the end of the study, the procedures applied at the beginning (anthropometic measurements, introductory form, scales, food consumption record) will be repeated.
- Conditions
- Nutrition, Healthy, Nutrition Disorders in Adolescence, Eating Habit, Eating Behavior, Body Image
- Being tested
- Nutrition Education, nutritional status, eating habits
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition EducationBehavioural
Nutrition interventions consisting of 8 modules (powerpoint supported classroom lesson, video demonstration, role-play, healthy plate model game, poster preparation, bookmarks, refrigerator magnets, etc. preparation of reminder messages, competitions such as slogan-painting contest, activities such as sports and nutrition festival).
nutritional status, eating habitsBehavioural
At the beginning of the study (June 2022), an introductory form (sociodemographic characteristics, body image (Stunkart scale), dietary habits, knowledge about weight status) was applied to all students. Adolescent Nutrition Literacy Scale (ANLS), Instrument of Nutrition Literacy, Mediterranean Diet Quality Index (KID-MED), Eating Attitudes Test 26 (EAT-26), International Physical Activity Questionnaire Short Form (IPAQ) were applied, anthropometric measurements and three-day food consumption records were taken
| Study group | Role | What they receive |
|---|---|---|
| Intervention schools (educated about nutrition) | Experimental | The research will be conducted in six high schools, three of which are intervention schools . Schools in the district will be divided into 3 layers as 1- Anatolian High Schools, 2- Technical and Vocational High Schools, 3- Imam Hatip High Schools. Receives: Behavioral: Nutrition Education; Behavioral: nutritional status, eating habits |
| Control schools (non-educated about nutrition) | Sham comparator | The research will be conducted in six high schools, three of which are control schools. Schools in the district will be divided into 3 layers as 1- Anatolian High Schools, 2- Technical and Vocational High Schools, 3- Imam Hatip High Schools, and a control school will be determined from each layer by means of a random numbers table Receives: Behavioral: nutritional status, eating habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
nutrition literacy
To investigate the effects of nutrition education interventions on nutrition literacy. We use Adolescent Nutrition Literacy Scale and Instrument of Nutrition Literacy scale to evaluate the nutrition literacy.
Measured: up to 10 months
Mediterranean Diet Quality Index (KID-MED)
In KIDMED, which is a scale consisting of sixteen questions, each question is answered "Yes" or "No". The scale includes 12 questions about eating habits appropriate for the Mediterranean diet and 4 questions about eating habits not appropriate for the Mediterranean diet. If "Yes" is answered to the questions questioning the eating habits appropriate for the Mediterranean diet, +1 point is obtained, if "Yes" is answered to the questions questioning the eating habits not appropriate for the Mediterranean diet, -1 point is obtained, and 0 point is obtained when no answer is given to the questions. The lowest score that can be obtained from the scale is -4 and the highest score is 12. The total score obtained from the scale is evaluated in three groups as optimal (good) diet quality if it is 8 and above (≥8 points), diet quality that needs to be improved (moderate) if it is between 4-7 points, and very low diet quality (low) if it is 3 and below (≤3 points).
Measured: up to 10 months
Eating Attitudes Test 26 (EAT-26)
It is used to determine whether there is an eating disorder. It is a 6-point Likert-type test consisting of a total of 26 questions. The answers include "always, very often, often, sometimes, rarely, never". A minimum score of "0" and a maximum score of "78" can be obtained from the test. If the test score is above 20, there is a risk of eating behaviour disorder. If the test score is below 20, there is no risk of eating behaviour disorder.
Measured: up to 10 months
weight and height measurement
Height measurement will be made with a portable height meter supported by the wall with light clothes without shoes, with the head upright, looking straight ahead, the line passing through the eyes and ears parallel to the ground, legs straight and closed, arms at the side, shoulders relaxed, heels, hips and shoulders on the Frankfurt plane against the wall.
Weight measurement will be done with a 100 g sensitive digital scale.
