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Childhood ObesityNCT07168928

School-Based Nutrition Education in Primary Students

A study testing School-Based Nutrition Education Program in people with Childhood Obesity and School-Aged Children, run by Çağlar Akçalı at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the effects of a school-based nutrition education program and the implementation of a school dietitian model on primary school students in Mardin, Türkiye. A total of 67 fourth-grade students were randomized into intervention (n=32) and control (n=35) groups. Read more about this study

Who is it for?
Ages 10 to 11 yearsHealthy volunteers can take part
What is being tested?
School-Based Nutrition Education Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2024to 30 Apr 2025
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 10 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Enrolled as a fourth-grade student in the selected primary school in Mardin, Türkiye.
  • Aged between 10 and 11 years.
  • Able to participate in classroom-based activities and complete the study assessments.
  • Obtained written informed consent from parents.

Who cannot join

  • Students with physical or cognitive impairments that prevent participation in educational sessions or completion of questionnaires.
  • Absence from school during the intervention period that would preclude participation in the majority of sessions.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Mardin Artuklu University

    Mardin, Artuklu, 47200

Other trials in Turkey (Türkiye)

About this study

Official title: School-Based Nutrition Education and School Dietitian Model in Primary School Students: A Randomised Controlled Trial

This study aims to evaluate the effects of a school-based nutrition education program and the implementation of a school dietitian model on primary school students in Mardin, Türkiye. A total of 67 fourth-grade students were randomized into intervention (n=32) and control (n=35) groups. The intervention group received an eight-week classroom-based nutrition education program, while their parents received four weeks of parent-focused education. Outcomes were measured using the Nutrition Knowledge Test, Nutrition Attitude Scale, Nutrition Behavior Scale, Child Physical Activity Questionnaire, and anthropometric assessments including weight, height, BMI, and waist circumference. The study seeks to determine whether dietitian-led school-based nutrition education can improve children's nutrition knowledge, attitudes, and behaviours, as well as influence anthropometric measures. Findings from this trial are expected to inform future strategies for integrating school dietitians and structured nutrition education into primary schools in Türkiye.

Read the detailed description

Childhood obesity and malnutrition are urgent public health challenges in Türkiye, particularly in regions with limited access to structured health promotion programmes. Schools represent an appropriate setting for preventive strategies as they provide consistent opportunities for health education and behaviour reinforcement.

Study Design and Randomisation This study was designed as a single-centre, parallel-group, randomised controlled trial (RCT) conducted in a public primary school in Mardin, Türkiye. A total of 70 fourth-grade students were recruited and randomly allocated into intervention and control groups using a simple randomisation procedure performed by an independent researcher. Allocation was concealed until group assignments were finalised.

Intervention The intervention group participated in an eight-week school-based nutrition education programme, led by a registered dietitian, with one session delivered per week during school hours. Each session lasted approximately 40 minutes and included structured modules on food groups, balanced diet, healthy snacking, and the risks of processed foods. Interactive teaching methods such as educational games, puzzles, and visual aids were applied to increase engagement. In parallel, parents of the intervention group students attended a four-week supplementary programme delivered in evening sessions, covering home-based nutrition practices and strategies for supporting healthy child eating behaviours.

The control group continued routine school activities during the study period. To ensure equity, they were provided with an abridged version of the nutrition education materials after study completion.

Data Collection Procedures Measurements were performed at three time points: baseline (T0), immediately after the intervention (T1), and two months post-intervention (T2). Trained assessors, blinded to group allocation, collected data following standardised protocols.

Instruments used included:

  • Nutrition Knowledge Test (NKT)
  • Nutrition Attitude Scale (NAS)
  • Nutrition Behaviour Scale (NBS)
  • Child Physical Activity Questionnaire (CPAQ)

Anthropometric data (height, weight, waist circumference, and BMI) were measured using calibrated equipment under uniform conditions.

