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

NCT07550309 | Active Not Recruiting

• 1 other identifier: MaNu
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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

Conditions

Diet, Food and Nutrition; Oxidative Stress; Nutrition Therapy; 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in Urinary Oxidative Stress Biomarkers During Pregnancy

  From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.

• Change in Dietary Intake During Pregnancy

  From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.

• Change in Maternal Quality of Life During Pregnancy

  From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.

• Change in Maternal Body Composition During Pregnancy

  From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.

• Gestational Weight Gain Rate Within Institute of Medicine Recommendations

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

Study Arms (2)

Structured Nutritional Education Intervention

EXPERIMENTAL

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

Routine Care + Brochure

ACTIVE COMPARATOR

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

Interventions

Structured Nutritional Education Program BEHAVIORAL

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.

Structured Nutritional Education Intervention

Routine Prenatal Care With Nutritional Information Brochure OTHER

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.

Routine Care + Brochure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria Locale CN2 Alba-Bra: lead

Study Sites (1)

SC Nutrizione Clinica e Disturbi del Comportamento Alimentare ASL CN2, Italy

Verduno, CN, 12060, Italy

Location

Related Publications (6)

• 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.

  PMID: 34055070 RESULT

• 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.

  PMID: 34579011 RESULT

• 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.

  PMID: 34968458 RESULT

• 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.

  PMID: 34616234 RESULT

• 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.

  PMID: 27383757 RESULT

• 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.

  PMID: 33541846 RESULT

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cloè Dalla Costa

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 24, 2026
• Study Start: February 13, 2023
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

IT (1)