Women and Maternity: Development of a Nutritional Education Project (MATER)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Lactation
• Intervention / Treatment: Other: Lifestyle Educational Intervention

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hellas Cena, Prof; Phone Number: +390382987542; Email: hellas.cena@unipv.it
• Study Contact Backup: Name: Rachele De Giuseppe, PhD; Phone Number: +390382987544; Email: rachele.degiuseppe@unipv.it

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: frontal lessons; 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; 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.; Other Names: LEI
Experimental: Group B: web-mobile app; 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; 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.; Other Names: LEI
No Intervention: Control Group; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional aspects evaluation during pregnancy and lactation	Evaluation of the LEI program effectiveness on nutritional aspects. In particular, maternal adherence to the Mediterranean Diet as well as maternal nutritional knowledge will be assessed by meaning of previously validated questionnaires 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).	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	Evaluation of the LEI program effectiveness on physical activity. In particular, to investigate physical activity patterns, a section of a previously developed and validated questionnaire on an Italian youth population was adapted and administered to our adult participants by deleting physical activities in the school environment. This adapted version was also pre-tested on a sample of 24 subjects and revised accordingly. All answers were structured to quantify the time spent weekly in physical activity, including the activities spent during free time and screen time. The questionnaire was composed of 5 multiple-choice questions that followed a Likert scale format comprising 4 choices ("Always", "Often", "Sometimes", and "Never") corresponding to a score between 0 to 3, where the highest score suggested the healthiest habit.	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	Evaluation of the LEI program effectiveness on smoking habits. In particular, smoking habits will be monitored through interviews, and the number of smoked cigarette packs per year will be documented. Participants will be categorized as those who had never smoked, quit smoking before or during pregnancy, or started or kept smoking during pregnancy and/or 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.	The Iowa Infant Feeding Attitude Scale (IIFAS) was used to assess the maternal attitude towards infant feeding methods and to predict breastfeeding intention and exclusivity. In brief, the IIFAS is a standardized interview questionnaire on participants' characteristics and habits (age, residence, education, self-assessed socioeconomic status, relationship status, work before pregnancy, back to work after maternity leave, mode of delivery, parity, way of feeding previous babies, planned way of feeding this newborn)	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).

Collaborators and Investigators

• Sponsor: University of Pavia

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): May 15, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Health; Lifestyle; Dietary habits; First one-thousand days
• Other Study ID Numbers: 05102023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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