Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06275802
Other study ID # 22-5.1T/2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 6, 2022
Est. completion date June 30, 2024

Study information

Verified date February 2024
Source Ege University
Contact Özge KÜÇÜKERDÖNMEZ, PhD
Phone 05352769596
Email dytozgek@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date June 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - studying in the 9th and 10th grades in the selected schools - agree to participate in the research Exclusion Criteria: - 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

Study Design


Intervention

Behavioral:
Nutrition Education
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 habits
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

Locations

Country Name City State
Turkey Menemen District Directorate of National Education Izmir

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 10 months
Primary 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). up to 10 months
Primary 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. up to 10 months
Primary 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.
up to 10 months
Primary 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. up to 10 months
Primary 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%). up to 10 months
Primary 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 up to 10 months
See also
  Status Clinical Trial Phase
Completed NCT03117374 - Impact of Web-based School Nutrition Intervention to Increase Fruits, Vegetables and Dairy N/A
Completed NCT04025099 - Internal Cues Versus External Cues for Eating and Activity N/A
Recruiting NCT06111040 - Nurturing Needs Study: Parenting Food Motivated Children N/A
Completed NCT05485168 - Combined Effects of Sequential Variety and Portion Size on Meal Intake of Women N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT03850990 - Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss N/A
Completed NCT02470949 - Influence of a Monopoly Game on Subtle Behaviors N/A
Recruiting NCT01863212 - The Role of the FTO Gene in Reward System Activation in Obese and Healthy Subjects N/A
Completed NCT02729675 - Innovative Approaches to Increase F&V Intake Thru Worksites Phase 2
Completed NCT05405244 - Examination of Bromocriptine on Homeostatic and Hedonic Mechanisms of Food Intake in Individuals at High Risk for T2DM Phase 3
Completed NCT04971811 - Effects of Energy Density on Self-served Snacks in Preschool Children N/A
Completed NCT05019872 - Al Dente or Well Done? The Eating Rate of a Pasta Meal Modified by Texture N/A
Completed NCT04605224 - Effectiveness of a Culinary Class on Food Literacy and Eating Behaviours of Francophone High School Students
Not yet recruiting NCT06448117 - Mind Nutrition Study: Nutrition in the Prevention of Depressiveness and Sustaining Work Ability N/A
Recruiting NCT04526743 - Eating Behavior and Weight Trajectory After Bariatric Surgery
Active, not recruiting NCT05026411 - Food Reward Circuit Change by Orthodontics N/A
Completed NCT05173311 - Pilot Study: The Effectiveness of a Mobile Application in Increasing Vegetable Acceptance N/A
Completed NCT05149066 - #KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents N/A
Completed NCT03779321 - Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects N/A
Recruiting NCT06108128 - Food for Thought: Executive Functioning Around Eating Among Children N/A