ClinConnect ClinConnect Logo
Search / Trial NCT06164340

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

Launched by BUZZI CHILDREN'S HOSPITAL · Dec 1, 2023

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

Overweight Obesity Childhood Obesity Continuum Of Care Maternal Health Child Health Policy Food Policies Adiposity Rebound

ClinConnect Summary

The FACILITY study is a research project designed to understand the factors that contribute to childhood obesity and overweight. Specifically, it looks at various social, cultural, economic, and lifestyle influences on both mothers and children to see how they affect a child's weight and health. This study will include two parts: the first part involves gathering information from families at a specific time, while the second part will compare different cases to see what might lead to weight issues in children.

To participate in this study, mothers must be at least 18 years old and admitted to the Buzzi Children's Hospital in Milan, Italy, along with their children aged between 2 and 18 years who are identified as overweight or obese. Both parents or guardians must give their consent for the child to participate. Participants can expect to share their experiences and information about their lifestyle and health, which will help researchers better understand and address childhood obesity. It's important to note that certain health conditions, like hormonal disorders or genetic diseases, will prevent some families from participating.

Gender

ALL

Eligibility criteria

  • 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.

About Buzzi Children's Hospital

Buzzi Children's Hospital is a leading pediatric healthcare institution dedicated to advancing the well-being of children through innovative clinical research and compassionate care. With a commitment to excellence, the hospital conducts a range of clinical trials aimed at improving treatment outcomes and understanding childhood diseases. Buzzi Children's Hospital collaborates with various stakeholders, including academic institutions and pharmaceutical companies, to foster groundbreaking research initiatives. Its multidisciplinary team of healthcare professionals ensures the highest standards of safety and ethical practices, making it a trusted partner in pediatric clinical trials.

Locations

Patients applied

0 patients applied

Trial Officials

Hellas Cena

Principal Investigator

Laboratory of Dietetics and Clinical Nutrition, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, via Bassi 21, 27100 Pavia, Italy. Clinical nutrition Unit, General Medicine, ICS Maugeri IRCCS, 27100 Pavia, Italy

Valeria Calcaterra

Principal Investigator

Pediatric Department, Buzzi Children's Hospital, 20154 Milano, Italy. Department of Internal Medicine and Therapeutics, University of Pavia, 27100 Pavia, Italy.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported