Nutrition Counseling, Diet Quality, and Advanced Glycation End Products in Gestational Diabetes
8 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
48
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: BEYZANUR ÇAMLIBEL, Dietitian / PhD Candidate
- Telefoonnummer: +90 541 656 78 19
- E-mail: beyzanur.cmlbl@gmail.com
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
|
|
Experimenteel: 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.
|
|
Actieve vergelijker: 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.
|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Diet Quality Score
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Highly Processed Food Consumption Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: At delivery
|
Infant birth weight will be recorded in grams after delivery from obstetric and neonatal records.
|
At delivery
|
|
Gestational Age at Birth
Tijdsspanne: At delivery
|
Gestational age at birth will be recorded in completed weeks after delivery from obstetric records.
|
At delivery
|
|
Congenital Anomaly Status
Tijdsspanne: At delivery
|
The presence or absence of congenital anomaly will be recorded after delivery from obstetric and neonatal records.
|
At delivery
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 augustus 2026
Primaire voltooiing (Geschat)
1 mei 2027
Studie voltooiing (Geschat)
1 juli 2027
Studieregistratiedata
Eerst ingediend
3 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
8 juni 2026
Eerst geplaatst (Werkelijk)
9 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
8 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Endocriene systeemziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Metabole ziekten
- Zwangerschap Complicaties
- Glucosemetabolismestoornissen
- Suikerziekte
- Gedrag
- Voedings- en stofwisselingsziekten
- Gedrag, dier
- Diabetes, zwangerschap
- Voedingsgedrag
- Health Services Administration
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Kwaliteitsindicatoren, gezondheidszorg
- Zorgstandaard
Andere studie-ID-nummers
- 25-49
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .