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

Longitudinal, Randomized, Parallel-Group, Controlled Clinical Study to Evaluate the Effectiveness of a Nutritional Education Intervention in Uncomplicated Pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07550309
Acronym
MaNu
Enrollment
216
Registered
2026-04-24
Start date
2023-02-13
Completion date
2026-05-01
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Nutritional education in pregnancy, Group-based dietary intervention, Gestational weight gain, Uncomplicated pregnancy, Randomized controlled trial, Prenatal nutrition counseling, Maternal diet intervention, Dietary behavior change in pregnancy, Oxidative stress in pregnancy, Pregnancy weight management, Telemedicine weight monitoring, Pregnancy

Brief 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

Detailed description

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.

Interventions

BEHAVIORALStructured 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.

OTHERRoutine 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

Azienda Sanitaria Locale CN2 Alba-Bra
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Participants are randomized in a 1:1 ratio to either a structured nutritional education intervention group or a control group receiving routine prenatal care with provision of a nutritional information brochure. The study uses a parallel-group design, with each participant assigned to a single study arm and followed longitudinally throughout pregnancy and up to 8 weeks postpartum. Randomization is stratified according to pre-pregnancy body mass index (BMI) categories and parity, using permuted blocks to ensure balance between groups.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Participants Achieving Gestational Weight Gain Within Institute of Medicine (IOM) Recommended RangesFrom 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.

Secondary

MeasureTime frameDescription
Change in Urinary Oxidative Stress Biomarkers During PregnancyFrom enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.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.
Change in Dietary Intake During PregnancyFrom enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.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.
Change in Maternal Quality of Life During PregnancyFrom enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.This outcome evaluates changes in maternal quality of life using the WHOQOL-BREF questionnaire and the number of self-reported healthy days.
Change in Maternal Body Composition During PregnancyFrom enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.This outcome measures changes in maternal body composition assessed by bioelectrical impedance analysis.
Gestational Weight Gain Rate Within Institute of Medicine RecommendationsFrom enrollment (12-17 weeks of gestation) to delivery.This outcome evaluates the weekly rate of gestational weight gain according to Institute of Medicine (IOM) recommendations based on pre-pregnancy BMI.
Incidence of Maternal Pregnancy ComplicationsFrom enrollment (12-17 weeks of gestation) to delivery.This outcome assesses the incidence of gestational diabetes mellitus, hypertensive disorders of pregnancy (including preeclampsia/eclampsia), and preterm birth.
Incidence of Neonatal ComplicationsAt delivery.This outcome evaluates neonatal outcomes including macrosomia and small-for-gestational-age infants.
Postpartum Maternal Weight ChangeFrom delivery to 8 weeks postpartum.This outcome assesses maternal weight change at 8 weeks postpartum compared with pre-pregnancy weight.

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORCloè Dalla Costa

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026