Mediterranean Diet Intervention for Maternal Postpartum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversidade do Porto
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adult female (>18 years old)
Obesity
Chronic arterial hypertension
Type 2 diabetes
Disqualifiers
Preexisting cardiomyopathy;
Renal disease;
Chronic obstructive airway disease;
Active systemic infection;
Trial design
Design model
Parallel
Treatments tested in this trial
Mediterranean Diet Intervention Group
Other interventionIn 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)
Other interventionThe control group will receive standard care from the nutritionist in the hospital.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Control Group (Standard Hospital Dietary Care)Placebo comparator 1 intervention
Group B: Mediterranean Diet Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maternal Mediterranean Diet Adherence
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
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)Secondary outcomes
1
Left Ventricular Reverse Remodeling Assessed by Echocardiography (Cardiac reserve remodeling)
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
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).2
Gut Microbiota
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.
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).3
Systolic blood pressure
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.
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).4
Diastolic blood pressure
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.
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).Other outcomes
1
Age of Infant at Introduction of Complementary Feeding
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.
Time frame
Visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).2
Duration of Exclusive Breastfeeding
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.
Time frame
Visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).Sponsors and contacts
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Source ClinicalTrials.gov