ObesityFACILITYNCT06164340
FACILITY: Feeding the fAmiLy: the Intergenerational approaCh to fIght obesiTY
An observational study of Obesity and Obesity, Childhood, 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, Obesity, Childhood, Obesity, Maternal
- 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: The retrospective study population will be a subgroup of the population previously enrolled during the cross-sectional study according to the previously identified eligibility criteria, specifically: mother-child dyads with overweight or obesity and early adiposity rebound (case) and mother-child dyads with healthy weight (control) will be enrolled. The control group will be matched to the cases selected on the basis of various factors (e.g., age, sex, race) to ensure to reduce confounding factors. New subjects will be enrolled according to the eligibility criteria of the retrospective study if the simple size is not reached.
Who may be able to join
- 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;
Show all 19Show fewer
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Retrospective Investigation of Lifestyle and Socio-cultural-economic Determinants Driving to Early Adiposity Rebound (FACILITY)
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 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 years old). The estimated duration is 24 months.
The primary objective of the FACILITY retrospective case-control phase is to identify maternal and child lifestyle and health determinants of EAR associated with childhood obesity. The secondary objective is to identify culture-accepted early-tailored-efficiency "model to action" aligned with the Maternal, New-born, and Child Health (MNCH) continuum care approach. This "policy-model" will be based on the results of the retrospective study and on the analysis of the current scientific evidence and on the research of the global, national and local policies (city of Milan).
Participants of this study are mother-child dyads previously enrolled in the FACILITY cross-sectional study and willing to participate in the retrospective phase or newly enrolled patients from the hospital according to the eligible criteria. If eligible, variables related to the mothers and to the children will be retrospectively investigated with structured interviews and/or by consulting medical records.
For the mothers, anthropometric variables (height and weight during and after pregnancy) will be obtained from medical records, if available, or will be requested orally by structured interviews. In addition, pathological anamnesis and drug consumption during pregnancy will be evaluated with the same methodologies. Information related to pregnancy, supplements consumption during pregnancy, as well as dietary, smoking, and alcohol habits during pregnancy and breastfeeding will be assessed with structured interviews.
For the child, the nutritional status during the first 1000 days will be evaluated with the pediatric health booklet (weight, height/length, and head circumference). The type of breastfeeding and weaning characteristics will be investigated through a structured interview with the mothers. The child's dietary habits, physical activity, and motor gross achievement will be explored with the same methodologies.
- Conditions
- Obesity, Obesity, Childhood, Obesity, Maternal, Overweight
- Keywords
- Overweight, Obesity, Childhood obesity, Continuum of Care, Maternal health, Child Health, Policy, Food policies, Adiposity Rebound
- Medical subject headings
- Obesity, Pediatric Obesity, Pregnancy in Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group - Mother-child dyads | Case group: mother-child dyads (including children with overweight or obesity and early adiposity rebound). | |
| Control group - Mother-child dyads | Control group: mother-child dyads (including children with healthy weight). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early adiposity rebound (EAR)
Child health booklet: early adiposity rebound (years) if minimum BMI occurred before 5 years of age.
Measured: Day 1
Overweight and obesity
BMI percentile in the Center for Disease Control (CDC) growth charts (overweight: 85th-95th percentile/2-3 Z score; obesity ≥ 95th percentile/≥ 3 Z score).
Measured: Day 1
Breastfeeding mode
Structured interview (exclusive breastfeeding, formula feeding, mixed mode).
Measured: Day 1
Mode and characteristics of weaning
Structured interview (time of initiation, foods' introduction sequence and proposed portions, introduction or non-introduction of all food categories, difficulties experienced by the mother or the child, safety measures, proper feeding in accordance with appetite and satiety signals, typical food traditions of the maternal culture/ethnicity).
Measured: Day 1
Eating habits between 1 and 2 years of age
Structured interview (food and beverages consumed at breakfast, lunch, dinner and snacks, meal skipping, dietary variety).
Measured: Day 1
Physical activity during the first 2 years
Structured interview (minutes and/or hours of daily physical activity). Results will be compared with WHO guidelines.
Measured: Day 1
Gross Motor Milestone Development
Structured interview (month when child started to walk). If age starting walking will be >18 months of age the child will be categorized as "late Motor Milestone".
Measured: Day 1
Socio-demographic status for children
Structured interview: child age (year), race/ethnicity (Caucasian, Black, Medioriental, Asiatic, Hispanic), education level (none, elementary, middle school, high school, degree), number of people in the house, number of years in Italy.
