LIMIT Early Adiposity Rebound in Children

Sponsor

University of Pavia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04960670

Collaborator

(none)

150

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Obesity Life Style Intestinal Microbiome	Other: Evaluation of microbiome and maternal/infant lifestyle

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

LIMIT (LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Dyads 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.

Arm

Intervention/Treatment

Dyads

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.

Outcome Measures

Primary Outcome Measures

Infant's intestinal microbiome assessment - relative abundance [0-48 month]
To investigate the infant's intestinal microbiome development (0-48 months) by identifying the relative abundance of the dominant microbes.
Infant's intestinal microbiome assessment - microbial diversity [0-48 month]
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the microbial diversity.
Infant's intestinal microbiome assessment - inter-individual variation [0-48 month]
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the inter-individual variation.

Secondary Outcome Measures

Adiposity rebound identification [0-48 month]
To identify adiposity rebound (AR) in children, discriminating between early AR and normal AR.
Infant intestinal microbiome and pre-gestational weight status [0-48 month]
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).
Infant intestinal microbiome and maternal weight gain [0-48 month]
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.
Infant intestinal microbiome and maternal dietary habits [0-48 month]
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.
Infant intestinal microbiome and maternal physical activity [0-48 month]
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.
Infant intestinal microbiome and mode of delivery [0-48 month]
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.
Infant intestinal microbiome and lactation [0-48 month]
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.
Infant intestinal microbiome and maternal endocrine disruptors chemicals (EDCs) exposure [0-48 month]
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.
Infant intestinal microbiome and dietary habits [0-48 month]
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.
Infant intestinal microbiome and infant sleeping habits [0-48 month]
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.
Predictive model [48-60 month]
To develop a predictive model for the early adiposity rebound risk taking into consideration all maternal and infant factors previously evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 48 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria: i) Infants of both sexes born to vaginal/caesarean delivery; ii) Gestational age: 37-42 weeks; iii) Italian-speaking parent; iv) 7 Ability of the parent/guardian to give informed consent; v) Ability of the mother to answer questionnaires.
Exclusion Criteria: i) Infants with genetic/congenital diseases; ii) Infants selected for another clinical study; iii) Infants hospitalized immediately after birth; iv) Presence of gestational diabetes; v) Presence of hyperthyroidism during pregnancy; vi) Parents refusing to sign the informed consent.