ObesityFACILITYNCT06179381
Feeding the fAmiLy: the Intergenerational approaCh to fIght obesiTY (FACILITY)
An observational study of Obesity and Child Obesity, run by Buzzi Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Obesity, Child Obesity, Maternal Obesity
- How many people
- 269 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years old;
- Admitted to the Department of Pediatrics, Buzzi Children's Hospital, Milan, Italy;
- Written and signed informed consent.
- 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.
Who cannot join
- Mother had not written and signed informed consent;
- Inability to understand the Italian and English language.
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: FACILITY (Feeding the fAmiLy: the Intergenerational approaCh to fIght obesiTY)
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.
Read the detailed description
The FACILITY cross-sectional study is conducted in the Buzzi Children's Hospital in Milan on children and adolescents (2-18 years old) and their mothers (≥ 18 years old). The estimated duration is 24 months.
The primary objective of the FACILITY cross-sectional is the assessment of the nutritional and socioeconomic status of mother-child dyads attending a pediatric outpatient clinic in the city of Milan, Italy (mapping). Therefore, the primary endpoint is to define the overweight and obesity prevalence in multiethnic mother-child dyads attending a pediatric outpatient clinic in the city of Milan, Italy.
The secondary objectives are: 1) Assessment of lifestyle factors and their impact on the health status of the target population. 2) Assessment of socioeconomic and cultural factors and their impact on the health status of the target population. Thus, the secondary endpoints are: 1) Impact of lifestyle on overweight and obesity in children/adolescents. 2) Impact of socio-economic-cultural factors on overweight and obesity in children/adolescents.
To 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.
On eligible subject different variables will be measured.
For mothers - Regarding lifestyle and health factors, dietary patterns will be evaluated through the Mediterranean diet (MEDI-LITE) questionnaire and through a structured interview; physical activity will be evaluated with the International Physical Activity Questionnaire (IPAQ); sleep quality will be investigated with Pittsburgh Sleep Quality Index (PSQI) questionnaire; smoking habits and alcohol consumption will be evaluated through a structured interview and anthropometric variables will include weight, height and waist circumference.
Variables referred to socio-economic and cultural factors include family relationships that will be assessed through the Child-Parent Relationship Scale - Short Form (CPRS-SF) questionnaire; the personal social capital will be investigated through the Personal Social Capital Scale (PSCS-8) questionnaire; the socio-economic status (SES) will be derived from demographic data; the neighborhood food environment characteristics, as well as the local built and social environment characteristics, will be evaluated through mapping and spatial analysis; social participation will be explored through structured interviews.
For children/adolescents - Dietary patterns will be evaluated through the Mediterranean Diet Quality Index for Children and Adolescents (KIDMED) questionnaire; physical activity will be evaluated with a structured interview for children aged 2-14 years old or with the International Physical Activity Questionnaire for Adolescents (IPAQ-A) for children aged 15-17 years old. Similarly, structured interviews will be conducted to assess sedentary screen time and sleep quality; smoking habits and alcohol consumption will be evaluated in adolescents (children aged 12-18 years old) through a structured interview and binge eating symptoms (i.e., sneaking, hiding, or hoarding food, eating in the absence of hunger) will be investigated with a structured interview. Anthropometric variables will include weight, height, adiposity rebound and waist circumference.
- Conditions
- Obesity, Child Obesity, Maternal Obesity, Overweight
- Keywords
- Overweight, Obesity, Childhood obesity, Continuum of Care, Maternal health, Child Health, Adiposity rebound
- Medical subject headings
- Obesity, Pediatric Obesity, Pregnancy in Obesity, Overweight
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
Secondary outcomes (16)
Mediterranean diet adherence for dyads
For mothers, Medi-Lite questionnaire (total score ranges between 0-18. A higher score represents higher adherence to the Mediterranean diet);
For children, KIDMED questionnaire (total score ranges between 0-12. A higher score indicates higher adherence to the Mediterranean diet).
Measured: Day 1
Dietary patterns of mothers
Structured interview (mother's perception of her current diet, possible dietary restrictions, traditional food/dishes consumed, influence of living in Italy on the dietary pattern).
