LIMIT Early Adiposity Rebound in Children

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Infant's intestinal microbiome assessment - relative abundance [Срок оценки: 0-48 month]
• Infant's intestinal microbiome assessment - microbial diversity [Срок оценки: 0-48 month]
• Infant's intestinal microbiome assessment - inter-individual variation [Срок оценки: 0-48 month]

Вторичные конечные точки (11)

• Adiposity rebound identification [Срок оценки: 0-48 month]
• Infant intestinal microbiome and pre-gestational weight status [Срок оценки: 0-48 month]
• Infant intestinal microbiome and maternal weight gain [Срок оценки: 0-48 month]
• Infant intestinal microbiome and maternal dietary habits [Срок оценки: 0-48 month]
• Infant intestinal microbiome and maternal physical activity [Срок оценки: 0-48 month]
• Infant intestinal microbiome and mode of delivery [Срок оценки: 0-48 month]
• Infant intestinal microbiome and lactation [Срок оценки: 0-48 month]
• Infant intestinal microbiome and maternal endocrine disruptors chemicals (EDCs) exposure [Срок оценки: 0-48 month]
• Infant intestinal microbiome and dietary habits [Срок оценки: 0-48 month]
• Infant intestinal microbiome and infant sleeping habits [Срок оценки: 0-48 month]
• Predictive model [Срок оценки: 48-60 month]

Критерии участия

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04960670 · 10062021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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