Mediterranean Diet Intervention for Maternal Postpartum (MedMom)

Universidade do Porto

Status: Enrolling

Conditions: Cardiac Reverse Remodeling; Cardiometabolic Factors; Postpartum

Treatments: Other: Control Group (Standard Hospital Dietary Care); Other: Mediterranean Diet Intervention Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07038681

MedMom

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups, including a placebo group

Control Group (Standard Hospital Dietary Care)

Placebo Comparator group

Description:

Since all the pregnant women in this study have at least one of the following risk factors: obesity, diabetes or hypertension, nutritional follow-up is a standard-care procedure in the Portuguese National Health System, therefore the control group receive usual care from the nutritionist in the hospital.

Treatment:

Other: Control Group (Standard Hospital Dietary Care)

Mediterranean Diet Intervention Group

Experimental group

Description:

In addition to the standard-care follow-up in the Portuguese National Health System, the intervention group will have additionally three approaches within the intervention: i) one face-to-face appointment lasting 10 to 15 minutes conducted by a registered dietitian (3rd trimester: 30 - 35 gestational weeks); ii) a 13-page manual that accompanies the dietary education session, which is provided to each participant; and iii) five monthly newsletters sent via e-mail from two weeks after childbirth until the fifth month postpartum.

Treatment:

Other: Mediterranean Diet Intervention Group