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NCT Number: NCT07636577

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus Behavior Behavior, Animal Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Pregnancy Complications Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Nutrition Counseling

Behavioral

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.

Standard care

Other

Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Birth Weight

    Time frame: At delivery

    Infant birth weight will be recorded in grams after delivery from obstetric and neonatal records.

  5. Gestational Age at Birth

    Time frame: At delivery

    Gestational age at birth will be recorded in completed weeks after delivery from obstetric records.

  6. Congenital Anomaly Status

    Time frame: At delivery

    The presence or absence of congenital anomaly will be recorded after delivery from obstetric and neonatal records.

Study contacts

Contact information is provided by the study sponsor or research team.

BEYZANUR ÇAMLIBEL, Dietitian / PhD Candidate

CONTACT

[email protected]

+90 541 656 78 19

Sponsors and collaborators

Lead sponsor

Istanbul Saglik Bilimleri University

Other

Registry information

Official study title

The Relationship Between Nutrition Counseling in Gestational Diabetes Mellitus and Diet Quality and Advanced Glycation End Products

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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