Mediterranean Diet program for postpartum heart and metabolic health
Mediterranean Diet Intervention for Maternal Postpartum Cardiometabolic and Microbiome Health (MedMom Study): a Randomized Trial
NA · Universidade do Porto · NCT07038681
This project tests whether teaching pregnant women with obesity, high blood pressure, or diabetes to follow a Mediterranean Diet helps improve their heart and metabolic health after birth.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universidade do Porto (other) |
| Locations | 1 site (Porto, Viana do Castelo District) |
| Trial ID | NCT07038681 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial randomizes pregnant women with obesity and/or chronic or gestational hypertension or diabetes to a Mediterranean Diet education program or to standard hospital dietary care. The intervention consists of one face-to-face education session supported by a 13-page manual and five monthly newsletters sent by email to reinforce adherence. Outcomes include diet adherence and cardiometabolic measures, with a primary focus on cardiac reverse remodeling, glycemic and blood pressure control, postpartum weight recovery, and changes in the fecal microbiota. Secondary aims include observing any effects on exclusive breastfeeding and the timing of introducing complementary foods to infants.
Who should consider this trial
Good fit: Pregnant women aged over 18 with obesity and/or chronic or gestational hypertension or diabetes who can attend an in-person session are the ideal candidates.
Not a fit: Patients with preexisting cardiomyopathy, significant renal or pulmonary disease, active systemic infection, genetic syndromes, or type 1 diabetes are excluded and unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could improve mothers' cardiac and metabolic health after delivery and support healthier weight recovery and gut microbiota patterns.
How similar studies have performed: Mediterranean diet programs have improved cardiometabolic outcomes in other adult populations, but applying this approach to postpartum cardiac reverse remodeling is relatively novel and being piloted here.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Porto, Viana do Castelo District
- Unidade Local de Saúde de São João — Porto, Viana do Castelo District, Portugal (RECRUITING)
Study contacts
- Principal investigator: Inês Falcão Pires, PhD — Universidade do Porto
- Study coordinator: Juliana Morais, Master
- Email: ju_morais17@hotmail.com
- Phone: 220426820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postpartum, Cardiometabolic Factors, Cardiac Reverse Remodeling, Mediterranean Diet, Pregnancy