LIMIT Early Adiposity Rebound in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Evaluation of microbiome and maternal/infant lifestyle.
- Who it may be relevant to
- Registry conditions: Childhood Obesity, Life Style, Intestinal Microbiome. Basic parameters: 1 Day — 48 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
LIMIT (LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children
Overview
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
- 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.
Primary outcome measures
- Infant's intestinal microbiome assessment - relative abundance [Time frame: 0-48 month]
- Infant's intestinal microbiome assessment - microbial diversity [Time frame: 0-48 month]
- Infant's intestinal microbiome assessment - inter-individual variation [Time frame: 0-48 month]
Secondary outcome measures (11)
- Adiposity rebound identification [Time frame: 0-48 month]
- Infant intestinal microbiome and pre-gestational weight status [Time frame: 0-48 month]
- Infant intestinal microbiome and maternal weight gain [Time frame: 0-48 month]
- Infant intestinal microbiome and maternal dietary habits [Time frame: 0-48 month]
- Infant intestinal microbiome and maternal physical activity [Time frame: 0-48 month]
- Infant intestinal microbiome and mode of delivery [Time frame: 0-48 month]
- Infant intestinal microbiome and lactation [Time frame: 0-48 month]
- Infant intestinal microbiome and maternal endocrine disruptors chemicals (EDCs) exposure [Time frame: 0-48 month]
- Infant intestinal microbiome and dietary habits [Time frame: 0-48 month]
- Infant intestinal microbiome and infant sleeping habits [Time frame: 0-48 month]
- Predictive model [Time frame: 48-60 month]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04960670 · 10062021