Effect of an Early and Intensified Nutritional Intervention on the Risk of Developing Gestational Diabetes Mellitus

Condition(s) studied

Investigational drug(s) / intervention(s)

Nutritional intervention based on a Mediterranean diet: The nutritional intervention consists of a 1-hour group session led by a nutritionist from the research team. Includes a detailed description of the key aspects of the MedDiet: consumption of \>40 ml/day of extra virgin olive oil, 30 g of nuts per day, 3-4 pieces of whole fruit (not juice), homemade stir-fries, 2-3 servings of vegetables and/or salads per day, 2-3 servings per day of low-fat dairy products, whole grains, 2-3 servings of legumes per week, consumption of fish, limiting the consumption of red meat, and avoiding ultra-processed products, sliced bread, soft drinks, juices, fast food, and pre-cooked products. In addition, 2 telephonic interviews for follow-up (gestational weeks 16 and 20) to reinforce adherence and emphasize consumption of \>40 ml/day of extra virgin olive oil, 30 g of nuts per day, 3-4 pieces of whole fruit (not juice), daily vegetables and daily physical activity.

Study summary

The goal of this clinical trial is to learn if a nutritional intervention based on a Mediterranean diet (MedDiet), initiated early in pregnancy, reduces the incidence of gestational diabetes mellitus (GDM) and other adverse maternal, fetal and obstetric events in pregnant women considered high-risk. It will also learn about the stratification of GDM risk based on clinical, anthropometric, analytical and genetic characteristics.

The main questions it aims to answer are:

* Does the nutritional intervention based on MedDiet reduce the incidence of GDM in women with high risk?
* How can we stratify the risk of GDM? Researchers will compare an advanced nutritional intervention based on a Mediterranean diet to standard care (general recommendations given at the beginning of pregnancy).

Participants will:

* Receive intensive nutritional counselling or standard regular recommendations during the first trimester of pregnancy.
* Visit the clinic at the time of the first ultrasound (gestational week 8-11) and at the time of screening for GDM (gestational week 24-26).
* Undergo a genetic test performed with a buccal swab.

Eligibility

Primary outcome measure(s)

• Incidence of gestational diabetes mellitus — From enrollment (gestational week 8-11) to the time of screening for gestational diabetes mellitus (gestational week 24-26)
  The general objective of this study is to determine whether an advanced nutritional intervention based on Mediterranean diet reduces the incidence of gestational diabetes mellitus and other adverse maternal-fetal obstetric and endocrine-metabolic events in pregnant women considered high-risk based on a risk score derived from the interaction between associated genetic polymorphisms, baseline clinical characteristics, and anthropometric characteristics of pregnant women. The primary outcome is the comparison of the frequency of GDM, according to IADPSG criteria, between the MedDiet intervention group and the standard treatment group in women at high risk according to the calculated risk of developing GDM.

Trial sites (1)

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