Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179381
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-11-23
Brief Title:
Feeding the fAmiLy the Intergenerational approaCh to fIght obesiTY FACILITY
Sponsor:
Buzzi Childrens Hospital
Organization:
Buzzi Childrens Hospital
Study Overview
Official Title:
FACILITY Feeding the fAmiLy the Intergenerational approaCh to fIght obesiTY
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FACILITY
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
Detailed Description:
The FACILITY cross-sectional study is conducted in the Buzzi Childrens 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 childrenadolescents 2 Impact of socio-economic-cultural factors on overweight and obesity in childrenadolescents
To mother-child dyads coming to the outpatient facilities of the Department of Pediatrics Buzzi Childrens 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 childrenadolescents - 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 ie 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
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 childrenadolescents 2 Impact of socio-economic-cultural factors on overweight and obesity in childrenadolescents
To mother-child dyads coming to the outpatient facilities of the Department of Pediatrics Buzzi Childrens 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 childrenadolescents - 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CUP F13C22001210007 | OTHER_GRANT | PNRR - MUR | None |