The Southern Italian Children, Adolescents and PaRents COhort Study on Nutrition and Health

NCT05784376 | Unknown

• 1 other identifier: DEP_012023
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Childhood obesity is a major public health concern worldwide and parents play a powerful role in children's eating behaviour. Most prior studies analysed parents and children's diet almost exclusively by evaluating food composition (i.e. calorie, macro- and micronutrient contents), with no or little attention paid to degree of food processing. The NOVA classification was proposed as a novel way to look at foods based on the degree of processing of foods rather than on their nutritional composition, postulating that processing may be as relevant to health as food composition. The term ultra-processed food (UPF) indicates industrially manufactured ready-to-eat or ready-to-heat formulations made mostly or entirely from substances extracted from foods or derived from food constituents often containing added flavours, colours, emulsifiers and other cosmetic additives. Most importantly, these industrial formulations are designed to maximize palatability and consumption through a combination of calorie-dense ingredients and chemical additives. Robust and well-conducted cohort studies worldwide found that a large dietary share of UPF is associated with shorter survival and an increased risk of non-communicable diseases. Given the rising popularity of UPF globally, and also in Mediterranean countries, the issue of food processing should be prioritized in relevant dietary recommendations with emphasis on consumption of minimally/unprocessed foods.

Conditions

Diet Habit; Diet, Healthy; Child Obesity; Parents; Nutrition, Healthy

Outcome Measures

Primary Outcomes (3)

• Consumption of UPF in both parents and kids (changes in)

  3-day food records

  6 months

• Nutrition knowledge levels of parents (changes in)

  Questionnaire to evaluate nutrition knowledge of parents

  6 months

• Body weight of both parent and kids (>14 years) (changes in)

  self-reported height and weight

  6 months

Secondary Outcomes (3)

• Adherence to the Mediterranean Diet in both parents and kids (changes in)

  6 months

• Parental feeding practices (changes in)

  6 months

• Psychological distress in parents (changes in)

  6 months

Interventions

Education-based BEHAVIORAL

Nutrition education delivered via text messages through mobile applications (e.g. WhatsApp).

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The Southern Italian Children, Adolescents and PaRents COhort Study on Nutrition and Health (ICARO Study) is designed as a web-based prospective cohort of children, adolescents and their parents/caregivers residing in Southern Italy. Participants' data will be collected through on-line questionnaires available on the Study's website, and updated every 6 months (i.e. dietary intake, anthropometric data and health status) or yearly (i.e. socio-demographics, lifestyle, and other environmental factors). Participants will be recruited through multimedia campaigns (regional newspapers, internet, social networks), contacts with schools also through the regional school system, professional channels (e.g. paediatricians, general practitioners), and targeted meetings with the general population.

You may qualify if:

• parents/caregivers of 2-13 years old children, and adolescents aged 14-18 years at recruitment residing in Southern Italy.

You may not qualify if:

• not being fluent in Italian language;
• refusal to sign informed consent;
• lack of an electronic device with internet access (i.e. computer, mobile phone).

Sponsors & Collaborators

• Neuromed IRCCS: lead
• Universita degli Studi di Catania: collaborator

MeSH Terms

Conditions

Feeding Behavior; Pediatric Obesity

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marialaura Bonaccio, PhD

  IRCCS Istituto Neurologico Mediterraneo Neuromed

  PRINCIPAL INVESTIGATOR

• Licia Iacoviello, MD, PhD

  IRCCS Istituto Neurologico Mediterraneo Neuromed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marialaura Bonaccio, PhD

CONTACT

3394995848; marialaura.bonaccio@moli-sani.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: March 29, 2023

Record last verified: 2023-03