Women and Maternity: Development of a Nutritional Education Project
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Pavia
- Enrollment
- 100
- Primary Endpoint
- Gestational weight gain management
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Lifestyle Educational Intervention (Other)
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.
Intervention: Lifestyle Educational Intervention (Other)
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)
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).)
Investigators
Hellas Cena
Professor
University of Pavia