BMI will be obtained by dividing weight (kg) by the square of height (m), and age and gender appropriate percentile values will be determined. 85-95 percentile will be classified as overweight and ≥95 percentile as obese.
Measured: up to 10 months
waist circumference measurement
Waist circumference will be measured with the help of a non-flexible tape measure, with light clothes, while breathing normally, standing upright, with arms outstretched on both sides, at the point passing through the exact midpoint between the lower ribs and the hip bone.
Measured: up to 10 months
Food Consumption Record
The food consumption record form will be filled in by the researcher for 3 days with 24 hour reminder method. Food and food photo catalogues will be used to determine the measurements and quantities of food consumption. The amount of nutrients included in the meals consumed by the individuals will be calculated using standard recipes. Average energy and nutrient values of the food/drinks consumed will be calculated using the BEBIS programme. In the evaluation of energy and nutrient intakes, recommended daily energy and nutrient values according to gender and age will be used. Accordingly, those who consume ± 50% of the recommended amount of energy and nutrients will be considered adequate (50-150%), and those who consume < 50% will be considered inadequate (50%).
Measured: up to 10 months
International Physical Activity Questionnaire (IPAQ- Short Form)
It was developed by Craig et al. to determine the physical activity status of individuals (Craig et al., 2003). It is a 7-question form whose Turkish validity and reliability was performed by Öztürk (Öztürk, 2005). In this form in which walking, moderate activity, vigorous activity and time spent sitting are questioned, weekly MET values of individuals are calculated and individuals are classified as inactive, minimally active and very active according to the results. A score is obtained as "MET/min/week" by multiplying the minutes, days and MET values of the physical activity performed. In the calculation of the walking score, a walking time of 3.3 METs, 4 METs for moderate physical activity and 8 METs for vigorous physical activity are accepted. If the calculated value is 3000 MET/min/week, it is classified as very active
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start6 Jun 2022
- Primary completion30 Dec 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by Ege 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Nagihan AKDER, Ege University
- Investigators
- Murat URHAN, PhD, Principal investigator, Ege UniversityEzgi KARATAŞ, PhD, Principal investigator, Ege UniversityRana N AKDER, Msc, Principal investigator, Ege UniversityCeren AKANALÇI, Msc, Principal investigator, Ege UniversityReci MESERİ, PhD, Principal investigator, Ege UniversityÖzge KÜÇÜKERDÖNMEZ, PhD, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275802
- Sponsor's protocol ID
- 22-5.1T/2
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2023
- Last updated
- 23 Feb 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrition Education Interventions on Nutritional Status, Nutritional Habits and Eating Behaviors in Adolescents
- ClinicalTrials.gov ID
- NCT06275802
- Acronym / sponsor ID
- 22-5.1T/2
- Conditions
- Nutrition, Healthy, Nutrition Disorders in Adolescence, Eating Habit, Eating Behavior, Body Image
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 23 Feb 2024 (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.
The aim of this study is to determine the effect of nutrition education on nutritional literacy, nutritional status, eating habits and eating behavior in high school students. The research will be conducted in six high schools, three of which are intervention schools and three of which are control schools It is planned that a total of 1000 students will be included in the study from the intervention school and 1000 students from the control school. At the beginning of the study (June 2022), an introductory form (sociodemographic characteristics, body image (Stunkart scale), dietary habits, knowledge about weight status) was applied to all students. Adolescent Nutrition Literacy Scale (ANLS), Instrument of Nutrition Literacy, Mediterranean Diet Quality Index (KID-MED), Eating Attitudes Test 26 (EAT-26), International Physical Activity Questionnaire Short Form (IPAQ) were applied, anthropometric measurements and three-day food consumption records were taken. During the study, nutrition initiatives consisting of 8 modules will be made to the intervention schools. Control schools will not be interfered with during this period.At the end of the study, the procedures applied at the beginning will be repeated.
