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

Key facts

Who runs it
Hospital San Carlos, Madrid
Where
Spain1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
1,200 people, planned
Started
15 Sept 2026
Expected to end
31 Dec 2028
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Nutritional intervention based on a Mediterranean diet
Record updated
16 September 2026

Who can take part

Age
18 years to 50 years
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • Unassisted single pregnancy
  • Age between 18 and 50 years old
  • Fasting blood glucose <92 mg/dl in the first gestational blood test
  • First trimester ultrasound before the 12th gestational week

Who cannot take part

  • Any pregestational illness or pregestational treatment that may affect pregnancy
  • Known intolerance/allergy to any component of the nutritional intervention
  • Multiple or assisted pregnancies

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 50 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Standard treatmentNo study treatment, for comparison

    The nutritional intervention will consist of providing information on healthy lifestyle measures through an 8-minute informational video (accessible via QR code at the consultation room or the permanent link https://www.youtube.com/watch?v=Qgcz5t9B9WI). Routine obstetric follow-up does not involve subsequent monitoring of adherence to these recommendations, beyond the usual follow-up.

  • Advanced treatmentTreatment being tested

    A specific nutritional intervention consisting of a group session that will last approximately one hour, led by a nutritionist from the research team. This session will explain in detail 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. Two telephonic interviews will be scheduled for follow-up around gestational weeks 16 and 20 to provide motivation and assess and reinforce adherence to these recommendations.

    Treatment: Nutritional intervention based on a Mediterranean diet

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect of an Early and Intensified Nutritional Intervention Based on a Mediterranean Diet (MedDiet) in Women With Clinical-genetic Risk of Developing Gestational Diabetes Mellitus (GDM): a Randomized, Parallel, Interventional, Controlled Clinical Trial
Fit questions
Built from NCT07817017, who can take part
Record updated
16 September 2026