Outcomes and Analysis Primary outcomes included changes in nutrition knowledge, attitudes, and behaviours, as well as physical activity levels. Secondary outcomes focused on anthropometric indicators and dietary habits. Data were analysed using intention-to-treat principles. Continuous variables were evaluated with repeated measures ANOVA to detect changes across the three assessment points, while categorical variables were tested with chi-square statistics. A p-value <0.05 was considered statistically significant.

Ethical and Quality Considerations Ethical approval was obtained from the institutional review board, and written informed consent was secured from parents alongside child assent. Confidentiality was maintained by anonymising data, and all educational materials were standardised to ensure consistency in intervention delivery.

Significance By providing a structured description of the intervention design and evaluation process, this study aims to generate evidence for the effectiveness of integrating school dietitians into the Turkish primary education system. The results will inform national strategies targeting childhood obesity prevention and promote sustainable health policies.

Being tested
School-Based Nutrition Education Program
Keywords
School-based nutrition education, school-aged children, nutrition knowledge, school dietitian, anthropometric measurements
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • School-Based Nutrition Education ProgramBehavioural

    The intervention consisted of an eight-week, school-based nutrition education programme delivered to fourth-grade students by a school dietitian. Sessions were conducted once per week and included interactive lectures, games, and educational activities focusing on healthy eating, food groups, balanced meals, and the risks of processed food consumption. In addition, parents of students in the intervention group received a four-week educational programme on child nutrition, meal planning, and healthy lifestyle practices.

Study groups in NCT07168928
Study groupRoleWhat they receive
Intervention Group - School-Based Nutrition EducationExperimentalStudents in this group participated in an eight-week, classroom-based nutrition education programme led by a school dietitian. The sessions were interactive and age-appropriate, focusing on healthy eating, food groups, meal planning, and the risks of processed foods. In addition, parents received a four-week educational programme on child nutrition and healthy dietary practices.
Receives: Behavioral: School-Based Nutrition Education Program
Control Group - Routine School ActivitiesNo interventionStudents in this group continued with their routine school curriculum without receiving additional nutrition education during the intervention period. After the study was completed, control group students were provided access to the nutrition education materials.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nutrition Knowledge Score

    In order to evaluate the nutritional behaviours, knowledge level and attitudes of the students, questions prepared by making use of the literature and in parallel with the nutrition education given were used. In the evaluation, +1 point was given for each correct answer, 0 points for each incorrect answer, and the total score was reported. Higher scores obtained from the test indicate higher nutritional knowledge.

    Measured: Baseline, immediately post-intervention (8 weeks), and 2-month follow-up.

  2. Nutrition Attitude Score

    The scale consists of exercise, nutrition, smoking and stress control sub-dimensions. In this study, only the 'nutrition' sub-dimension was used. The overall internal consistency coefficient of the scale was reported as 0.79 and the internal consistency coefficient of the nutrition subscale was reported as 0.68. The nutrition sub-dimension assesses the child's attitude towards behaviours to reduce fat intake, increase healthy food consumption and diets that support heart health. Scale items are scored between 1 (strongly disagree) and 4 (strongly agree) and the total score ranges from 4 to 16. The high scores obtained reflect favourable nutritional attitudes.

    Measured: Baseline, immediately post-intervention (8 weeks), and 2-month follow-up.

  3. Nutrition Behaviour Score

    It was developed to determine children's food preferences. It consists of 14 items featuring images of healthy and unhealthy foods. On the scale, each unhealthy food choice is assigned -1 point, each healthy food choice is assigned +1 point, and the total score ranges from -14 to +14. High scores indicate healthy eating habits.

    Measured: Baseline, immediately post-intervention (8 weeks), and 2-month follow-up.

Secondary outcomes (3)
  1. Body Mass Index (BMI)

    Change in BMI (kg/m²) calculated from measured height and weight of participants. This will assess the effect of the nutrition education programme on growth and weight status.

    Measured: Baseline, immediately post-intervention (8 weeks), and 2-month follow-up.

