Chilean Maternal & Infant Cohort Study II (CHiMINCs-II)

Study Overview
=================
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.

Official Title
-----------------
The Chilean Maternal and Infant Nutrition Cohort Study II

Conditions
-----------------
Breast Density, Body Composition, Nutritional Status, Mental Health Issue

Intervention / Treatment
-----------------
* Other: Nutrition and mental health during pregnancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mother-infant dyads<br>Mother-infant dyads | Other: Nutrition and mental health during pregnancy<br>* Altered metabolic milieu is defined as a fasting glucose level >100 mg/dL at the first trimester of pregnancy by national guidelines. Altered metabolic milieu during the second trimester (24-28 weeks of pregnancy) is defined as a fasting glucose levels > 92 mg/dL and/or plasma glucose levels > 153 mg/dL two hours after load in the oral glucose tolerance test according to ADA guidelines or a fasting glucose >100 mg/dL and/or > 140 mg/dL two hours after load in the oral glucose tolerance test according to national guidelines. The COVID-19 pandemic is considered as a natural nutritional and mental health exposure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast absolute (AFGV) fibro-glandular volume measured by DXA technique | cm3 | Three months after breastfeeding cessation | 
| Breast absolute percentage (%FVG) of fibro-glandular volume measured by DXA technique | percentage | Three months after breastfeeding cessation | 
| Gestational weight gain | kg | At delivery | 
| Gestational Diabetes | Percentage of mothers diagnosed | At delivery | 
| Pregnancy Risk Assessment Monitoring System | Score | Through the gestation, up the delivery | 
| Edinburg Postnatal Depression Scale | Score | Through the gestation, up to 6 months | 
| Glucose concentration | mg/dL | Through the gestation, up the delivery | 
| Insulin concentration | uIU/mL | Through the gestation, up the delivery | 
| Pandemic Anxiety Scale | Score | Through the gestation, up the delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Offspring weight | g | At 6 months of age | 
| Offspring length | cm | At 6 months of age | 
| Offspring head circumference | cm | At 6 months of age | 
| Offspring body fat | Percentage | At 6 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast densities, Breast neoplasms, Glucose metabolism disorders, Diabetes, gestational, Pregnancy, Nutritional status, Mental health, Body composition, Growth and development, Primary Health Care, Dual-energy X-ray Absorptiometry, Latin America, Chile