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

Sponsor
Neuromed IRCCS (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05784376
Collaborator
Universita degli Studi di Catania (Other)
1,500
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Education-based

Detailed Description

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.

The ICARO study consists of two parts, namely Study 1 (observational) and Study 2 (intervention Study).

The main objectives of the ICARO Study (Study 1) are to:
  1. Evaluate the diet of participants (i.e. children, adolescents and their parents/caregivers) in terms of food composition (i.e. calorie, macro- and micronutrient contents) and complemented by a timely and innovative approach based on the evaluation of food processing, in line with the notion that the nutrient balance of a food is only a small part of its overall health potential (10);

  2. Investigate major demographic, socioeconomic, behavioural, psychosocial, and other environmental factors as potential correlates of diet and diet-related habits of both children, adolescents and parents;

  3. Analyse parental influence (e.g. food attitudes and knowledge) on children and adolescents diet quality and eating habits.

Within the ICARO Study population, an Intervention Study (Study 2) is planned to increase awareness and promote adherence to a minimally-processed Mediterranean Diet and reduce the dietary share of UPFs at family level.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Southern Italian Children, Adolescents and PaRents COhort Study on Nutrition and Health
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Outcome Measures

Primary Outcome Measures

  1. Consumption of UPF in both parents and kids (changes in) [6 months]

    3-day food records

  2. Nutrition knowledge levels of parents (changes in) [6 months]

    Questionnaire to evaluate nutrition knowledge of parents

  3. Body weight of both parent and kids (>14 years) (changes in) [6 months]

    self-reported height and weight

Secondary Outcome Measures

  1. Adherence to the Mediterranean Diet in both parents and kids (changes in) [6 months]

    Mediterranean Diet Screener and data from 3-day food records

  2. Parental feeding practices (changes in) [6 months]

    Questionnaire to evaluate parental feeding practices

  3. Psychological distress in parents (changes in) [6 months]

    12-Item General Health Questionnaire (GHQ-12)

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • parents/caregivers of 2-13 years old children, and adolescents aged 14-18 years at recruitment residing in Southern Italy.
Exclusion Criteria:
  • not being fluent in Italian language;

  • refusal to sign informed consent;

  • lack of an electronic device with internet access (i.e. computer, mobile phone).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Neuromed IRCCS
  • Universita degli Studi di Catania

Investigators

  • Principal Investigator: Marialaura Bonaccio, PhD, IRCCS Istituto Neurologico Mediterraneo Neuromed
  • Principal Investigator: Licia Iacoviello, MD, PhD, IRCCS Istituto Neurologico Mediterraneo Neuromed

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marialaura Bonaccio, Principal Investigator, Neuromed IRCCS
ClinicalTrials.gov Identifier:
NCT05784376
Other Study ID Numbers:
  • DEP_012023
First Posted:
Mar 24, 2023
Last Update Posted:
Mar 29, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2023