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Nutrition Counseling, Diet Quality, and Advanced Glycation End Products in Gestational Diabetes

8. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: NGT-Control
Pregnant women with normal glucose tolerance receiving standard obstetric care and routine dietitian consultation.
Andet: Standard Care
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
Eksperimentel: NGT-Intervention
Pregnant women with normal glucose tolerance receiving standard obstetric care plus structured nutrition counseling.
Andet: Standard Care
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
Adfærdsmæssigt: Structured Nutrition Counseling
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.
Aktiv komparator: GDM-Control
Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management and routine dietitian consultation.
Andet: Standard Care
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
Eksperimentel: GDM-Intervention
Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management plus structured nutrition counseling.
Andet: Standard Care
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
Adfærdsmæssigt: Structured Nutrition Counseling
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diet Quality Score
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Highly Processed Food Consumption Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At delivery
Infant birth weight will be recorded in grams after delivery from obstetric and neonatal records.
At delivery
Gestational Age at Birth
Tidsramme: At delivery
Gestational age at birth will be recorded in completed weeks after delivery from obstetric records.
At delivery
Congenital Anomaly Status
Tidsramme: At delivery
The presence or absence of congenital anomaly will be recorded after delivery from obstetric and neonatal records.
At delivery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul Saglik Bilimleri University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-49

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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