Active — Not RecruitingNot Applicable

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

Italy216 participantsStarted 2023-02-13

Plain-language 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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: From enrollment (12-17 weeks of gestation) to delivery.

Trial details

NCT IDNCT07550309

SponsorAzienda Sanitaria Locale CN2 Alba-Bra

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04

View on ClinicalTrials.gov More Pregnancy trials