Childhood ObesityLIMITNCT04960670
LIMIT Early Adiposity Rebound in Children
An observational study of Childhood Obesity and Life Style, run by University of Pavia.
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. Read more about this study
- Who is it for?
- Ages 1 day to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Life Style, Intestinal Microbiome
- What is being tested?
- Evaluation of microbiome and maternal/infant lifestyle
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Mother and infant pairs.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Childhood Obesity, Life Style, Intestinal Microbiome
- Being tested
- Evaluation of microbiome and maternal/infant lifestyle
- Keywords
- childhood obesity, maternal lifestyle, gut microbiome, adiposity rebound, fetal programming, first thousand days, pregnancy, breastfeeding, children nutrition, endocrine disruptors chemicals
- Medical subject headings
- Pediatric Obesity, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of microbiome and maternal/infant lifestyleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Evaluation of microbiome and maternal/infant lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-48 month
Infant's intestinal microbiome assessment - microbial diversity
To investigate the infant's intestinal microbiome development (0-48 months) by assessing the microbial diversity.
Measured: 0-48 month
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.
Measured: 0-48 month
Secondary outcomes (11)
Adiposity rebound identification
To identify adiposity rebound (AR) in children, discriminating between early AR and normal AR.
Measured: 0-48 month
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).
Measured: 0-48 month
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.
Measured: 0-48 month
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.
Measured: 0-48 month
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.
Measured: 0-48 month
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.
Measured: 0-48 month
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.
Measured: 0-48 month
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.
Measured: 0-48 month
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.
Measured: 0-48 month
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.
Measured: 0-48 month
Predictive model
To develop a predictive model for the early adiposity rebound risk taking into consideration all maternal and infant factors previously evaluated.
Measured: 48-60 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Dec 2021 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachele De Giuseppe, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960670
- Sponsor's protocol ID
- 10062021
- Acronym
- LIMIT
- Status last verified
- Jul 2021
- First submitted
- 10 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIMIT (LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children
- ClinicalTrials.gov ID
- NCT04960670
- Acronym / sponsor ID
- LIMIT / 10062021
- Conditions
- Childhood Obesity, Life Style, Intestinal Microbiome
- Keywords
- childhood obesity, maternal lifestyle, gut microbiome, adiposity rebound, fetal programming, first thousand days, pregnancy, breastfeeding
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dyads | – | Other: Evaluation of microbiome and maternal/infant lifestyleMother/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. |
Who may qualify
- Ages
- 1 day to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Mother and infant pairs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of microbiome and maternal/infant lifestyleIdentification 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. | Other | Dyads |
Primary outcome
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.
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.
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachele De Giuseppe, PhD principal investigator
University of Pavia
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity and Life Style, run by University of Pavia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Di Napoli, Dr (+390382987536, ilaria.dinapoli@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant's intestinal microbiome assessment - relative abundance (time frame: 0-48 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.