LIMIT Early Adiposity Rebound in Children (LIMIT)

July 1, 2021 updated by: University of Pavia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mother and infant pairs.

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dyads
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant's intestinal microbiome assessment - relative abundance
Time Frame: 0-48 month
To investigate the infant's intestinal microbiome development (0-48 months) by identifying the relative abundance of the dominant microbes.
0-48 month
Infant's intestinal microbiome assessment - microbial diversity
Time Frame: 0-48 month
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the microbial diversity.
0-48 month
Infant's intestinal microbiome assessment - inter-individual variation
Time Frame: 0-48 month
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the inter-individual variation.
0-48 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adiposity rebound identification
Time Frame: 0-48 month
To identify adiposity rebound (AR) in children, discriminating between early AR and normal AR.
0-48 month
Infant intestinal microbiome and pre-gestational weight status
Time Frame: 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).
0-48 month
Infant intestinal microbiome and maternal weight gain
Time Frame: 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.
0-48 month
Infant intestinal microbiome and maternal dietary habits
Time Frame: 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.
0-48 month
Infant intestinal microbiome and maternal physical activity
Time Frame: 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.
0-48 month
Infant intestinal microbiome and mode of delivery
Time Frame: 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.
0-48 month
Infant intestinal microbiome and lactation
Time Frame: 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.
0-48 month
Infant intestinal microbiome and maternal endocrine disruptors chemicals (EDCs) exposure
Time Frame: 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.
0-48 month
Infant intestinal microbiome and dietary habits
Time Frame: 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.
0-48 month
Infant intestinal microbiome and infant sleeping habits
Time Frame: 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.
0-48 month
Predictive model
Time Frame: 48-60 month
To develop a predictive model for the early adiposity rebound risk taking into consideration all maternal and infant factors previously evaluated.
48-60 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Investigators

  • Principal Investigator: Rachele De Giuseppe, PhD, University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10062021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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