Measured: Day 1
Physical activity for dyads
For mothers, International Physical Activity Questionnaire short form (the questionnaire provides the total weekly Physical Activity level in metabolic equivalents (METs)/min/week; the categories are: low, moderate and vigorous physical activity).
For children aged ≤ 14 years old: structured interview (minutes and/or hours of daily physical activity). Results will be compared with WHO guidelines.
For children aged 15 - 17 years old, International Physical Activity Questionnaire for Adolescents (the questionnaire provides the total weekly Physical Activity level in metabolic equivalents (METs)/min/week; the categories are: low, moderate and vigorous physical activity).
Measured: Day 1
Sleep quality for dyads
For mothers, Pittsburgh Sleep Quality Index questionnaire (total score ranges between 0-21. A higher score represents lower sleep quality).
For children, structured interview (sleep and wake-up times, sleep regularity, average number of hours of sleep per night, difficulty falling asleep, daytime sleepiness).
Measured: Day 1
Smoking habits for dyads
For mothers and for children aged 12 - 18 years old, structured interview: current smoking of traditional tobacco or electronic cigarettes or heated tobacco products (HTP) per day; smoking history. Based on smoking declaration, participants will be categorized as: never smoker (i.e., never smoked), past smoker (i.e., current nonsmoker), current smoke (i.e., current user of tobacco or electronic cigarette or HTP products)).
Measured: Day 1
Alcohol consumption for dyads
For mothers and for children aged 12 - 18 years old, structured interview: current weekly alcohol consumption. Based on alcohol consumption declaration, participants will be categorized as: abstainers (i.e., subjects who do not drink alcohol, zero Units of Alcohol (U.A.)), occasional drinkers (i.e., subjects who drink less than 1 U.A./week), and daily drinkers (i.e., subjects who regularly drink alcohol, more than 1 U.A./week).
Measured: Day 1
Sedentary screen time for children
For children, structured interview (in free time on school days: evaluation of time spent on computer, TV/movie, cell phone in leisure time on the weekend: evaluation of time spent on computer, TV/movie, cell phone).
Measured: Day 1
Socio-economic status for mothers
For mothers: education level (none, elementary, middle school, high school, degree), nationality, profession/job, income, and housing status (owned, rented, sub-rented, social housing, guest, other, don't answer).
Measured: Day 1
Family relationships for mothers
For mothers, Child-Parent Relationship Scale - Short Form questionnaire (higher scores indicates greater challenges in family relationships). Total score is calculated by sum. Higher total score for the closeness scale indicates higher closeness between mother and child. Higher total score for the conflict scale indicates a more conflictual relationship between mother and child.
Measured: Day 1
Personal social capital for mothers
For mothers, Personal Social Capital Scale questionnaire (higher scores represents higher personal social capital). The summation of the two subscale (bonding capital score and bridging capital score) yield to the total social capital score. Higher total score indicates a higher social capital score.
Measured: Day 1
Neighborhood food environment for mothers
For mothers, spatial analysis of data on location of food stores types
Measured: Day 1
Social environment for mothers
For mothers,spatial analysis of cultural services
Measured: Day 1
Social participation for mothers
For mothers, structured interview (activities in which the mother takes part: type and frequency of cultural, religious and recreational activities).
Measured: Day 1
Weight of dyads
weight (kg)
Measured: Day 1
Height of dyads
height (m)
Measured: Day 1
Waist circumference of dyads
waist circumference (cm)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buzzi Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia
- Responsible party
- Principal investigator, Valeria Calcaterra, Buzzi Children's Hospital
- Investigators
- 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, ItalyHellas 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179381
- Sponsor's protocol ID
- 02102023
- Other IDs
- CUP: F13C22001210007
- Acronym
- FACILITY
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40230801
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FACILITY (Feeding the fAmiLy: the Intergenerational approaCh to fIght obesiTY)
- ClinicalTrials.gov ID
- NCT06179381
- Acronym / sponsor ID
- FACILITY / 02102023
- Conditions
- Obesity, Child Obesity, Maternal Obesity, Overweight
- Keywords
- Overweight, Obesity, Childhood obesity, Continuum of Care, Maternal health, Child Health, Adiposity rebound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 269 participants (estimated)
- Lead sponsor
- Buzzi Children's HospitalUniversity, hospital or other
- Collaborators
- University of Pavia
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Dec 2023 (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.
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.
