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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorIstanbul Saglik Bilimleri University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Current use of insulin therapy

Active smoking

Alcohol use

Refusal or inability to provide written informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: NGT-ControlActive comparator 1 intervention
Group B: NGT-InterventionExperimental treatment 2 interventions
Group C: GDM-ControlActive comparator 1 intervention
Group D: GDM-InterventionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Diet Quality Score

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.

Time frame
Baseline at 24-28 weeks of gestation and final assessment at 32-36 weeks of gestation
2

Serum Advanced Glycation End Products Level

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.

Time frame
Final assessment at approximately 32-36 weeks of gestation

Secondary outcomes

1

Highly Processed Food Consumption Score

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.

Time frame
Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
2

Dietary Habits and Cooking Methods

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.

Time frame
Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
3

Gestational Weight Gain

Gestational weight gain will be evaluated using maternal body weight measurements recorded during pregnancy follow-up.

Time frame
Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation
4

Birth Weight

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

Time frame
At delivery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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