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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy; Oxidative Stress; Nutrition Therapy; Weight Gain During Pregnancy; Diet, Food and Nutrition; Uncomplicated Pregnancy
• Intervention / Treatment: Behavioral: Structured Nutritional Education Program; Other: Routine Prenatal Care With Nutritional Information Brochure

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.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • CN
    • Verduno, CN, Italy, 12060
      • SC Nutrizione Clinica e Disturbi del Comportamento Alimentare ASL CN2, Italy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Structured Nutritional Education Intervention; Participants receive a structured group-based nutritional education program delivered during pregnancy by trained healthcare professionals. The intervention includes group educational sessions focused on healthy dietary patterns during pregnancy, nutrient requirements, meal planning, and gestational weight management, plus one practical cooking (show-cooking) session. Participants are followed longitudinally through pregnancy and postpartum and complete the same study assessments as the control arm.	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.
Active Comparator: Routine Care + 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. This arm serves as the control condition for comparison with the structured nutritional education intervention. Participants are followed longitudinally through pregnancy and postpartum and complete the same study assessments as the intervention arm.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving Gestational Weight Gain Within Institute of Medicine (IOM) Recommended Ranges	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.	From enrollment (12-17 weeks of gestation) to delivery.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale CN2 Alba-Bra
• Investigators: Principal Investigator: Cloè Dalla Costa, SC Nutrizione Clinica e Disturbi del Comportamento Alimentare, Ospedale Michele e Pietro Ferrero, ASL CN2, Verduno (CN), Italy

Publications and helpful links

General Publications

• Simon-Szabo Z, Fogarasi E, Nemes-Nagy E, Denes L, Croitoru M, Szabo B. Oxidative stress and peripartum outcomes (Review). Exp Ther Med. 2021 Jul;22(1):771. doi: 10.3892/etm.2021.10203. Epub 2021 May 17.
• Santander Ballestin S, Gimenez Campos MI, Ballestin Ballestin J, Luesma Bartolome MJ. Is Supplementation with Micronutrients Still Necessary during Pregnancy? A Review. Nutrients. 2021 Sep 8;13(9):3134. doi: 10.3390/nu13093134.
• Marshall NE, Abrams B, Barbour LA, Catalano P, Christian P, Friedman JE, Hay WW Jr, Hernandez TL, Krebs NF, Oken E, Purnell JQ, Roberts JM, Soltani H, Wallace J, Thornburg KL. The importance of nutrition in pregnancy and lactation: lifelong consequences. Am J Obstet Gynecol. 2022 May;226(5):607-632. doi: 10.1016/j.ajog.2021.12.035. Epub 2021 Dec 27.
• Hussain T, Murtaza G, Metwally E, Kalhoro DH, Kalhoro MS, Rahu BA, Sahito RGA, Yin Y, Yang H, Chughtai MI, Tan B. The Role of Oxidative Stress and Antioxidant Balance in Pregnancy. Mediators Inflamm. 2021 Sep 27;2021:9962860. doi: 10.1155/2021/9962860. eCollection 2021.
• de Andrade Ramos BR, Witkin SS. The influence of oxidative stress and autophagy cross regulation on pregnancy outcome. Cell Stress Chaperones. 2016 Sep;21(5):755-62. doi: 10.1007/s12192-016-0715-3. Epub 2016 Jul 6.
• Aleksandrova K, Koelman L, Rodrigues CE. Dietary patterns and biomarkers of oxidative stress and inflammation: A systematic review of observational and intervention studies. Redox Biol. 2021 Jun;42:101869. doi: 10.1016/j.redox.2021.101869. Epub 2021 Jan 22.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Randomized controlled trial; Gestational weight gain; Nutritional education in pregnancy; Group-based dietary intervention; Uncomplicated pregnancy; Prenatal nutrition counseling; Maternal diet intervention; Dietary behavior change in pregnancy; Oxidative stress in pregnancy; Pregnancy weight management; Telemedicine weight monitoring
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gestational Weight Gain
• Other Study ID Numbers: MaNu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No