NCT07038681 Mediterranean Diet Intervention for Maternal Postpartum
| NCT ID | NCT07038681 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidade do Porto |
| Condition | Postpartum |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-05-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2025-05-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Inês Falcão Pires, PhD
PRINCIPAL INVESTIGATOR
Universidade do Porto
Frequently Asked Questions
Who can join the NCT07038681 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postpartum. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07038681 currently recruiting?
Yes, NCT07038681 is actively recruiting participants. Contact the research team at ju_morais17@hotmail.com for enrollment information.
Where is the NCT07038681 trial being conducted?
This trial is being conducted at Porto, Portugal.
Who is sponsoring the NCT07038681 clinical trial?
NCT07038681 is sponsored by Universidade do Porto. The principal investigator is Inês Falcão Pires, PhD at Universidade do Porto. The trial plans to enroll 52 participants.