Women and Maternity: Development of a Nutritional Education Project

NCT06264349 | Not Yet Recruiting

• 1 other identifier: 05102023
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The "first 1000 days of life", from conception to 2 years of life, are crucial for promoting the health of both mother and baby. During this period, a woman's diet and lifestyle play a significant role in determining the future health of the child. The perinatal period is an ideal time for regular contact with healthcare providers who can institute an intervention to encourage pregnant women to make nutritional changes to improve their health and that of their babies. Therefore, an educational program on an appropriate lifestyle during the "first 1000 days" can represent a crucial primary prevention strategy in reducing the risk of developing obesity and non-communicable diseases (NCDs) during childhood and later adulthood.

Conditions

Pregnancy; Lactation

Keywords

Lifestyle; Health; First one-thousand days; Dietary habits

Outcome Measures

Primary Outcomes (1)

• Gestational weight gain management

  Evaluation of the LEI program effectiveness on gestational weight gain (GWG) management. GWG (Kg) will be calculated retrospectively as the difference between the weight at the first and last prenatal visit, just before delivery. Based on that, women will be classified into 3 categories, according to the IOM (U.S.) and the National Research Council (U.S.) Committee to Reexamine IOM Pregnancy Weight Guidelines, as follow: i.) Women with Adequate GWG (AGWG; women with normal pre-pregnancy BMI, gaining from 11.5 Kg to 16 Kg during pregnancy); ii.) Women with Excessive GWG (EGWG; women with pre-pregnancy BMI indicating overweight or obesity, gaining more than 11.5 Kg or 9 Kg during pregnancy, respectively); and iii.)Women with Low GWG (LGWG; women with low pre-pregnancy weight status, gaining less than 12.5 Kg).

  GWG will be evaluated at T2 (1 month after delivery)

Secondary Outcomes (4)

• Nutritional aspects evaluation during pregnancy and lactation

  Nutritional aspects will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).

• Physical activity evaluation during pregnancy and lactation

  Physical activity will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).

• Smoking habits during pregnancy and lactation

  Smoking habits will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T1, three weeks before the delivery; T2, 4 weeks after the delivery; T3, 24 weeks after the delivery).

• Maternal attitude towards infant feeding.

  Maternal attitude towards infant feeding will be evaluated at the baseline (T0, first trimester) and after the LEI intervention (T2, 4 weeks after the delivery).

Study Arms (3)

Group A: frontal lessons

EXPERIMENTAL

50 women will receive a Lifestyle Educational Intervention (LEI) from research staff regarding a correct lifestyle during pregnancy and lactation through 6 interactive online lectures lasting approximately 30 minutes each.

Other: Lifestyle Educational Intervention

Group B: web-mobile app

EXPERIMENTAL

50 women will receive Lifestyle Educational Intervention (LEI) from research staff regarding a correct lifestyle during pregnancy and lactation through a digital tool (web-mobile app), previously developed.

Other: Lifestyle Educational Intervention

Control Group

NO INTERVENTION

50 women of the same age as the intervention group will be selected within the LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children (LIMIT) project cohort. The LIMIT protocol is registered on clinicaltrials.gov (NCT04960670)

Interventions

Lifestyle Educational Intervention OTHER

The Lifestyle Educational Intervention (LEI) consists of promoting a healthy lifestyle during pregnancy and breastfeeding. In particular, the contents concern: i). macro- and micronutrient requirements during pregnancy/breastfeeding; ii). definition of the concept of the food pyramid and healthy plate also considering aspects of food sustainability; iii). definition of the principles of food safety during pregnancy; iv). importance of maternal and infant sleep quality; v). importance of maternal physical activity during pregnancy and lactation; vi). psychological aspects regarding the mother-child dyad.

Also known as: LEI

Group A: frontal lessons; Group B: web-mobile app

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women (first trimester)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years;
• first trimester;
• parents' ability to speak and understand the Italian language;
• parents' ability to sign the informed consent and to fill in the questionnaires

You may not qualify if:

• age \< 18 years;
• diagnosis of chronic and/or eating disorders

Sponsors & Collaborators

• University of Pavia: lead

Related Links

• Project funded by the National Recovery and Resilience Plan (NRRP), ONFOOD Research Project, Spoke 5 - Lifelong and Nutrition.

MeSH Terms

Conditions

Breast Feeding; Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal

Central Study Contacts

Hellas Cena, Prof

CONTACT

+390382987542; hellas.cena@unipv.it

Rachele De Giuseppe, PhD

CONTACT

+390382987544; rachele.degiuseppe@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Quasi-experimental - controlled, non-randomized pilot study

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: February 16, 2024
• Study Start: March 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: November 30, 2025
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share