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

NCT06179381 | Unknown

• 2 other identifiers: 02102023CUP: F13C22001210007
• Study Type: observational
• Target: 269
• Locations: 0 countries
• Sites: N/A

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 rebound (EAR). This study consists of two phases: a cross-sectional phase and a retrospective case-control study.

Conditions

Obesity; Child Obesity; Maternal Obesity; Overweight

Keywords

Overweight; Obesity; Childhood obesity; Continuum of Care; Maternal health; Child Health; Adiposity rebound

Outcome Measures

Primary Outcomes (1)

• Prevalence of childhood overweight and obesity

  Number of children with overweight or obesity divided by the total number of children. Diagnosis: BMI percentile in the Center for Diseases Control (CDC) growth chart (overweight: 85th-95th percentile/2-3 Z score; obesity ≥ 95th percentile/≥ 3 Z score).

  Day 1

Secondary Outcomes (16)

• Mediterranean diet adherence for dyads

  Day 1

• Dietary patterns of mothers

  Day 1

• Physical activity for dyads

  Day 1

• Sleep quality for dyads

  Day 1

• Smoking habits for dyads

  Day 1

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To the patients (mother-child dyads) coming to the outpatient facilities (of the Department of Pediatrics, Buzzi Children's Hospital, Milan) and eligible in accordance with the inclusion and exclusion criteria will be proposed to participate in the study and will be given the informative material. For children and adolescents, the informed consent will be read and signed by the parents, who are the legal guardians. After the acquisition of the informed consent, the clinic information will be collected as the protocol procedure.

You may qualify if:

• Age ≥ 18 years old;
• Admitted to the Department of Pediatrics, Buzzi Children's Hospital, Milan, Italy;
• Written and signed informed consent.

You may not qualify if:

• Mother had not written and signed informed consent;
• Inability to understand the Italian and English language.
• 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.
• 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.

Sponsors & Collaborators

• Buzzi Children's Hospital: lead
• University of Pavia: collaborator

Related Publications (1)

• Vincenti A, Calcaterra V, Santero S, Viroli G, Di Napoli I, Biino G, Daconto L, Cusumano M, Zuccotti G, Cena H. FACILITY: feeding the family-the intergenerational approach to fight obesity, a cross-sectional study protocol. Front Pediatr. 2025 Mar 31;13:1450324. doi: 10.3389/fped.2025.1450324. eCollection 2025.

  PMID: 40230801 DERIVED

MeSH Terms

Conditions

Obesity; Pediatric Obesity; Pregnancy in Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Valeria Calcaterra, Dr

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

  PRINCIPAL INVESTIGATOR

• Hellas Cena, Dr

  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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Vincenti, Dr

CONTACT

+39 3898292390; alessandra.vincenti@unipv.it

Valeria Calcaterra, Dr

CONTACT

+39 3289440188; valeria.calcaterra@unipv.it

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 21, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 2, 2024

Record last verified: 2023-12