Mediterranean Diet Intervention for Maternal Postpartum
NCT ID: NCT07038681
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
52 participants
INTERVENTIONAL
2025-05-31
2025-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
Control Group (Standard Hospital Dietary Care)
The control group will receive standard care from the nutritionist in the hospital.
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.
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.
Interventions
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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.
Control Group (Standard Hospital Dietary Care)
The control group will receive standard care from the nutritionist in the hospital.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Obesity
* Chronic arterial hypertension
* Type 2 diabetes
* Gestational hypertension
* Gestational diabetes
Exclusion Criteria
* Renal disease;
* Chronic obstructive airway disease;
* Active systemic infection;
* Genetic syndromes;
* Type 1 Diabetes mellitus
18 Years
FEMALE
No
Sponsors
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Universidade do Porto
OTHER
Responsible Party
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Principal Investigators
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Inês Falcão Pires, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade do Porto
Locations
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Unidade Local de Saúde de São João
Porto, Viana do Castelo District, Portugal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MedMom
Identifier Type: -
Identifier Source: org_study_id
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