LIMIT Early Adiposity Rebound in Children

Not yet recruiting

• Conditions: Life Style; Intestinal Microbiome; Childhood Obesity
• Interventions: Other: Evaluation of microbiome and maternal/infant lifestyle

• Registration Number: NCT04960670
• Lead Sponsor: University of Pavia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-10
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Study First Posted: 2021-07-14
• Last Update Posted: 2021-07-14
• Study Start: 2021-12-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dyads	Evaluation of microbiome and maternal/infant lifestyle	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.

Primary Outcome Measures

Name	Time	Method
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 - inter-individual variation	0-48 month	To investigate the infant's intestinal microbiome development (0-48 months) by assessing the inter-individual variation.
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.

Secondary Outcome Measures

Name	Time	Method
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 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.
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.
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 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.
Adiposity rebound identification	0-48 month	To identify adiposity rebound (AR) in children, discriminating between early AR and normal AR.
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.