Status:

UNKNOWN

FACILITY: Feeding the fAmiLy: the Intergenerational approaCh to fIght obesiTY

Lead Sponsor:

Buzzi Children's Hospital

Collaborating Sponsors:

University of Pavia

Conditions:

Obesity

Obesity, Childhood

Eligibility:

All Genders

2+ years

Brief Summary

The FACILITY STUDY is aimed at evaluating maternal and children social, cultural, economic and lifestyle-related risk factors for the development of childhood overweight, obesity and early adiposity r...

Detailed Description

The FACILITY retrospective case-control study is conducted in one Italian hospital in Milan (Buzzi Children's Hospital) on children and adolescents (2-18 years old) with EAR and their mothers (≥ 18 ye...

Eligibility Criteria

Inclusion

  • Inclusion criteria (CASE GROUP)
  • For mothers:
  • Age ≥ 18 years old;
  • Admitted to the Department of Pediatrics, Buzzi Children's Hospital, Milan, Italy;
  • Written and signed informed consent.
  • For the children/adolescent:
  • Age \> 2 years and \< 18 years old;
  • Early adiposity rebound (\< 5 years of age);
  • Overweight (between 2-3 Z-score) and obesity (≥ 3 Z-score) diagnosis according to the CDC growth charts.
  • Admitted to the Department of Pediatrics, Buzzi Children's Hospital, Milan, Italy;
  • Mother and father/legal guardian had written and signed informed consent.
  • Inclusion criteria (CONTROL GROUP)
  • For mothers:
  • Age ≥ 18 years old;
  • Admitted to the Department of Pediatrics, Buzzi Children's Hospital, Milan, Italy;
  • Written and signed informed consent.
  • For the children/adolescent:
  • Age \> 2 years and \< 18 years old;
  • Early adiposity rebound (\< 5 years of age);
  • Admitted to the Department of Pediatrics, Buzzi Children's Hospital, Milan, Italy;
  • Mother and father/legal guardian had written and signed informed consent.
  • Exclusion criteria (CASE GROUP and CONTROL GROUP)
  • For the mothers:
  • Mother had not written and signed informed consent;
  • Inability to understand the Italian and English language.
  • For the children/adolescent:
  • Endocrine disorders (hypothyroidism, hypercortisolism, growth hormone deficiency);
  • Central nervous system damage (hypothalamic-pituitary damage because of surgery or trauma);
  • Genetic diseases either monogenic (leptin deficiency, MC4R mutation) or pleiotropic genetic syndromes (Prader-Willi, Bardet-Biedl);
  • Mother and father/legal guardian had not written and signed informed consent.

Exclusion

    Key Trial Info

    Start Date :

    December 1 2023

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2025

    Estimated Enrollment :

    269 Patients enrolled

    Trial Details

    Trial ID

    NCT06164340

    Start Date

    December 1 2023

    End Date

    December 1 2025

    Last Update

    December 18 2023

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