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GDM and maternal-fetal adverse outcomes rates after providing lifestyle recommendations based on a motivational video early in pregnancy. The St Carlos video_MED_DIET Study

The St Carlos video_MED_DIET Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN20122349
Enrollment
525
Registered
2023-11-02
Start date
2023-12-01
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes mellitus Nutritional, Metabolic, Endocrine

Interventions

A nutritional intervention based on the Mediterranean diet will be given to all pregnant women attending the study hospital in the first gestational visit (gestational weeks 8 to 12). Due to the sign

Sponsors

Biomedical Research Institute (IdISSC) Foundation for Biomedical Research, Hospital Clinico San Carlos
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women at least 18 years old 2. Normal fasting blood glucose values in the first gestational assessment

Exclusion criteria

Exclusion criteria: 1. Women with fasting blood glucose >92 mg/dl in the first gestational assessment 2. Nuts or olive oil intolerance 3. Multiple pregnancy and any medical condition, treatment or diet intervention that the medical team considers to influence the effects of the study intervention. 4. Women with specific nutritional treatments

Design outcomes

Primary

MeasureTime frame
Incidence of Gestational Diabetes Mellitus in each group diagnosed with a 75 g oral glucose load by IADPSG criteria at 24-28 gestational weeks

Secondary

MeasureTime frame
1. Incidence of pre-eclampsia during pregnancy, as assessed using a blood pressure measurement and albuminuria in urine sample 2. Number of instrumental delivery and caesarean sections at birth, as assessed using obstetric medical records 3. Number of small for gestational age new-borns, macrosomic new-borns, and assessed using birth weight 4. Number of admissions to the paediatric intensive care unit at birth 5 Number of New-Borns before 37 gestational weeks 6. Weight gain is assessed weight at the 8-12 weeks gestational visit and the 38 gestational week visit and also by declared pregestational weight and that obtained at the 38 gestational week

Countries

Spain

Contacts

Public ContactAlfonso Luis Calle Pascual
alfonsca@ucm.es+34 91 3303281

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026