Mediterranean Diet Intervention for Maternal Postpartum Cardiometabolic and Microbiome Health (MedMom Study): a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Maternal Mediterranean Diet Adherence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female (>18 years old)
- •Chronic arterial hypertension
- •Type 2 diabetes
- •Gestational hypertension
- •Gestational diabetes
排除标准
- •Preexisting cardiomyopathy;
- •Renal disease;
- •Chronic obstructive airway disease;
- •Active systemic infection;
- •Genetic syndromes;
- •Type 1 Diabetes mellitus
研究组 & 干预措施
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.
干预措施: Control Group (Standard Hospital Dietary Care) (Other)
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.
干预措施: Mediterranean Diet Intervention Group (Other)
结局指标
主要结局
Maternal Mediterranean Diet Adherence
时间窗: 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
次要结局
- 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).)
- 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).)
- 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).)
- 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).)
- Recovery of gestational weight gain(Visit 2 (1 month postpartum), visit 3 (6 months postpartum) and visit 4 (12 months postpartum).)
- 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).)
- 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).)