Nutrition Counseling, Diet Quality, and Advanced Glycation End Products in Gestational Diabetes
8 de junio de 2026 actualizado por: Beyzanur Çamlıbel, Istanbul Saglik Bilimleri University
The Relationship Between Nutrition Counseling in Gestational Diabetes Mellitus and Diet Quality and Advanced Glycation End Products
This study will evaluate the relationship between structured nutrition counseling, diet quality, and advanced glycation end products in pregnant women with gestational diabetes mellitus and women with normal glucose tolerance.
Participants will be assigned to either a structured nutrition counseling group or a standard care group according to glucose tolerance status.
The counseling program will include education and follow-up on healthy eating during pregnancy, gestational diabetes management, portion control, food choices, meal planning, and cooking methods.
Diet quality, dietary habits, biochemical parameters, advanced glycation end products, gestational weight gain, and fetal outcomes will be assessed during follow-up.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
48
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: BEYZANUR ÇAMLIBEL, Dietitian / PhD Candidate
- Número de teléfono: +90 541 656 78 19
- Correo electrónico: beyzanur.cmlbl@gmail.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Pregnant women aged 18 to 35 years
- Singleton and first pregnancy
- Gestational age between 24 and 28 weeks at enrollment
- Diagnosis of gestational diabetes mellitus or normal glucose tolerance
- Not using insulin therapy
- Stopped smoking at least 3 months before enrollment and not using alcohol
- Willingness to participate in the study
- Ability to provide written informed consent
Exclusion Criteria:
- Current use of insulin therapy
- Active smoking
- Alcohol use
- Refusal or inability to provide written informed consent
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: NGT-Control
Pregnant women with normal glucose tolerance receiving standard obstetric care and routine dietitian consultation.
|
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
|
|
Experimental: NGT-Intervention
Pregnant women with normal glucose tolerance receiving standard obstetric care plus structured nutrition counseling.
|
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
A dietitian-led structured nutrition counseling, education, and follow-up program provided in addition to standard care.
The program includes education on pregnancy, gestational diabetes mellitus, adequate and balanced nutrition, appropriate gestational weight gain, portion control, low glycemic index food choices, reduction of highly processed foods, healthy cooking methods, carbohydrate intake, and meal planning.
Follow-up will be conducted at least every two weeks by telephone, online, or face-to-face sessions.
Dietary records and weight changes will be reviewed, and individualized feedback and motivational support will be provided.
|
|
Comparador activo: GDM-Control
Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management and routine dietitian consultation.
|
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
|
|
Experimental: GDM-Intervention
Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management plus structured nutrition counseling.
|
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
A dietitian-led structured nutrition counseling, education, and follow-up program provided in addition to standard care.
The program includes education on pregnancy, gestational diabetes mellitus, adequate and balanced nutrition, appropriate gestational weight gain, portion control, low glycemic index food choices, reduction of highly processed foods, healthy cooking methods, carbohydrate intake, and meal planning.
Follow-up will be conducted at least every two weeks by telephone, online, or face-to-face sessions.
Dietary records and weight changes will be reviewed, and individualized feedback and motivational support will be provided.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diet Quality Score
Periodo de tiempo: Baseline at 24-28 weeks of gestation and final assessment at 32-36 weeks of gestation
|
Diet quality will be assessed using the Diet Quality Index-International based on three-day food records.
The score ranges from 0 to 100, with higher scores indicating better diet quality.
|
Baseline at 24-28 weeks of gestation and final assessment at 32-36 weeks of gestation
|
|
Serum Advanced Glycation End Products Level
Periodo de tiempo: Final assessment at approximately 32-36 weeks of gestation
|
Serum advanced glycation end products levels will be measured using serum samples obtained from residual blood collected during routine clinical tests.
Levels will be evaluated in relation to glucose tolerance status, nutrition counseling, diet quality, and dietary behaviors.
|
Final assessment at approximately 32-36 weeks of gestation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Highly Processed Food Consumption Score
Periodo de tiempo: Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
|
Highly processed food consumption will be assessed using the short screening questionnaire of highly processed food consumption.
Higher scores indicate higher consumption of highly processed foods.
|
Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
|
|
Dietary Habits and Cooking Methods
Periodo de tiempo: Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
|
Dietary habits and cooking methods will be assessed using a structured questionnaire including meal frequency, skipped meals, snacking habits, food preferences, cooking methods, and types of oils used in food preparation.
|
Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
|
|
Gestational Weight Gain
Periodo de tiempo: Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
|
Gestational weight gain will be evaluated using maternal body weight measurements recorded during pregnancy follow-up.
|
Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
|
|
Birth Weight
Periodo de tiempo: At delivery
|
Infant birth weight will be recorded in grams after delivery from obstetric and neonatal records.
|
At delivery
|
|
Gestational Age at Birth
Periodo de tiempo: At delivery
|
Gestational age at birth will be recorded in completed weeks after delivery from obstetric records.
|
At delivery
|
|
Congenital Anomaly Status
Periodo de tiempo: At delivery
|
The presence or absence of congenital anomaly will be recorded after delivery from obstetric and neonatal records.
|
At delivery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de mayo de 2027
Finalización del estudio (Estimado)
1 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
3 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de junio de 2026
Publicado por primera vez (Actual)
9 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades del sistema endocrino
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades metabólicas
- Complicaciones del embarazo
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Comportamiento, animal
- Diabetes Gestacional
- Comportamiento de alimentación
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- 25-49
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared because the study includes sensitive health data from pregnant women.
Data will be stored and analyzed in coded and anonymized form in accordance with the informed consent and ethics committee approval.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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