An observational study in Childhood Obesity, Life Style and Intestinal Microbiome, sponsored by University of Pavia. Not yet recruiting. Open to participants aged 1 Day to 48 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by University of Pavia · Observational
Childhood obesity is a strong predictor of adult obesity with health and economic consequences for the individual and society. Adiposity rebound (AR) is a rise in the Body Mass Index occurring between 3-7 years. Early adiposity rebound (EAR) occurs at a median age of 2 years and is a risk factor for later obesity. Events happening in "the first 1,000 days" play a role in obesity development. One of the key elements in this crucial time window is the gut microbiome, a highly dynamic organ that is sensitive to environmental exposure being linked to obesity development. Prenatal (dietary/lifestyle maternal factors and environmental exposure) and postnatal determinants (the type of feeding, sleep patterns, speed of growth) and environmental obesogenic pollutants may influence the infant microbial colonization, thus increasing the risk of EAR onset.
LIMIT will holistically identify the longitudinal interplay between the intestinal microbiome and infant/maternal nutritional and lifestyle habits, environmental factors exposure and anthropometric measurements, in children with AR vs EAR, driving new mechanistic insights to create an EAR predictive model.
The study will evaluate a group of 150 mother-infant pairs, during the first four years of life at different follow-up.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 150 is above the median of 135 across 1,283 observational studies indexed under Obesity.
Browse Obesity studies →University of Pavia is the lead sponsor of 141 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Mother and infant pairs.
Mother/infant pairs will be evaluated for anthropometric parameters, prenatal (dietary/lifestyle maternal factors)/postnatal determinants (type of feeding, sleep patterns, speed of growth) before discharge and after different follow-up after birth. Infant urinary and stool samples will be collected and stored. The infant adiposity rebound will be monitored.
Other: Evaluation of microbiome and maternal/infant lifestyle
Identification of the longitudinal interplay between the intestinal microbiome and infant/maternal nutritional and lifestyle habits, environmental factors exposure and anthropometric measurements, in children with adiposity rebound vs children with early adiposity rebound.
Infant's intestinal microbiome assessment - relative abundance
To investigate the infant's intestinal microbiome development (0-48 months) by identifying the relative abundance of the dominant microbes.
Time frame: 0-48 month
Infant's intestinal microbiome assessment - microbial diversity
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the microbial diversity.
Time frame: 0-48 month
Infant's intestinal microbiome assessment - inter-individual variation
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the inter-individual variation.
Time frame: 0-48 month
Adiposity rebound identification
To identify adiposity rebound (AR) in children, discriminating between early AR and normal AR.
Time frame: 0-48 month
Infant intestinal microbiome and pre-gestational weight status
To identify the longitudinal interplay between infant intestinal microbiome and pre-gestational weight status in children showing early adiposity rebound and in those showing normal adiposity rebound. In brief, maternal height (cm) and pre-pregnancy weight will be registered to calculate pre-gestational body mass index (BMI, Kg/m2).
Time frame: 0-48 month
Infant intestinal microbiome and maternal weight gain
To identify the longitudinal interplay between infant intestinal microbiome and maternal weight gain (Kg) during pregnancy in children showing early adiposity rebound and in those showing normal adiposity rebound.
Time frame: 0-48 month
Infant intestinal microbiome and maternal dietary habits
To identify the longitudinal interplay between infant intestinal microbiome, and maternal dietary habits in children showing early adiposity rebound and in those showing normal adiposity rebound. Dietary habits will be evaluated by using a previously validated questionnaire.
Time frame: 0-48 month
Infant intestinal microbiome and maternal physical activity
To identify the longitudinal interplay between infant intestinal microbiome and maternal physical activity during pregnancy in children showing early adiposity rebound and in those showing normal adiposity rebound. Physical activity will be evaluated by using a previously validated questionnaire.
Time frame: 0-48 month
Infant intestinal microbiome and mode of delivery
To identify the longitudinal interplay between infant intestinal microbiome and mode of delivery (vaginal delivery vs. caesarean section delivery) in children showing early adiposity rebound and in those showing normal adiposity rebound.
Time frame: 0-48 month
Infant intestinal microbiome and lactation
To identify the longitudinal interplay between infant intestinal microbiome and lactation (breastfeeding vs. formula feeding) in children showing early adiposity rebound and in those showing normal adiposity rebound.
Time frame: 0-48 month
Infant intestinal microbiome and maternal endocrine disruptors chemicals (EDCs) exposure
To identify the longitudinal interplay between infant intestinal microbiome and maternal EDCs exposure (e.g. BPA, phthalates) in children showing early adiposity rebound and in those showing normal adiposity rebound.
Time frame: 0-48 month
Infant intestinal microbiome and dietary habits
To identify the longitudinal interplay between infant intestinal microbiome and dietary habits in children showing early adiposity rebound and in those showing normal adiposity rebound. Infant dietary habits will be evaluated by using a previously validated questionnaire.
Time frame: 0-48 month
Infant intestinal microbiome and infant sleeping habits
To identify the longitudinal interplay between infant intestinal microbiome and sleeping habits, in children showing early adiposity rebound and in those showing normal adiposity rebound.
Time frame: 0-48 month
Predictive model
To develop a predictive model for the early adiposity rebound risk taking into consideration all maternal and infant factors previously evaluated.
Time frame: 48-60 month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pavia