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

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

Conditions

• Pregnancy
• Uncomplicated Pregnancy
• Diet, Food and Nutrition
• Weight Gain During Pregnancy
• Oxidative Stress
• Nutrition Therapy

Interventions

BEHAVIORAL

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.

OTHER

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.

Sponsors & Collaborators

• Azienda Sanitaria Locale CN2 Alba-Bra

  lead OTHER

Principal Investigators

• Cloè Dalla Costa · SC Nutrizione Clinica e Disturbi del Comportamento Alimentare, Ospedale Michele e Pietro Ferrero, ASL CN2, Verduno (CN), Italy

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-13

Primary Completion

2026-04-30

Completion

2026-05-31

Countries

• Italy

Study Locations