Chilean Maternal & Infant Cohort Study II (CHiMINCs-II)
- Conditions
- Body CompositionNutritional StatusBreast DensityMental Health Issue
- Interventions
- Other: Nutrition and mental health during pregnancy
- Registration Number
- NCT03920098
- Lead Sponsor
- Instituto de Nutrición y Tecnología de los Alimentos
- Brief Summary
The Chilean Maternal \& Infant Cohort Study II (ChiMINCs II) is an ongoing cohort that is part of the Chilean Maternal and Infant Nutrition Observatory of the South-East area of Santiago, Chile. In total, 1927 pregnant women beneficiaries of the public health systems and their offspring were recruited before 12 weeks of gestation and are followed across pregnancy (\<15, 26-28, and 35-37 weeks of gestation) and up to 2 years of age of their offspring. Two studies are currently nested in ChiMINCs II: 1) Breast Cancer Risk Assessment in Mothers (BRECAM) study, and 2) the ChiMINCs-COVID study. The primary objective of BRECAM study is to test the association between maternal metabolic indicators (i.e., insulin, glucose, IGF-1, and HbAc1 concentrations) at early pregnancy (i.e., \<15 and 26-28 weeks of gestation) and breast density 3 months after the cessation of lactation. For this purpose, we collect maternal obstetric, lifestyle, dietary intake, anthropometric, and biochemical information. The aim of the ChiMINCs-COVID study is to assess dietary-related risks and mental health problems derived from the COVID-19 pandemic and their influence on maternal and infant's health and nutrition. Thus, we collected detailed information on dietary behaviors, mental health and COVID-related information at each trimester, along with neonatal and infant nutritional information. The purpose of the present work is to describe the design, methods, and descriptive information at recruitment of ChiMINCs-II, also discussing the implications that this study can have to better understand maternal and infant nutrition and health during the COVID-19 era.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1927
- 18 or more years of age
- Gestation <15 weeks at first prenatal visit
- No intention to move outside the city of Santiago in the next to years
- High-risk pregnancy (i.e., preeclampsia, pre- existing diabetes)
- Pre-existing cancer or family history of breast cancer
- Intended to migrate from the public to the private health care system
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Mother-infant dyads Nutrition and mental health during pregnancy Mother-infant dyads
- Primary Outcome Measures
Name Time Method Breast absolute (AFGV) fibro-glandular volume measured by DXA technique Three months after breastfeeding cessation cm3
Gestational weight gain At delivery kg
Gestational Diabetes At delivery Percentage of mothers diagnosed
Edinburg Postnatal Depression Scale Through the gestation, up to 6 months Score
Pandemic Anxiety Scale Through the gestation, up the delivery Score
Pregnancy Risk Assessment Monitoring System Through the gestation, up the delivery Score
Breast absolute percentage (%FVG) of fibro-glandular volume measured by DXA technique Three months after breastfeeding cessation percentage
Glucose concentration Through the gestation, up the delivery mg/dL
Insulin concentration Through the gestation, up the delivery uIU/mL
- Secondary Outcome Measures
Name Time Method Offspring weight At 6 months of age g
Offspring head circumference At 6 months of age cm
Offspring body fat At 6 months of age Percentage
Offspring length At 6 months of age cm
Trial Locations
- Locations (1)
Corporación de Salud Municipal de Puente Alto
🇨🇱Santiago de Chile, Puente Alto, Chile