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NCT Number: NCT07038681

Mediterranean Diet Intervention for Maternal Postpartum

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.

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Key information

Conditions

Postpartum Cardiac Reverse Remodeling Cardiometabolic Factors

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Unidade Local de Saúde de São João

Porto, Viana do Castelo District, 4200-319, Portugal

Location status: Recruiting

Location contact

Juliana Morais, Master

CONTACT

[email protected]

225512100 + 962711106 ext. +351

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean Diet Intervention Group

Other

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 names: Diet group

Control Group (Standard Hospital Dietary Care)

Other

The control group will receive standard care from the nutritionist in the hospital.

Primary outcomes

  1. 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)

    To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the. Portuguese National Health System (Control Group: Standard Hospital Dietary Care)) on the percentage change of the Mediterranean Diet Adherence Screener (MEDAS) score.

    The MEDAS score ranges from 0 to 14, with higher scores indicating greater adherence to the Mediterranean Diet. Scores are commonly classified as follows:

    • Low adherence: < 7
    • Moderate adherence: 7-9
    • High adherence: ≥ 10

Secondary outcomes

  1. 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).

    To assess the effect of dietary education counseling focused on Mediterranean Diet promotion (intervention group) vs control group on cardiac reverse remodeling, evaluated through echocardiographic measurements of cardiac structure and function during pregnancy and postpartum.

    Cardiac reverse remodeling will be assessed as the change (Δ) in left ventricular (LV) mass between the third trimester of pregnancy and 6 months postpartum.

    Conventional transthoracic echocardiography will be performed using a 3 MHz phased-array probe (ACUSON SC2000 PRIME) by a single operator. Measurements will be obtained from standard parasternal and apical views, according to the European Society of Cardiology recommendations.

    Left ventricular mass (g) will be estimated using the following formula:

    LV mass = 0.8 × {1.04 × [(LVEDD + PWTd + IVSd)³ - (LVEDD)³]} + 0.6 where: LVEDD = LV end-diastolic diameter PWTdP = posterior wall thickness in diastole IVSd = interventricular septal thickness in diastole

  2. 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).

    To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the Portuguese National Health System (control group) on the percentage change of the following measures relative to the baseline measures.

  3. 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).

    To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the Portuguese National Health System (control group) on the percentage of the following measures relative to the baseline measures.

  4. 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).

    To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the Portuguese National Health System (control group) on the percentage of the following measures relative to the baseline measures.

  5. Recovery of gestational weight gain

    Time frame: Visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).

    To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the Portuguese National Health System (control group) on recovery of the gestational weight gain.

  6. 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).

    To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the Portuguese National Health System (control group) on the percentage change of the following measures relative to the baseline measures.

  7. 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).

    To assess the effect of the dietary education counseling focused Mediterranean Diet promotion (intervention group) vs nutritional standard-care of the Portuguese National Health System (control group) on the percentage change of the following measures relative to the baseline measures.

Other outcomes

  1. Age of Infant at Introduction of Complementary Feeding

    Time frame: Visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).

    To assess the effect of dietary education counseling focused on Mediterranean Diet promotion (intervention group) vs nutritional standard care of the Portuguese National Health System (control group) on the timing of complementary feeding (solid food) introduction in infants.

    At every time points, mothers will be asked using structured parental questionnaires to report the infant's age (in weeks) at the introduction of any solid or semi-solid foods, excluding breast milk or infant formula.

    The primary metric will be the infant's age in weeks at first introduction of complementary feeding.

  2. Duration of Exclusive Breastfeeding

    Time frame: Visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).

    To assess the effect of dietary education counseling focused on Mediterranean Diet promotion (intervention group) vs nutritional standard care of the Portuguese National Health System (control group) on the duration of exclusive breastfeeding.

    Exclusive breastfeeding is defined according to WHO criteria as providing only breast milk with no additional food or drink, not even water, except for oral rehydration solutions or drops/syrups of vitamins, minerals, or medicines.

    Data will be collected via structured parental. Mothers will report whether they are exclusively breastfeeding and the age (in weeks) at which exclusive breastfeeding stopped, if applicable.

    The outcome will be reported as the duration of exclusive breastfeeding in weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Filipa Ferreira, PhD

CONTACT

[email protected]

220426820 ext. +351

Juliana Morais, Master

CONTACT

[email protected]

220426820 ext. +351

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study title

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

Acronym: MedMom

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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