  2. Waist Circumference

    Change in waist circumference (cm) measured using a standard anthropometric tape at the midpoint between the lower rib and iliac crest. This will evaluate central adiposity changes following the intervention.

    Measured: Baseline, immediately post-intervention (8 weeks), and 2-month follow-up.

  3. Physical Activity Score

    The questionnaire was used to determine the physical activity levels of the students. The Cronbach's alpha coefficient as 0.86. CPAQ was developed to assess the physical activity levels of children aged 8-14 years. The form is filled in by the child. The form consists of 10 questions and the physical activity status of the child in the last seven days is questioned with the form. Except for the question questioning the disease status of the questionnaire, each item is evaluated as 5 points and an activity score between 1-5 is found. '1' indicates low physical activity and '5' indicates high physical activity.

    Measured: Baseline, immediately post-intervention (8 weeks), and 2-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study start1 Nov 2024
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

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
Model description
This study used a randomized, parallel assignment design. Fourth-grade primary school students were randomly allocated to either an intervention group or a control group. The intervention group received an eight-week classroom-based nutrition education program led by dietitians, while their parents participated in a four-week parent-focused education program. The control group continued with routine school activities without additional nutrition education during the study period. Data were collected at baseline, immediately after the intervention, and at a two-month follow-up for the intervention group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07168928
Sponsor's protocol ID
2024-7
Status last verified
Sep 2025
First submitted
4 Sep 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to privacy concerns and ethical considerations related to the small sample size, which may increase the risk of participant identification

Publications

  • Erdim L, Ergun A, Kuguoglu S. Reliability and validity of the Turkish version of the Physical Activity Questionnaire for Older Children (PAQ-C). Turk J Med Sci. 2019 Feb 11;49(1):162-169. doi: 10.3906/sag-1806-212.

    PubMed 30764593
  • Kowalski KC, Crocker PRE, Faulkner RA. Validation of the physical activity questionnaire for older children. Pediatr Exerc Sci. 1997;9(2):174-186.

  • Crocker PR, Bailey DA, Faulkner RA, Kowalski KC, McGrath R. Measuring general levels of physical activity: preliminary evidence for the Physical Activity Questionnaire for Older Children. Med Sci Sports Exerc. 1997 Oct;29(10):1344-9. doi: 10.1097/00005768-199710000-00011.

    PubMed 9346166
  • Edmundson E, Parcel GS, Perry CL, Feldman HA, Smyth M, Johnson CC, Layman A, Bachman K, Perkins T, Smith K, Stone E. The effects of the child and adolescent trial for cardiovascular health intervention on psychosocial determinants of cardiovascular disease risk behavior among third-grade students. Am J Health Promot. 1996 Jan-Feb;10(3):217-25. doi: 10.4278/0890-1171-10.3.217.

    PubMed 10163302
  • Haney MÖ, Bahar Z. Çocuk kalp sağlığını geliştirme tutum ölçeği'nin geçerlik ve güvenirliği. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi. 2014;7(2):92-97.

  • Arvidson CR. Children's Cardiovascular Health Promotion Attitude Scale: An Instrument Development. Texas Woman's University; 1990

  • Akcali C, Karadas H, Ayhanci NN. Dietitian-led school-based nutrition education and its effects on knowledge, attitudes, behaviours and anthropometric measurements: a randomized controlled trial. BMC Public Health. 2026 Feb 9;26(1):1152. doi: 10.1186/s12889-026-26194-x.

    PubMed 41664077

Questions about this trial

What is this clinical trial studying?

A study testing School-Based Nutrition Education Program in people with Childhood Obesity and School-Aged Children, run by Çağlar Akçalı 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 4 inclusion and 2 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 19 Sep 2025. 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?

Nutrition Knowledge Score (time frame: Baseline, immediately post-intervention (8 weeks), and 2-month follow-up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07168928, which also lists 7 linked publications.

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 19 Sep 2025.

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