Nutrition Counseling, Diet Quality, and Advanced Glycation End Products in Gestational Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Structured Nutrition Counseling, Standard Care.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes Mellitus, Pregnancy. Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Relationship Between Nutrition Counseling in Gestational Diabetes Mellitus and Diet Quality and Advanced Glycation End Products
Overview
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
- Behavioral Structured 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 fac - Other Standard Care
Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.
Primary outcome measures
- Diet Quality Score [Time frame: Baseline at 24-28 weeks of gestation and final assessment at 32-36 weeks of gestation]
- Serum Advanced Glycation End Products Level [Time frame: Final assessment at approximately 32-36 weeks of gestation]
Secondary outcome measures (6)
- 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]
- 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]
- 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]
- Birth Weight [Time frame: At delivery]
- Gestational Age at Birth [Time frame: At delivery]
- Congenital Anomaly Status [Time frame: At delivery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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. PMID 33085688
Identifiers
NCT: NCT07636577 · 25-49