NCT06275802

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 6, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

January 18, 2023

Last Update Submit

February 16, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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.

Behavioral: Nutrition EducationBehavioral: 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

Behavioral: nutritional status, eating habits

Interventions

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).

Intervention schools (educated about nutrition)

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

Control schools (non-educated about nutrition)Intervention schools (educated about nutrition)

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • studying in the 9th and 10th grades in the selected schools
  • agree to participate in the research

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menemen District Directorate of National Education

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Interventions

Nutrition AssessmentNutritional Status

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Murat URHAN, PhD

    Ege University

    PRINCIPAL INVESTIGATOR
  • Ezgi KARATAŞ, PhD

    Ege University

    PRINCIPAL INVESTIGATOR
  • Rana N AKDER, Msc

    Ege University

    PRINCIPAL INVESTIGATOR
  • Ceren AKANALÇI, Msc

    Ege University

    PRINCIPAL INVESTIGATOR
  • Reci MESERİ, PhD

    Ege University

    PRINCIPAL INVESTIGATOR
  • Özge KÜÇÜKERDÖNMEZ, PhD

    Ege University

    STUDY DIRECTOR

Central Study Contacts

Özge KÜÇÜKERDÖNMEZ, PhD

CONTACT

Reci MESERİ, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 18, 2023

First Posted

February 23, 2024

Study Start

June 6, 2022

Primary Completion

December 30, 2023

Study Completion

June 30, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations