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Search / Trial NCT06179381

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

Launched by BUZZI CHILDREN'S HOSPITAL · Dec 11, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Overweight Obesity Childhood Obesity Continuum Of Care Maternal Health Child Health Adiposity Rebound

ClinConnect Summary

The FACILITY study is designed to understand the social, cultural, economic, and lifestyle factors that contribute to obesity in children and their mothers. Researchers want to learn more about why some children become overweight and how early changes in body fat can happen. The study will take place at Buzzi Children's Hospital in Milan, Italy, and includes two parts: one where information is gathered at a single point in time and another that looks back at previous cases.

To participate in this study, mothers must be at least 18 years old and able to give their written consent. They also need to be admitted to the hospital. Children eligible for the study should be between 2 and 18 years old and also admitted to the hospital, with consent from their parents or guardians. However, certain children with specific medical conditions, like hormonal or genetic disorders, will not be included. Participants can expect to share information about their daily lives and health, helping researchers better understand how to tackle obesity in families.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria for mothers:
  • Age ≥ 18 years old;
  • Admitted to the Department of Pediatrics, Buzzi Children's Hospital, Milan, Italy;
  • Written and signed informed consent.
  • Exclusion Criteria for mothers:
  • Mother had not written and signed informed consent;
  • Inability to understand the Italian and English language.
  • Inclusion Criteria for children:
  • Age \> 2 years and \< 18 years old;
  • 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 for children:
  • 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

Valeria Calcaterra, Dr

Principal Investigator

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

Hellas Cena, Dr

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported