An interventional study of Structured Nutrition Counseling and Standard Care in Gestational Diabetes Mellitus and Pregnancy, sponsored by Istanbul Saglik Bilimleri University. Not yet recruiting. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Istanbul Saglik Bilimleri University · Not applicable, Interventional, and Supportive care
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.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's planned enrollment of 48 is below the median of 110 across 564 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Istanbul Saglik Bilimleri University is the lead sponsor of 60 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women with normal glucose tolerance receiving standard obstetric care and routine dietitian consultation.
Other: Standard Care
Pregnant women with normal glucose tolerance receiving standard obstetric care plus structured nutrition counseling.
Behavioral: Structured Nutrition Counseling · Other: Standard Care
Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management and routine dietitian consultation.
Other: Standard Care
Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management plus structured nutrition counseling.
Behavioral: Structured Nutrition Counseling · Other: Standard Care
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 obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
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
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
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
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
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
Birth Weight
Infant birth weight will be recorded in grams after delivery from obstetric and neonatal records.
Time frame: At delivery
Gestational Age at Birth
Gestational age at birth will be recorded in completed weeks after delivery from obstetric records.
Time frame: At delivery
Congenital Anomaly Status
The presence or absence of congenital anomaly will be recorded after delivery from obstetric and neonatal records.
Time frame: At delivery
No study locations are listed for this record.
Plan to share: No — 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.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Istanbul Saglik Bilimleri University