Gestational Diabetes Mellitus, Pregnancy
Conditions
Keywords
Advanced Glycation End Products, Diet Quality, Nutrition Counseling, Dietary Habits, Highly Processed Food Consumption
Brief summary
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.
Interventions
BEHAVIORALStructured 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.
OTHERStandard Care
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
Sponsors
Istanbul Saglik Bilimleri University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diet Quality Score | 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. |
| Serum Advanced Glycation End Products Level | 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
| Measure | Time frame | Description |
|---|---|---|
| Highly Processed Food Consumption Score | 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. |
| Dietary Habits and Cooking Methods | 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. |
| Gestational Weight Gain | 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. |
| Birth Weight | At delivery | Infant birth weight will be recorded in grams after delivery from obstetric and neonatal records. |
| Gestational Age at Birth | At delivery | Gestational age at birth will be recorded in completed weeks after delivery from obstetric records. |
| Congenital Anomaly Status | At delivery | The presence or absence of congenital anomaly will be recorded after delivery from obstetric and neonatal records. |
Contacts
CONTACTBEYZANUR ÇAMLIBEL, Dietitian / PhD Candidate
Outcome results
None listed