Measured: Day 1
Gestational weight gain
Difference between pre- and post-pregnancy weight (kg). The gestational weight gain will be compared with IOM Pregnancy Weight Guidelines.
Measured: Day 1
Pregnancy characteristic
Structured interview: spontaneous or assisted pregnancy, pregnancy related-diseases, delivery mode (natural or caesarean), birth spacing (year).
Measured: Day 1
Dietary pattern during pregnancy
Structured interview (adherence to particular nutritional advice, the person/expert who gave the nutritional information, dietary pattern followed, consumption of typical traditional food/dishes).
Measured: Day 1
Supplements consumed during pregnancy
Structured interview (number and type of supplement consumed, period of assumption, who advised her to take the supplement).
Measured: Day 1
Food knowledge
Structured interview (choose between food options to identify foods containing carbohydrates/dietary fiber, foods low in fats, foods richest in protein/calories, individual perception on the definition of a balanced diet and healthy eating, perception of a relationship between dietary pattern and health status).
Measured: Day 1
Smoking habits during and after pregnancy
Structured interview. Smoking of traditional tobacco cigarettes (manufactured or hand-rolled cigarettes) or electronic cigarettes or heated tobacco product (HTP) products before, during, after pregnancy. Based on smoking declaration women will be categorized as follows: 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 during pregnancy
Structured interview. Weekly consumption of alcohol units during and after pregnancy [1 alcohol unit = 12 g = small glass of red/white/rosé wine = can of double malt beer = small shot of hard liquor]; alcohol consumption history. Based on alcohol consumption declaration, women will be categorized as follows: 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
Socio-demographic characteristics status for mothers
Structured interview. Mothers' age, marital status, race/ethnicity, nationality, education level, residence, number of people in the house, current job, number of children, number of years in Italy, household status, household income.
Measured: Day 1
Secondary outcomes (1)
Development of a "Model to action" policy to tackle childhood obesity
"policy-model" based on the results of the retrospective study
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 posted11 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.
- 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
- Case-control
- Time perspective
- Retrospective
- 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
- 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, ItalyValeria Calcaterra, Principal investigator, Pediatric Department, Buzzi Children's Hospital, 20154 Milano, Italy. Department of Internal Medicine and Therapeutics, University of Pavia, 27100 Pavia, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164340
- Sponsor's protocol ID
- 03102023
- Other IDs
- CUP: F13C22001210007
- Acronym
- FACILITY
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Investigation of Lifestyle and Socio-cultural-economic Determinants Driving to Early Adiposity Rebound (FACILITY)
- ClinicalTrials.gov ID
- NCT06164340
- Acronym / sponsor ID
- FACILITY / 03102023
- Conditions
- Obesity, Obesity, Childhood, Obesity, Maternal, Overweight
- Keywords
- Overweight, Obesity, Childhood obesity, Continuum of Care, Maternal health, Child Health, Policy, Food policies
- 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
- 11 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 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 years old). The estimated duration is 24 months.
The primary objective of the FACILITY retrospective case-control phase is to identify maternal and child lifestyle and health determinants of EAR associated with childhood obesity. The secondary objective is to identify culture-accepted early-tailored-efficiency "model to action" aligned with the Maternal, New-born, and Child Health (MNCH) continuum care approach. This "policy-model" will be based on the results of the retrospective study and on the analysis of the current scientific evidence and on the research of the global, national and local policies (city of Milan).
Participants of this study are mother-child dyads previously enrolled in the FACILITY cross-sectional study and willing to participate in the retrospective phase or newly enrolled patients from the hospital according to the eligible criteria. If eligible, variables related to the mothers and to the children will be retrospectively investigated with structured interviews and/or by consulting medical records.
For the mothers, anthropometric variables (height and weight during and after pregnancy) will be obtained from medical records, if available, or will be requested orally by structured interviews. In addition, pathological anamnesis and drug consumption during pregnancy will be evaluated with the same methodologies. Information related to pregnancy, supplements consumption during pregnancy, as well as dietary, smoking, and alcohol habits during pregnancy and breastfeeding will be assessed with structured interviews.
