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

8. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

48

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: NGT-Control
Pregnant women with normal glucose tolerance receiving standard obstetric care and routine dietitian consultation.
Annen: Standard Care
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
Eksperimentell: NGT-Intervention
Pregnant women with normal glucose tolerance receiving standard obstetric care plus structured nutrition counseling.
Annen: Standard Care
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
Atferdsmessig: 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.
Annen: Standard Care
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
Eksperimentell: GDM-Intervention
Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management plus structured nutrition counseling.
Annen: Standard Care
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Istanbul Saglik Bilimleri University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

3. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25-49

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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