An interventional study of Structured Nutritional Education Program and Routine Prenatal Care With Nutritional Information Brochure in Pregnancy, Uncomplicated Pregnancy and Diet, Food and Nutrition, sponsored by Azienda Sanitaria Locale CN2 Alba-Bra. Active, not recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Azienda Sanitaria Locale CN2 Alba-Bra · Not applicable, Interventional, and Prevention
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:
Participants in the control group will:
All participants (including control group) will:
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.
The longitudinal structure of the study allows evaluation of both short-term behavioral changes during pregnancy and medium-term maternal outcomes extending into the postpartum period. The integration of behavioral, anthropometric, and biochemical assessments enables a multidimensional evaluation of the intervention's impact.
119 studies on the registry are indexed under Gestational Weight Gain; 20 are open to participants now.
This study's enrollment of 216 is above the median of 108 across 100 interventional studies indexed under Gestational Weight Gain.
Browse Gestational Weight Gain studies →Azienda Sanitaria Locale CN2 Alba-Bra is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Structured Nutritional Education Program
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.
Other: Routine Prenatal Care With Nutritional Information Brochure
Participants receive a structured group-based nutritional education program delivered during pregnancy by trained healthcare professionals. The program includes three weekly group educational sessions and one practical cooking (show-cooking) session. The intervention focuses on improving knowledge and practical skills related to healthy dietary patterns during pregnancy, nutrient intake, and gestational weight management.
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. No structured educational sessions or group-based interventions are delivered in this arm.
Proportion of Participants Achieving Gestational Weight Gain Within Institute of Medicine (IOM) Recommended Ranges
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.
Time frame: From enrollment (12-17 weeks of gestation) to delivery.
Change in Urinary Oxidative Stress Biomarkers During Pregnancy
This outcome evaluates changes in oxidative stress status during pregnancy by measuring urinary levels of isoprostanes and malondialdehyde, as well as total antioxidant capacity, using validated laboratory assays.
Time frame: From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.
Change in Dietary Intake During Pregnancy
This outcome assesses changes in dietary intake, including energy intake and macronutrient distribution (carbohydrates, proteins, fats including saturated and unsaturated fatty acids, and dietary fiber), measured using a validated food frequency questionnaire.
Time frame: From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.
Change in Maternal Quality of Life During Pregnancy
This outcome evaluates changes in maternal quality of life using the WHOQOL-BREF questionnaire and the number of self-reported healthy days.
Time frame: From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.
Change in Maternal Body Composition During Pregnancy
This outcome measures changes in maternal body composition assessed by bioelectrical impedance analysis.
Time frame: From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.
Gestational Weight Gain Rate Within Institute of Medicine Recommendations
This outcome evaluates the weekly rate of gestational weight gain according to Institute of Medicine (IOM) recommendations based on pre-pregnancy BMI.
Time frame: From enrollment (12-17 weeks of gestation) to delivery.
Incidence of Maternal Pregnancy Complications
This outcome assesses the incidence of gestational diabetes mellitus, hypertensive disorders of pregnancy (including preeclampsia/eclampsia), and preterm birth.
Time frame: From enrollment (12-17 weeks of gestation) to delivery.
Incidence of Neonatal Complications
This outcome evaluates neonatal outcomes including macrosomia and small-for-gestational-age infants.
Time frame: At delivery.
Postpartum Maternal Weight Change
This outcome assesses maternal weight change at 8 weeks postpartum compared with pre-pregnancy weight.
Time frame: From delivery to 8 weeks postpartum.
Plan to share: Undecided
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Azienda Sanitaria Locale CN2 Alba-Bra