Longitudinal Randomized Controlled Study on the Effectiveness of Nutritional Education During Uncomplicated Pregnancy

NCT07550309 · tracked via the Priya Life Science Italy tracker

Sponsor

Azienda Sanitaria Locale CN2 Alba-Bra

Phase

Not applicable

Started

2023-02-13

Last updated

2026-04-24

Condition(s) studied

PregnancyUncomplicated PregnancyDiet, Food and NutritionWeight Gain During PregnancyOxidative StressNutrition Therapy

Investigational drug(s) / intervention(s)

Structured Nutritional Education ProgramRoutine Prenatal Care With Nutritional Information Brochure

Structured Nutritional Education Program: 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.

Routine Prenatal Care With Nutritional Information 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. No structured educational sessions or group-based interventions are delivered in this arm.

Study summary

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

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Proportion of Participants Achieving Gestational Weight Gain Within Institute of Medicine (IOM) Recommended Ranges — 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.

Trial sites (1)

Facility	City	Region	Status
SC Nutrizione Clinica e Disturbi del Comportamento Alimentare ASL CN2, Italy	Verduno	CN

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07550309 on ClinicalTrials.gov ↗ ← All trials in Italy