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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGT-Control | Active Comparator | Pregnant women with normal glucose tolerance receiving standard obstetric care and routine dietitian consultation. |
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| NGT-Intervention | Experimental | Pregnant women with normal glucose tolerance receiving standard obstetric care plus structured nutrition counseling. |
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| GDM-Control | Active Comparator | Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management and routine dietitian consultation. |
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| GDM-Intervention | Experimental | Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management plus structured nutrition counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Final assessment at approximately 32-36 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility is limited to pregnant women because the study focuses on gestational diabetes mellitus and pregnancy-related nutritional and metabolic outcomes.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BEYZANUR ÇAMLIBEL, Dietitian / PhD Candidate | Contact | +90 541 656 78 19 | beyzanur.cmlbl@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33085688 | Result | Sisay M, Edessa D, Ali T, Mekuria AN, Gebrie A. The relationship between advanced glycation end products and gestational diabetes: A systematic review and meta-analysis. PLoS One. 2020 Oct 21;15(10):e0240382. doi: 10.1371/journal.pone.0240382. eCollection 2020. |
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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.
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Participants will be allocated into four parallel groups according to glucose tolerance status and intervention allocation: NGT-C, normal glucose tolerance control group receiving standard obstetric care and routine dietitian consultation; NGT-I, normal glucose tolerance intervention group receiving standard care plus structured nutrition counseling; GDM-C, gestational diabetes mellitus control group receiving standard gestational diabetes management and routine dietitian consultation; and GDM-I, gestational diabetes mellitus intervention group receiving standard gestational diabetes management plus structured nutrition counseling.
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The laboratory personnel performing biochemical analyses will be blinded to group allocation. Participants and the dietitian delivering the intervention will not be blinded due to the nature of the nutrition counseling intervention.
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| Standard Care | Other | Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation. |
|
| 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. | 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. | 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. | At delivery |
| Gestational Age at Birth | Gestational age at birth will be recorded in completed weeks after delivery from obstetric records. | At delivery |
| Congenital Anomaly Status | The presence or absence of congenital anomaly will be recorded after delivery from obstetric and neonatal records. | At delivery |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |