Mediterranean Diet Intervention for Maternal Postpartum

Not Applicable

Recruiting

• Conditions: Postpartum; Cardiometabolic Factors; Cardiac Reverse Remodeling

• Registration Number: NCT07038681
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-31
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal Mediterranean Diet Adherence	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 Outcome Measures

Name	Time	Method
Left Ventricular Reverse Remodeling Assessed by Echocardiography (Cardiac reserve remodeling)	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
Gut Microbiota	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.
Systolic blood pressure	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.
Recovery of gestational weight gain	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.
Glucose	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.
Haemoglobin A1c	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.
Diastolic blood pressure	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.

Trial Locations

Locations (1)

Unidade Local de Saúde de São João; 🇵🇹 Porto, Viana do Castelo, Portugal