- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07761559
Effect of a Nutrition Education Intervention on Ultra-Processed Food Awareness and Consumption Among University Students
Tıp Fakültesi Öğrencilerinde "Besinini Bilinçli Tüket, Sağlığı Seç" Eğitim Programının Ultra İşlenmiş Gıda Farkındalığına Etkisinin Değerlendirilmesi: Yarı Deneysel Kontrollü Çalışma
Ultra-processed foods are industrially formulated products that often contain high amounts of salt, sugar, and saturated fat, as well as additives. Higher consumption of these foods has been associated with several chronic diseases. Medical students may be at increased risk of unhealthy dietary behaviors and food insecurity.
This study aims to evaluate the effects of a low-cost nutrition education program on medical students' knowledge and attitudes about ultra-processed foods, ultra-processed food consumption, nutrition label literacy, and nutrition self-efficacy.
A total of 74 sixth-year medical students at Eskisehir Osmangazi University Faculty of Medicine will be assigned by clusters to either an intervention group or a control group. The intervention group will participate in an educational program about ultra-processed foods, food labels, and healthier food choices. The control group will not receive this educational program during the study period.
Data will be collected at baseline, immediately after the intervention, and at the one-month follow-up. The study will assess food security, knowledge and attitudes regarding ultra-processed foods, ultra-processed food consumption, nutrition label literacy, nutrition self-efficacy, and dietary intake based on three-day food records.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is designed as a cluster-randomized controlled intervention study with pre-intervention, post-intervention, and one-month follow-up measurements. The study will be conducted among sixth-year medical students at Eskisehir Osmangazi University Faculty of Medicine. Students aged 18 years or older who understand Turkish, agree to participate, and provide informed consent will be eligible.
Internship groups will be assigned as clusters to either the intervention group or the control group. All eligible students in the selected internship groups will be invited to participate. The sample size calculation indicated that at least 34 participants per group are required. To account for possible losses during follow-up, the target sample size was increased by 10%. The final number of participants may vary depending on the number of eligible and consenting students in the selected clusters.
The intervention group will receive a structured nutrition education program, while the control group will not receive this program during the study period. The education program is based on the Health Belief Model and Social Cognitive Theory. It focuses on ultra-processed foods, the NOVA food classification system, associations between ultra-processed food consumption and chronic diseases, nutrition label literacy, food security, nutrition self-efficacy, and healthier food choices.
The program includes lectures, small-group discussions, interactive quizzes, case-based learning, role-playing, food-label exercises, analysis of dietary records, low-cost meal planning, and practical cooking activities. Participants will learn to distinguish ultra-processed foods from minimally processed and processed foods, interpret ingredient lists and nutrition information, evaluate the contribution of ultra-processed foods to dietary energy and nutrient intake, and establish achievable personal goals for reducing ultra-processed food consumption.
Data will be collected at baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2). The assessment includes sociodemographic characteristics and health behaviors, food security, knowledge and attitudes concerning ultra-processed foods, food-processing knowledge, ultra-processed food consumption, nutrition label literacy, nutrition self-efficacy, and three-day dietary records.
Changes in outcomes over time will be compared between the intervention and control groups to determine whether the education program improves knowledge, attitudes, nutrition label literacy, and nutrition self-efficacy and reduces ultra-processed food consumption.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Eskişehir
-
Eskişehir, Eskişehir, Turquía (Türkiye), 26040
- Eskisehir Osmangazi University Faculty of Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Agreeing to participate in the study
- Being a medical faculty student
- Being able to understand Turkish
- Being 18 years of age or older
Exclusion Criteria:
- Not agreeing to participate in the study
- Not being a medical faculty student
- Being unable to understand Turkish
- Being under 18 years of age
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Nutrition Education Intervention
Participants in this arm will receive a structured nutrition education program focusing on ultra-processed foods, nutrition label literacy, food insecurity, nutrition self-efficacy, and healthier food choices.
Measurements will be conducted before the intervention, immediately after the intervention, and at the one-month follow-up.
|
The multi-session nutrition education program is planned and implemented based on the PRECEDE-PROCEED Model.
During the PRECEDE phase, problems related to ultra-processed food consumption and food insecurity among medical students are analyzed, and predisposing, enabling, and reinforcing factors are identified.
