Longitudinal, Randomized, Parallel-Group, Controlled Clinical Study to Evaluate the Effectiveness of a Nutritional Education Intervention in Uncomplicated Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Proportion of Participants Achieving Gestational Weight Gain Within Institute of Medicine (IOM) Recommended Ranges
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a structured nutritional education intervention can improve gestational weight gain outcomes and related maternal and neonatal health indicators in women with uncomplicated pregnancy. The main question it aims to answer is whether a group-based nutritional education program increases the proportion of women achieving gestational weight gain within Institute of Medicine (IOM) recommended ranges compared with standard prenatal care.
Researchers will compare a structured nutritional education intervention group to a control group receiving routine prenatal care and a nutritional information brochure to see if the intervention improves gestational weight gain within recommended ranges and affects maternal and neonatal outcomes.
Participants in the intervention group will:
- Attend three weekly group-based nutritional education sessions delivered by trained healthcare professionals
- Attend one practical cooking (show-cooking) session
Participants in the control group will:
- Receive routine prenatal care and a written nutritional information brochure
- Be followed from early pregnancy until 8 weeks postpartum
All participants (including control group) will:
- Record body weight regularly throughout pregnancy using a telemedicine system
- Complete questionnaires on dietary intake and quality of life at multiple time points
- Undergo assessments of body composition and urinary biomarkers of oxidative stress during pregnancy
详细描述
This study is based on the hypothesis that dietary behavior during pregnancy plays a key role in determining maternal metabolic adaptation and pregnancy outcomes, particularly through its influence on gestational weight gain regulation and oxidative stress balance.
Pregnancy is characterized by physiological metabolic and endocrine adaptations that increase susceptibility to both under- and over-nutrition. Inadequate dietary patterns may contribute to excessive gestational weight gain, which has been associated with increased risk of maternal and neonatal complications. Conversely, nutritional imbalance may also affect fetal development and long-term health trajectories. Despite existing recommendations for healthy eating during pregnancy, adherence in real-world settings remains suboptimal, suggesting the need for structured behavioral interventions.
In addition to metabolic effects, pregnancy is associated with a physiological increase in oxidative stress, which is involved in placental development and fetal growth regulation. However, excessive oxidative stress has been linked to adverse outcomes including impaired placental function and increased risk of metabolic and hypertensive disorders. Dietary patterns rich in antioxidants, such as those emphasizing high-quality nutrients and balanced macronutrient intake, may contribute to modulating oxidative stress pathways.
The intervention tested in this study is grounded in behavioral nutrition and health education principles, with the aim of improving dietary awareness, food selection skills, and long-term adherence to nutritional recommendations. The group-based format is designed to enhance engagement, facilitate peer interaction, and improve cost-effectiveness compared to individual counseling approaches.
The study employs a randomized controlled design to minimize selection bias and allow causal inference regarding the effect of the intervention. Stratified randomization is used to ensure balance across clinically relevant prognostic factors, including pre-pregnancy BMI and parity, which are known to influence gestational weight gain and pregnancy outcomes.
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
- None
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
- •Pregnant women with gestational age ≤ 17 weeks at enrollment
- •Age ≥ 18 years
- •Ability to provide written informed consent
- •Availability of a personal smartphone for study participation and data reporting
- •Availability of a personal weight scale for home monitoring
排除标准
- •Multiple pregnancy
- •Pre-existing hypertension
- •Pre-existing diabetes mellitus
- •Pre-pregnancy body mass index (BMI) < 18.5 kg/m²
- •Pre-pregnancy body mass index (BMI) ≥ 35 kg/m²
- •History of psychiatric disorders
- •Overt hypothyroidism or hyperthyroidism
- •Celiac disease
- •Inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- •History of bariatric surgery
- •Language barrier preventing comprehension of study procedures or completion of assessments
研究组 & 干预措施
Structured Nutritional Education Intervention
Participants receive a structured group-based nutritional education program delivered during pregnancy by trained healthcare professionals. The intervention includes group educational sessions focused on healthy dietary patterns during pregnancy, nutrient requirements, meal planning, and gestational weight management, plus one practical cooking (show-cooking) session. Participants are followed longitudinally through pregnancy and postpartum and complete the same study assessments as the control arm.
干预措施: Structured Nutritional Education Program (Behavioral)
Routine Care + Brochure
Participants receive routine prenatal care according to standard clinical practice. In addition, they are provided with a written nutritional information brochure containing general dietary recommendations for pregnancy. This arm serves as the control condition for comparison with the structured nutritional education intervention. Participants are followed longitudinally through pregnancy and postpartum and complete the same study assessments as the intervention arm.
干预措施: Routine Prenatal Care With Nutritional Information Brochure (Other)
结局指标
主要结局
Proportion of Participants Achieving Gestational Weight Gain Within Institute of Medicine (IOM) Recommended Ranges
时间窗: From enrollment (12-17 weeks of gestation) to delivery.
This outcome assesses the proportion of participants whose total gestational weight gain falls within the Institute of Medicine (IOM) recommended ranges according to pre-pregnancy body mass index (BMI) categories. Pre-pregnancy BMI is used to classify recommended weight gain ranges, and total gestational weight gain is evaluated at the end of pregnancy.
次要结局
- Change in Urinary Oxidative Stress Biomarkers During Pregnancy(From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.)
- Change in Dietary Intake During Pregnancy(From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.)
- Change in Maternal Quality of Life During Pregnancy(From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.)
- Change in Maternal Body Composition During Pregnancy(From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.)
- Gestational Weight Gain Rate Within Institute of Medicine Recommendations(From enrollment (12-17 weeks of gestation) to delivery.)
- Incidence of Maternal Pregnancy Complications(From enrollment (12-17 weeks of gestation) to delivery.)
- Incidence of Neonatal Complications(At delivery.)
- Postpartum Maternal Weight Change(From delivery to 8 weeks postpartum.)