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Clinical Trials/NCT06264349
NCT06264349
Not yet recruiting
Not Applicable

Women and Maternity: Development of a Nutritional Education Project

University of Pavia0 sites100 target enrollmentMarch 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
University of Pavia
Enrollment
100
Primary Endpoint
Gestational weight gain management
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2024
End Date
November 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hellas Cena

Professor

University of Pavia

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Gestational weight gain management

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

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).

Secondary Outcomes

  • 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).)
  • 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).)
  • 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).)
  • 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).)

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