The intervention content is structured to address these determinants.
During the PROCEED phase, the education program is implemented, and its effects on participants' knowledge, attitudes, and behaviors are evaluated.
The intervention is also informed by the Health Belief Model and Social Cognitive Theory.
The program covers ultra-processed foods, the NOVA food classification system, associations between ultra-processed food consumption and chronic diseases, nutrition label reading, front-of-pack nutrition labels, food insecurity, nutrition self-efficacy, and healthier food choices.
It includes presentations, small-group discussions, interactive quizzes, case-based learning, rol
|
|
Sin intervención: Control Group
Participants in this arm will not receive the structured nutrition education program during the study period.
Measurements will be conducted at baseline, immediately after the intervention period, and at the one-month follow-up
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Ultra-Processed Food Consumption
Periodo de tiempo: Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
Ultra-processed food consumption will be assessed using the Turkish version of the Short Screening Questionnaire for Highly Processed Food Consumption (sQ-HPF).
The total score ranges from 0 to 11, with higher scores indicating higher consumption of ultra-processed foods.
Scores of 6 or above indicate a high level of ultra-processed food consumption.
|
Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
|
Change in Ultra-Processed Food Knowledge
Periodo de tiempo: Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
Knowledge of ultra-processed foods will be assessed using a list of 20 foods, including 10 ultra-processed and 10 non-ultra-processed foods.
Participants will classify each food according to whether it is ultra-processed.
One point will be awarded for each correct classification.
The total score ranges from 0 to 20, with higher scores indicating greater accuracy in identifying ultra-processed foods.
|
Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Food Processing Knowledge
Periodo de tiempo: Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
Food processing knowledge will be assessed using the Food Processing Knowledge Score (FoodProK).
The assessment includes 12 foods from four categories: fruits, meat products, dairy products, and grains.
Each category includes foods representing NOVA Groups 1, 3, and 4. Participants rank the foods according to perceived healthiness.
Each category is scored from 0 to 2 according to agreement with the expected NOVA-based ranking.
The total score ranges from 0 to 8, with higher scores indicating greater knowledge of food processing levels.
|
Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
|
Change in Nutrition Label Literacy
Periodo de tiempo: Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
Nutrition label literacy will be assessed using the 10-item Evaluation and Application of Label Information subscale of the Food Label Literacy Scale.
Items are scored on a 5-point Likert scale ranging from 1 (very difficult) to 5 (very easy).
Higher scores indicate greater nutrition label literacy.
|
Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
|
Change in Nutrition Self-Efficacy
Periodo de tiempo: Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
Nutrition self-efficacy will be assessed using the five-item Nutrition Self-Efficacy Scale.
Each item is scored on a 4-point Likert scale ranging from 1 (not at all certain) to 4 (very certain).
No items are reverse-scored.
The total score ranges from 5 to 20, with higher scores indicating greater nutrition self-efficacy.
|
Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
|
Change in the Acceptability of Front-of-Pack Nutrition Labels
Periodo de tiempo: Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
The acceptability of front-of-pack nutrition labels will be assessed using five items adapted from previous studies.
Each item is scored on a 5-point Likert scale.
The mean score of the five items will be calculated, with higher mean scores indicating greater acceptability of front-of-pack nutrition labels.
|
Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
|
Change in Purchase Intention for Products With Front-of-Pack Nutrition Labels
Periodo de tiempo: Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
Purchase intention for products displaying front-of-pack nutrition labels will be assessed using one item scored on a 5-point Likert scale.
|
Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
|
Change in Views About Front-of-Pack Nutrition Labels
Periodo de tiempo: Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
Participants' views about front-of-pack nutrition labels will be assessed using three items adapted from previous studies.
Each item is scored on a 5-point Likert scale.
|
Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
|
Change in Dietary Intake Based on Three-Day Food Records
Periodo de tiempo: Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
Dietary intake will be assessed using three-day food records completed by the participants.
The records will cover two weekdays and one weekend day, with all foods and beverages consumed during each 24-hour period recorded by the participants.
|
Baseline before the intervention (T0), immediately after the intervention (T1), and at the one-month follow-up (T2)
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- E-25403353-050.04-260051004
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .