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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult female (\>18 years old)

• Obesity

• Chronic arterial hypertension

• Type 2 diabetes

• Gestational hypertension

• Gestational diabetes

Locations
Other Locations
Portugal
Unidade Local de Saúde de São João
RECRUITING
Porto
Contact Information
Primary
Juliana Morais, Master
ju_morais17@hotmail.com
220426820
Backup
Ana Filipa Ferreira, PhD
anaferreira.ferreira4@gmail.com
220426820
Time Frame
Start Date: 2025-05-31
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 52
Treatments
Placebo_comparator: Control Group (Standard Hospital Dietary Care)
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.
Experimental: Mediterranean Diet Intervention Group
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.
Sponsors
Leads: Universidade do Porto

This content was sourced from clinicaltrials.gov

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