Clinical trial NCT04960670: LIMIT Early Adiposity Rebound in Children
Official title: LIMIT (LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Childhood Obesity
Life Style
Intestinal Microbiome
Keywords: childhood obesity
maternal lifestyle
gut microbiome
adiposity rebound
fetal programming
first thousand days
pregnancy
breastfeeding
children nutrition
endocrine disruptors chemicals
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mother and infant pairs.

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.


Eligibility criteria: * 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.

Primary outcomes:
measure: Infant's intestinal microbiome assessment - relative abundance
timeFrame: 0-48 month
measure: Infant's intestinal microbiome assessment - microbial diversity
timeFrame: 0-48 month
measure: Infant's intestinal microbiome assessment - inter-individual variation
timeFrame: 0-48 month
Secondary outcomes:
measure: Adiposity rebound identification
timeFrame: 0-48 month
measure: Infant intestinal microbiome and pre-gestational weight status
timeFrame: 0-48 month
measure: Infant intestinal microbiome and maternal weight gain
timeFrame: 0-48 month
measure: Infant intestinal microbiome and maternal dietary habits
timeFrame: 0-48 month
measure: Infant intestinal microbiome and maternal physical activity
timeFrame: 0-48 month
measure: Infant intestinal microbiome and mode of delivery
timeFrame: 0-48 month
measure: Infant intestinal microbiome and lactation
timeFrame: 0-48 month
measure: Infant intestinal microbiome and maternal endocrine disruptors chemicals (EDCs) exposure
timeFrame: 0-48 month
measure: Infant intestinal microbiome and dietary habits
timeFrame: 0-48 month
measure: Infant intestinal microbiome and infant sleeping habits
timeFrame: 0-48 month
measure: Predictive model
timeFrame: 48-60 month
Other outcomes:
Locations:
Study officials:
affiliation: University of Pavia
name: Rachele De Giuseppe, PhD
role: PRINCIPAL_INVESTIGATOR
References: