Longitudinal, Randomized, Parallel-Group, Controlled Clinical Study to Evaluate the Effectiveness of a Nutritional Education Intervention in Uncomplicated Pregnancy
Sponsor: Azienda Sanitaria Locale CN2 Alba-Bra
Trial Details
| Condition | Pregnancy, Uncomplicated Pregnancy, Diet, Food and Nutrition, Weight Gain During Pregnancy, Oxidative Stress, Nutrition Therapy |
| Intervention | Structured Nutritional Education Program; Routine Prenatal Care With Nutritional Information Brochure |
| Phase | NA |
| Status | Active |
| Participants | 216 |
| Est. Completion | 1 Apr 2026 |
| Last Updated | 24 Apr 2026 |
Primary Outcome
Proportion of Participants Achieving Gestational Weight Gain Within Institute of Medicine (IOM) Recommended Ranges
Eligibility Criteria
Inclusion Criteria
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
Trial Sites
Countries
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