LIMIT Early Adiposity Rebound in Children
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-48
SponsorUniversity of Pavia
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Mother and infant pairs.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Evaluation of microbiome and maternal/infant lifestyle
Other interventionIdentification 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Dyads1 intervention
Trial outcomes
Primary outcomes
1
Infant's intestinal microbiome assessment - relative abundance
To investigate the infant's intestinal microbiome development (0-48 months) by identifying the relative abundance of the dominant microbes.
Time frame
0-48 month2
Infant's intestinal microbiome assessment - microbial diversity
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the microbial diversity.
Time frame
0-48 month3
Infant's intestinal microbiome assessment - inter-individual variation
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the inter-individual variation.
Time frame
0-48 monthSecondary outcomes
1
Adiposity rebound identification
To identify adiposity rebound (AR) in children, discriminating between early AR and normal AR.
Time frame
0-48 month2
Infant intestinal microbiome and pre-gestational weight status
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).
Time frame
0-48 month3
Infant intestinal microbiome and maternal weight gain
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.
Time frame
0-48 month4
Infant intestinal microbiome and maternal dietary habits
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.
Time frame
0-48 monthLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: