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

June 8, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NGT-Control
Pregnant women with normal glucose tolerance receiving standard obstetric care and routine dietitian consultation.
Other: Standard Care
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.
Other: Standard Care
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
Behavioral: 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.
Active Comparator: GDM-Control
Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management and routine dietitian consultation.
Other: Standard Care
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.
Other: Standard Care
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diet Quality Score
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Saglik Bilimleri University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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