Detailed description
Lack of knowledge about nutrition is one of the most important causes of nutritional problems. accordingly, wrong eating practices and habits can lead to many complications and health problems. Especially adolescent eating habits form the basis of adult eating habits. The habits acquired during this period can lead to behaviors and attitudes that persist for a long time and are difficult to change.The aim of this study is to determine the effect of nutrition education on nutritional literacy, nutritional status, eating habits and eating behavior in high school students. The research will be conducted in six high schools, three of which are intervention schools and three of which are control schools. Schools in the district will be divided into 3 layers as 1- Anatolian High Schools, 2- Technical and Vocational High Schools, 3- Imam Hatip High Schools, and a control school will be determined from each layer by means of a random numbers table. It is planned that a total of 1000 students will be included in the study from the intervention school and 1000 students from the control school. At the beginning of the study (June 2022), an introductory form (sociodemographic characteristics, body image (Stunkart scale), dietary habits, knowledge about weight status) was applied to all students. Adolescent Nutrition Literacy Scale (ANLS), Instrument of Nutrition Literacy, Mediterranean Diet Quality Index (KID-MED), Eating Attitudes Test 26 (EAT-26), International Physical Activity Questionnaire Short Form (IPAQ) were applied, anthropometric measurements and three-day food consumption records were taken. During the study, nutrition initiatives consisting of 8 modules (powerpoint supported classroom lesson, video demonstration, role-play, healthy plate model game, poster preparation, bookmarks, refrigerator magnets, etc. preparation of reminder messages, competitions such as slogan-painting contest, activities such as sports and nutrition festival) will be made to the intervention schools. Control schools will not be interfered with during this period.At the end of the study, the procedures applied at the beginning (anthropometic measurements, introductory form, scales, food consumption record) will be repeated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention schools (educated about nutrition) | Experimental | Behavioral: Nutrition Education, Behavioral: nutritional status, eating habitsThe research will be conducted in six high schools, three of which are intervention schools . Schools in the district will be divided into 3 layers as 1- Anatolian High Schools, 2- Technical and Vocational High Schools, 3- Imam Hatip High Schools. |
| Control schools (non-educated about nutrition) | Sham comparator | Behavioral: nutritional status, eating habitsThe research will be conducted in six high schools, three of which are control schools. Schools in the district will be divided into 3 layers as 1- Anatolian High Schools, 2- Technical and Vocational High Schools, 3- Imam Hatip High Schools, and a control school will be determined from each layer by means of a random numbers table |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- studying in the 9th and 10th grades in the selected schools
- agree to participate in the research
Key exclusion criteria (4 listed)
- Type 1 diabetes
- Metabolic disorders (Phenylketonuria, Maple Syrup Urine Disease, Galactosaemia ect.)
- Pediatric Malabsorption (Celiac, cystic fibrosis, congenital sucrase isomaltase deficiency ect.)
- require a special diet
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 EducationNutrition interventions consisting of 8 modules (powerpoint supported classroom lesson, video demonstration, role-play, healthy plate model game, poster preparation, bookmarks, refrigerator magnets, etc. preparation of reminder messages, competitions such as slogan-painting contest, activities such as sports and nutrition festival). | Behavioural | Intervention schools (educated about nutrition) |
| nutritional status, eating habitsAt the beginning of the study (June 2022), an introductory form (sociodemographic characteristics, body image (Stunkart scale), dietary habits, knowledge about weight status) was applied to all students. Adolescent Nutrition Literacy Scale (ANLS), Instrument of Nutrition Literacy, Mediterranean Diet Quality Index (KID-MED), Eating Attitudes Test 26 (EAT-26), International Physical Activity Questionnaire Short Form (IPAQ) were applied, anthropometric measurements and three-day food consumption records were taken | Behavioural | Control schools (non-educated about nutrition), Intervention schools (educated about nutrition) |
Primary outcome
nutrition literacy
Time frame: up to 10 months
To investigate the effects of nutrition education interventions on nutrition literacy. We use Adolescent Nutrition Literacy Scale and Instrument of Nutrition Literacy scale to evaluate the nutrition literacy.
