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Clinical Trials in Portugal / NCT07038681
Recruiting Not applicable

Mediterranean Diet Intervention for Maternal Postpartum

NCT07038681 · tracked via the Priya Life Science Portugal tracker
Phase
Not applicable
Started
2025-05-31
Last updated
2025-06-26

Condition(s) studied

PostpartumCardiometabolic FactorsCardiac Reverse Remodeling

Investigational drug(s) / intervention(s)

Mediterranean Diet Intervention GroupControl Group (Standard Hospital Dietary Care)

Mediterranean Diet Intervention Group: In the same way as the control group, the intervention group receives standard nutritional care from the hospital nutritionist, since all the pregnant women have at least one of the following risk factors: obesity, diabetes or hypertension, nutritional - standard-care procedure in the Portuguese National Health System.

Control Group (Standard Hospital Dietary Care): The control group will receive standard care from the nutritionist in the hospital.

Study summary

The increasing prevalence of obesity during women's reproductive years highlights the need for effective strategies to improve nutritional literacy as a preventive approach to adverse postnatal outcomes.

This study outlines a protocol for a pilot randomized controlled trial assessing the potential of nutritional education sessions promoting the Mediterranean Diet (MedDiet) to improve adherence to this diet and evaluate its effects on cardiometabolic outcomes, namely on cardiac reverse remodeling, glycemic and blood pressure control, as well as on preconception weight recovery and changes in the fecal microbiota composition in pregnant women with obesity, hypertension, and/or diabetes.

Secondarily, this study aims to evaluate how this dietary intervention indirectly interferes with infants' exclusive breastfeeding and the introduction of complementary feeding. It includes a face-to-face session using an eye-catching 13-page manual, followed by five monthly newsletters sent by e-mail. Participants will be monitored at one, six, and twelve months postpartum to evaluate the intervention's effectiveness. Findings from this study will contribute to the development of an evidence-based nutritional education tool designed to improve maternal health outcomes, with potential applicability for both health professionals and pregnant and postpartum women.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult female (\>18 years old) * Obesity * Chronic arterial hypertension * Type 2 diabetes * Gestational hypertension * Gestational diabetes Exclusion Criteria: * Preexisting cardiomyopathy; * Renal disease; * Chronic obstructive airway disease; * Active systemic infection; * Genetic syndromes; * Type 1 Diabetes mellitus

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Unidade Local de Saúde de São João Porto Viana do Castelo District Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07038681 on ClinicalTrials.gov ↗ ← All trials in Portugal