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LIMIT Early Adiposity Rebound in Children

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04960670
Acronym
LIMIT
Enrollment
150
Registered
2021-07-14
Start date
2021-12-01
Completion date
2026-12-31
Last updated
2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Intestinal Microbiome, Life Style

Keywords

childhood obesity, maternal lifestyle, gut microbiome, adiposity rebound, fetal programming, first thousand days, pregnancy, breastfeeding, children nutrition, endocrine disruptors chemicals

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.

Interventions

OTHEREvaluation 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.

Sponsors

University of Pavia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 48 Months
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Infant's intestinal microbiome assessment - relative abundance0-48 monthTo 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 diversity0-48 monthTo investigate the infant's intestinal microbiome development (0-48 months) by assessing the microbial diversity.
Infant's intestinal microbiome assessment - inter-individual variation0-48 monthTo investigate the infant's intestinal microbiome development (0-48 months) by assessing the inter-individual variation.

Secondary

MeasureTime frameDescription
Infant intestinal microbiome and maternal dietary habits0-48 monthTo 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 activity0-48 monthTo 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 delivery0-48 monthTo 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 lactation0-48 monthTo 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.
Adiposity rebound identification0-48 monthTo identify adiposity rebound (AR) in children, discriminating between early AR and normal AR.
Infant intestinal microbiome and dietary habits0-48 monthTo 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 habits0-48 monthTo 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 model48-60 monthTo develop a predictive model for the early adiposity rebound risk taking into consideration all maternal and infant factors previously evaluated.
Infant intestinal microbiome and maternal endocrine disruptors chemicals (EDCs) exposure0-48 monthTo 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 pre-gestational weight status0-48 monthTo 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 gain0-48 monthTo 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.

Contacts

Primary ContactIlaria Di Napoli, Dr
ilaria.dinapoli@unipv.it+390382987536
Backup ContactHellas Cena, Prof
hellas.cena@unipv.it+390382987542

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026