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

University of Pavia

Status: Not yet enrolling

Conditions: Lactation; Pregnancy

Treatments: Other: Lifestyle Educational Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06264349

05102023

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Group A: frontal lessons

Experimental group

Description:

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.

Treatment:

Other: Lifestyle Educational Intervention

Group B: web-mobile app

Experimental group

Description:

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.

Treatment:

Other: Lifestyle Educational Intervention

Control Group

No Intervention group

Description:

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)