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

NCT06164340 | Unknown

• 2 other identifiers: 03102023CUP: 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; Obesity, Childhood; Obesity, Maternal; Overweight

Keywords

Overweight; Obesity; Childhood obesity; Continuum of Care; Maternal health; Child Health; Policy; Food policies; Adiposity Rebound

Outcome Measures

Primary Outcomes (16)

• Early adiposity rebound (EAR)

  Child health booklet: early adiposity rebound (years) if minimum BMI occurred before 5 years of age.

  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).

  Day 1

• Breastfeeding mode

  Structured interview (exclusive breastfeeding, formula feeding, mixed mode).

  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).

  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).

  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.

  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".

  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.

  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.

  Day 1

• Pregnancy characteristic

  Structured interview: spontaneous or assisted pregnancy, pregnancy related-diseases, delivery mode (natural or caesarean), birth spacing (year).

  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).

  Day 1

• Supplements consumed during pregnancy

  Structured interview (number and type of supplement consumed, period of assumption, who advised her to take the supplement).

  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).

  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).

  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).

  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.

  Day 1

Secondary Outcomes (1)

• Development of a "Model to action" policy to tackle childhood obesity

  Day 1

Study Arms (2)

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).

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

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.

You may qualify if:

• 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);
• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

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

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

• Hellas Cena

  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

• Valeria Calcaterra

  Pediatric Department, Buzzi Children's Hospital, 20154 Milano, Italy. Department of Internal Medicine and Therapeutics, University of Pavia, 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: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 11, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 18, 2023

Record last verified: 2023-12