LIMIT Early Adiposity Rebound in Children

Childhood Obesity Clinical Trial

— LIMIT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04960670
• Other study ID #: 10062021
• Status: Not yet recruiting
• Start date: December 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2021
• Source: University of Pavia
• Contact: Ilaria Di Napoli, Dr
• Phone: +390382987536
• Email: ilaria.dinapoli[@]unipv.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 48 Months

Eligibility

• 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.

Related Conditions & MeSH terms

• Childhood Obesity
• Intestinal Microbiome
• Life Style
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-48 month
Primary	Infant's intestinal microbiome assessment - microbial diversity	To investigate the infant's intestinal microbiome development (0-48 months) by assessing the microbial diversity.	0-48 month
Primary	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.	0-48 month
Secondary	Adiposity rebound identification	To identify adiposity rebound (AR) in children, discriminating between early AR and normal AR.	0-48 month
Secondary	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).	0-48 month
Secondary	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.	0-48 month
Secondary	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.	0-48 month
Secondary	Infant intestinal microbiome and maternal physical activity	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
Secondary	Infant intestinal microbiome and mode of delivery	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
Secondary	Infant intestinal microbiome and lactation	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
Secondary	Infant intestinal microbiome and maternal endocrine disruptors chemicals (EDCs) exposure	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
Secondary	Infant intestinal microbiome and dietary habits	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
Secondary	Infant intestinal microbiome and infant sleeping habits	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
Secondary	Predictive model	To develop a predictive model for the early adiposity rebound risk taking into consideration all maternal and infant factors previously evaluated.	48-60 month