For the child, the nutritional status during the first 1000 days will be evaluated with the pediatric health booklet (weight, height/length, and head circumference). The type of breastfeeding and weaning characteristics will be investigated through a structured interview with the mothers. The child's dietary habits, physical activity, and motor gross achievement will be explored with the same methodologies.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group - Mother-child dyads | – | –Case group: mother-child dyads (including children with overweight or obesity and early adiposity rebound). |
| Control group - Mother-child dyads | – | –Control group: mother-child dyads (including children with healthy weight). |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The retrospective study population will be a subgroup of the population previously enrolled during the cross-sectional study according to the previously identified eligibility criteria, specifically: mother-child dyads with overweight or obesity and early adiposity rebound (case) and mother-child dyads with healthy weight (control) will be enrolled. The control group will be matched to the cases selected on the basis of various factors (e.g., age, sex, race) to ensure to reduce confounding factors. New subjects will be enrolled according to the eligibility criteria of the retrospective study if the simple size is not reached.
Key inclusion criteria (19 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;
- Early adiposity rebound (< 5 years of age);
Key exclusion criteria (8 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
Early adiposity rebound (EAR)
Time frame: Day 1
Child health booklet: early adiposity rebound (years) if minimum BMI occurred before 5 years of age.
Overweight and obesity
Time frame: Day 1
BMI percentile in the Center for Disease Control (CDC) growth charts (overweight: 85th-95th percentile/2-3 Z score; obesity ≥ 95th percentile/≥ 3 Z score).
Breastfeeding mode
Time frame: Day 1
Structured interview (exclusive breastfeeding, formula feeding, mixed mode).
Mode and characteristics of weaning
Time frame: Day 1
Structured interview (time of initiation, foods' introduction sequence and proposed portions, introduction or non-introduction of all food categories, difficulties experienced by the mother or the child, safety measures, proper feeding in accordance with appetite and satiety signals, typical food traditions of the maternal culture/ethnicity).
Eating habits between 1 and 2 years of age
Time frame: Day 1
Structured interview (food and beverages consumed at breakfast, lunch, dinner and snacks, meal skipping, dietary variety).
Physical activity during the first 2 years
Time frame: Day 1
Structured interview (minutes and/or hours of daily physical activity). Results will be compared with WHO guidelines.
Gross Motor Milestone Development
Time frame: Day 1
Structured interview (month when child started to walk). If age starting walking will be >18 months of age the child will be categorized as "late Motor Milestone".
Socio-demographic status for children
Time frame: Day 1
Structured interview: child age (year), race/ethnicity (Caucasian, Black, Medioriental, Asiatic, Hispanic), education level (none, elementary, middle school, high school, degree), number of people in the house, number of years in Italy.
Gestational weight gain
Time frame: Day 1
Difference between pre- and post-pregnancy weight (kg). The gestational weight gain will be compared with IOM Pregnancy Weight Guidelines.
Pregnancy characteristic
Time frame: Day 1
Structured interview: spontaneous or assisted pregnancy, pregnancy related-diseases, delivery mode (natural or caesarean), birth spacing (year).
Dietary pattern during pregnancy
Time frame: Day 1
Structured interview (adherence to particular nutritional advice, the person/expert who gave the nutritional information, dietary pattern followed, consumption of typical traditional food/dishes).
Supplements consumed during pregnancy
Time frame: Day 1
Structured interview (number and type of supplement consumed, period of assumption, who advised her to take the supplement).
Food knowledge
Time frame: Day 1
Structured interview (choose between food options to identify foods containing carbohydrates/dietary fiber, foods low in fats, foods richest in protein/calories, individual perception on the definition of a balanced diet and healthy eating, perception of a relationship between dietary pattern and health status).
Smoking habits during and after pregnancy
Time frame: Day 1
Structured interview. Smoking of traditional tobacco cigarettes (manufactured or hand-rolled cigarettes) or electronic cigarettes or heated tobacco product (HTP) products before, during, after pregnancy. Based on smoking declaration women will be categorized as follows: 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).
Alcohol consumption during pregnancy
Time frame: Day 1
Structured interview. Weekly consumption of alcohol units during and after pregnancy [1 alcohol unit = 12 g = small glass of red/white/rosé wine = can of double malt beer = small shot of hard liquor]; alcohol consumption history. Based on alcohol consumption declaration, women will be categorized as follows: 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).
Socio-demographic characteristics status for mothers
Time frame: Day 1
Structured interview. Mothers' age, marital status, race/ethnicity, nationality, education level, residence, number of people in the house, current job, number of children, number of years in Italy, household status, household income.
1 secondary outcome
Development of a "Model to action" policy to tackle childhood obesity
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 18 Dec 2023.
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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.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity, Childhood, 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 19 inclusion and 8 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 18 Dec 2023. 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?
Early adiposity rebound (EAR) (time frame: Day 1). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2023.