Women and Maternity: Development of a Nutritional Education Project

Pregnancy Clinical Trial

— MATER  

Official title:

Women and Maternity: Development of a Nutritional Education Project

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06264349
• Other study ID #: 05102023
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: February 2024
• Source: University of Pavia
• Contact: Hellas Cena, Prof
• Phone: +390382987542
• Email: hellas.cena[@]unipv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 30, 2025
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lactation
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).

External Links

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