Mediterranean Diet Quality Index (KID-MED)
Time frame: up to 10 months
In KIDMED, which is a scale consisting of sixteen questions, each question is answered "Yes" or "No". The scale includes 12 questions about eating habits appropriate for the Mediterranean diet and 4 questions about eating habits not appropriate for the Mediterranean diet. If "Yes" is answered to the questions questioning the eating habits appropriate for the Mediterranean diet, +1 point is obtained, if "Yes" is answered to the questions questioning the eating habits not appropriate for the Mediterranean diet, -1 point is obtained, and 0 point is obtained when no answer is given to the questions. The lowest score that can be obtained from the scale is -4 and the highest score is 12. The total score obtained from the scale is evaluated in three groups as optimal (good) diet quality if it is 8 and above (≥8 points), diet quality that needs to be improved (moderate) if it is between 4-7 points, and very low diet quality (low) if it is 3 and below (≤3 points).
Eating Attitudes Test 26 (EAT-26)
Time frame: up to 10 months
It is used to determine whether there is an eating disorder. It is a 6-point Likert-type test consisting of a total of 26 questions. The answers include "always, very often, often, sometimes, rarely, never". A minimum score of "0" and a maximum score of "78" can be obtained from the test. If the test score is above 20, there is a risk of eating behaviour disorder. If the test score is below 20, there is no risk of eating behaviour disorder.
weight and height measurement
Time frame: up to 10 months
Height measurement will be made with a portable height meter supported by the wall with light clothes without shoes, with the head upright, looking straight ahead, the line passing through the eyes and ears parallel to the ground, legs straight and closed, arms at the side, shoulders relaxed, heels, hips and shoulders on the Frankfurt plane against the wall. Weight measurement will be done with a 100 g sensitive digital scale. BMI will be obtained by dividing weight (kg) by the square of height (m), and age and gender appropriate percentile values will be determined. 85-95 percentile will be classified as overweight and ≥95 percentile as obese.
waist circumference measurement
Time frame: up to 10 months
Waist circumference will be measured with the help of a non-flexible tape measure, with light clothes, while breathing normally, standing upright, with arms outstretched on both sides, at the point passing through the exact midpoint between the lower ribs and the hip bone.
Food Consumption Record
Time frame: up to 10 months
The food consumption record form will be filled in by the researcher for 3 days with 24 hour reminder method. Food and food photo catalogues will be used to determine the measurements and quantities of food consumption. The amount of nutrients included in the meals consumed by the individuals will be calculated using standard recipes. Average energy and nutrient values of the food/drinks consumed will be calculated using the BEBIS programme. In the evaluation of energy and nutrient intakes, recommended daily energy and nutrient values according to gender and age will be used. Accordingly, those who consume ± 50% of the recommended amount of energy and nutrients will be considered adequate (50-150%), and those who consume < 50% will be considered inadequate (50%).
International Physical Activity Questionnaire (IPAQ- Short Form)
Time frame: up to 10 months
It was developed by Craig et al. to determine the physical activity status of individuals (Craig et al., 2003). It is a 7-question form whose Turkish validity and reliability was performed by Öztürk (Öztürk, 2005). In this form in which walking, moderate activity, vigorous activity and time spent sitting are questioned, weekly MET values of individuals are calculated and individuals are classified as inactive, minimally active and very active according to the results. A score is obtained as "MET/min/week" by multiplying the minutes, days and MET values of the physical activity performed. In the calculation of the walking score, a walking time of 3.3 METs, 4 METs for moderate physical activity and 8 METs for vigorous physical activity are accepted. If the calculated value is 3000 MET/min/week, it is classified as very active
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 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.
Murat URHAN, PhD principal investigator
Ege University
Ezgi KARATAŞ, PhD principal investigator
Ege University
Rana N AKDER, Msc principal investigator
Ege 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 and nutritional status, eating habits in people with Nutrition, Healthy and Nutrition Disorders in Adolescence, run by Ege 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Feb 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özge KÜÇÜKERDÖNMEZ, PhD (05352769596, dytozgek@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nutrition literacy (time frame: up to 10 months). The study lists 7 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 23 Feb 2024.