Nutrition Counseling, Diet Quality, and Advanced Glycation End Products in Gestational Diabetes
8 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
48
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: BEYZANUR ÇAMLIBEL, Dietitian / PhD Candidate
- Numéro de téléphone: +90 541 656 78 19
- E-mail: beyzanur.cmlbl@gmail.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diet Quality Score
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Highly Processed Food Consumption Score
Délai: 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
Délai: 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
Délai: 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
Délai: At delivery
|
Infant birth weight will be recorded in grams after delivery from obstetric and neonatal records.
|
At delivery
|
|
Gestational Age at Birth
Délai: At delivery
|
Gestational age at birth will be recorded in completed weeks after delivery from obstetric records.
|
At delivery
|
|
Congenital Anomaly Status
Délai: At delivery
|
The presence or absence of congenital anomaly will be recorded after delivery from obstetric and neonatal records.
|
At delivery
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
1 mai 2027
Achèvement de l'étude (Estimé)
1 juillet 2027
Dates d'inscription aux études
Première soumission
3 juin 2026
Première soumission répondant aux critères de contrôle qualité
8 juin 2026
Première publication (Réel)
9 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies du système endocrinien
- Maladies urogénitales féminines et complications de la grossesse
- Maladies métaboliques
- Complications de grossesse
- Troubles du métabolisme du glucose
- Diabète sucré
- Comportement
- Maladies nutritionnelles et métaboliques
- Comportement, animal
- Diabète gestationnel
- Comportement alimentaire
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Qualité des soins de santé
- Indicateurs de qualité, soins de santé
- Standard de soins
Autres numéros d'identification d'étude
- 25-49
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .