Clinical trial NCT03920098: Chilean Maternal & Infant Cohort Study II (CHiMINCs-II)
Official title: The Chilean Maternal and Infant Nutrition Cohort Study II
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Density
Body Composition
Nutritional Status
Mental Health Issue
Keywords: 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
Lead sponsor: Instituto de Nutrición y Tecnología de los Alimentos
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Catolica de Chile
name: Servicio de Salud Metropolitano Sur Oriente
First posted: 2019-04-18
Enrollment: 1927
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We identified pregnant women who received primary prenatal care within PHCC located in the South East area of Santiago. After, offspring of pregnant women were followed postnatally.

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.


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

Primary outcomes:
measure: Breast absolute (AFGV) fibro-glandular volume measured by DXA technique
timeFrame: Three months after breastfeeding cessation
measure: Breast absolute percentage (%FVG) of fibro-glandular volume measured by DXA technique
timeFrame: Three months after breastfeeding cessation
measure: Gestational weight gain
timeFrame: At delivery
measure: Gestational Diabetes
timeFrame: At delivery
measure: Pregnancy Risk Assessment Monitoring System
timeFrame: Through the gestation, up the delivery
measure: Edinburg Postnatal Depression Scale
timeFrame: Through the gestation, up to 6 months
measure: Glucose concentration
timeFrame: Through the gestation, up the delivery
measure: Insulin concentration
timeFrame: Through the gestation, up the delivery
measure: Pandemic Anxiety Scale
timeFrame: Through the gestation, up the delivery
Secondary outcomes:
measure: Offspring weight
timeFrame: At 6 months of age
measure: Offspring length
timeFrame: At 6 months of age
measure: Offspring head circumference
timeFrame: At 6 months of age
measure: Offspring body fat
timeFrame: At 6 months of age
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Corporación de Salud Municipal de Puente Alto
state: Puente Alto
Study officials:
affiliation: Instituto de Nutrición y Tecnología de Alimentos
name: María L Garmendia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Nutrition and Food Technology (INTA), University of Chile, Chile
name: Camila L Corvalán Aguilar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Nutrition and Food Technology (INTA), University of Chile, Chile
name: María F Mujica Coopman, PhD
role: PRINCIPAL_INVESTIGATOR
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