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Recruiting NCT07038681

Mediterranean Diet Intervention for Maternal Postpartum

No phase Interventional Postpartum Cardiometabolic Factors Cardiac Reverse Remodeling

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mediterranean Diet Intervention Group, Control Group (Standard Hospital Dietary Care).
Who it may be relevant to
Registry conditions: Postpartum, Cardiometabolic Factors, Cardiac Reverse Remodeling. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Mediterranean Diet Intervention for Maternal Postpartum Cardiometabolic and Microbiome Health (MedMom Study): a Randomized Trial

Overview

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.

Interventions

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

Primary outcome measures

  • Maternal Mediterranean Diet Adherence [Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum)]
Secondary outcome measures (7)
  • Left Ventricular Reverse Remodeling Assessed by Echocardiography (Cardiac reserve remodeling) [Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).]
  • Gut Microbiota [Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).]
  • Systolic blood pressure [Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).]
  • Diastolic blood pressure [Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).]
  • Recovery of gestational weight gain [Time frame: Visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).]
  • Glucose [Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).]
  • Haemoglobin A1c [Time frame: Visit 1 (3rd trimester - 30-25 gestational weeks), visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Portugal · 1 center
  • Unidade Local de Saúde de São João — Porto

Identifiers

NCT: NCT07038681 · MedMom

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