Cardiac Reverse Remodeling, Cardiometabolic Factors, Postpartum
Conditions
Keywords
Mediterranean Diet, Postpartum, Pregnancy, Cardiac Reverse Remodeling
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.
Interventions
OTHERMediterranean 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.
OTHERControl Group (Standard Hospital Dietary Care)
The control group will receive standard care from the nutritionist in the hospital.
Sponsors
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Prospective, randomized, two-treatment, one-period, parallel trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Age of Infant at Introduction of Complementary Feeding | 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 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. |
| Duration of Exclusive Breastfeeding | 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 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. |
Countries
Portugal
Contacts
Primary ContactJuliana Morais, Master
Backup ContactAna Filipa Ferreira, PhD
Outcome results
None listed