Detailed description
The FACILITY cross-sectional study is conducted in the Buzzi Children's Hospital in Milan on children and adolescents (2-18 years old) and their mothers (≥ 18 years old). The estimated duration is 24 months.
The primary objective of the FACILITY cross-sectional is the assessment of the nutritional and socioeconomic status of mother-child dyads attending a pediatric outpatient clinic in the city of Milan, Italy (mapping). Therefore, the primary endpoint is to define the overweight and obesity prevalence in multiethnic mother-child dyads attending a pediatric outpatient clinic in the city of Milan, Italy.
The secondary objectives are: 1) Assessment of lifestyle factors and their impact on the health status of the target population. 2) Assessment of socioeconomic and cultural factors and their impact on the health status of the target population. Thus, the secondary endpoints are: 1) Impact of lifestyle on overweight and obesity in children/adolescents. 2) Impact of socio-economic-cultural factors on overweight and obesity in children/adolescents.
To 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.
On eligible subject different variables will be measured.
For mothers - Regarding lifestyle and health factors, dietary patterns will be evaluated through the Mediterranean diet (MEDI-LITE) questionnaire and through a structured interview; physical activity will be evaluated with the International Physical Activity Questionnaire (IPAQ); sleep quality will be investigated with Pittsburgh Sleep Quality Index (PSQI) questionnaire; smoking habits and alcohol consumption will be evaluated through a structured interview and anthropometric variables will include weight, height and waist circumference.
Variables referred to socio-economic and cultural factors include family relationships that will be assessed through the Child-Parent Relationship Scale - Short Form (CPRS-SF) questionnaire; the personal social capital will be investigated through the Personal Social Capital Scale (PSCS-8) questionnaire; the socio-economic status (SES) will be derived from demographic data; the neighborhood food environment characteristics, as well as the local built and social environment characteristics, will be evaluated through mapping and spatial analysis; social participation will be explored through structured interviews.
For children/adolescents - Dietary patterns will be evaluated through the Mediterranean Diet Quality Index for Children and Adolescents (KIDMED) questionnaire; physical activity will be evaluated with a structured interview for children aged 2-14 years old or with the International Physical Activity Questionnaire for Adolescents (IPAQ-A) for children aged 15-17 years old. Similarly, structured interviews will be conducted to assess sedentary screen time and sleep quality; smoking habits and alcohol consumption will be evaluated in adolescents (children aged 12-18 years old) through a structured interview and binge eating symptoms (i.e., sneaking, hiding, or hoarding food, eating in the absence of hunger) will be investigated with a structured interview. Anthropometric variables will include weight, height, adiposity rebound and waist circumference.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age ≥ 18 years old;
- Admitted to the Department of Pediatrics, Buzzi Children's Hospital, Milan, Italy;
- Written and signed informed consent.
- Age > 2 years and < 18 years old;
- Admitted to the Department of Pediatrics, Buzzi Children's Hospital, Milan, Italy;
Key exclusion criteria (6 listed)
- Mother had not written and signed informed consent;
- Inability to understand the Italian and English language.
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of childhood overweight and obesity
Time frame: Day 1
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).
16 secondary outcomes
Mediterranean diet adherence for dyads
Time frame: Day 1
Dietary patterns of mothers
Time frame: Day 1
Physical activity for dyads
Time frame: Day 1
Sleep quality for dyads
Time frame: Day 1
Smoking habits for dyads
Time frame: Day 1
Alcohol consumption for dyads
Time frame: Day 1
Sedentary screen time for children
Time frame: Day 1
Socio-economic status for mothers
Time frame: Day 1
Family relationships for mothers
Time frame: Day 1
Personal social capital for mothers
Time frame: Day 1
Neighborhood food environment for mothers
Time frame: Day 1
Social environment for mothers
Time frame: Day 1
Social participation for mothers
Time frame: Day 1
Weight of dyads
Time frame: Day 1
Height of dyads
Time frame: Day 1
Waist circumference of dyads
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Derived from this study: PubMed 40230801Vincenti 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.
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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. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Child Obesity, run by Buzzi Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 2 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Vincenti, Dr (+39 3898292390, alessandra.vincenti@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of childhood overweight and obesity (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06179381, which also lists 1 linked publication.
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 2 Jan 2024.