Clinical trial NCT06179381: Feeding the fAmiLy: the Intergenerational approaCh to fIght obesiTY (FACILITY)
Official title: FACILITY (Feeding the fAmiLy: the Intergenerational approaCh to fIght obesiTY)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity
Child Obesity
Maternal Obesity
Overweight
Keywords: Overweight
Obesity
Childhood obesity
Continuum of Care
Maternal health
Child Health
Adiposity rebound
Lead sponsor: Buzzi Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Pavia
First posted: 2023-12-21
Enrollment: 269
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
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.

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 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.

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.

Primary outcomes:
measure: Prevalence of childhood overweight and obesity
timeFrame: Day 1
Secondary outcomes:
measure: Mediterranean diet adherence for dyads
timeFrame: Day 1
measure: Dietary patterns of mothers
timeFrame: Day 1
measure: Physical activity for dyads
timeFrame: Day 1
measure: Sleep quality for dyads
timeFrame: Day 1
measure: Smoking habits for dyads
timeFrame: Day 1
measure: Alcohol consumption for dyads
timeFrame: Day 1
measure: Sedentary screen time for children
timeFrame: Day 1
measure: Socio-economic status for mothers
timeFrame: Day 1
measure: Family relationships for mothers
timeFrame: Day 1
measure: Personal social capital for mothers
timeFrame: Day 1
measure: Neighborhood food environment for mothers
timeFrame: Day 1
measure: Social environment for mothers
timeFrame: Day 1
measure: Social participation for mothers
timeFrame: Day 1
measure: Weight of dyads
timeFrame: Day 1
measure: Height of dyads
timeFrame: Day 1
measure: Waist circumference of dyads
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, 27100 Pavia, Italy. Pediatric Department, Buzzi Children's Hospital, 20154 Milano, Italy
name: Valeria Calcaterra, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Hellas Cena, Dr
role: PRINCIPAL_INVESTIGATOR
References: