CClinicalTrials.gg
Not yet recruitingNCT05784376ICAROUpdated Mar 29, 2023

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

An observational study in Diet Habit, Diet, Healthy and Child Obesity, sponsored by Neuromed IRCCS. Not yet recruiting. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by Neuromed IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
2 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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03

In context

Pediatric Obesity

1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 200 across 231 observational studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

Neuromed IRCCS is the lead sponsor of 76 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Interventions

  • BehavioralEducation-based

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

06

What researchers measure

Primary outcomes

  1. Consumption of UPF in both parents and kids (changes in)

    3-day food records

    Time frame: 6 months

  2. Nutrition knowledge levels of parents (changes in)

    Questionnaire to evaluate nutrition knowledge of parents

    Time frame: 6 months

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

    self-reported height and weight

    Time frame: 6 months

Secondary outcomes

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

    Mediterranean Diet Screener and data from 3-day food records

    Time frame: 6 months

  2. Parental feeding practices (changes in)

    Questionnaire to evaluate parental feeding practices

    Time frame: 6 months

  3. Psychological distress in parents (changes in)

    12-Item General Health Questionnaire (GHQ-12)

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05784376
Lead sponsor
Neuromed IRCCS
Collaborators
Universita degli Studi di Catania
Responsible party
Marialaura Bonaccio (Principal Investigator, Neuromed IRCCS) — Principal investigator
First posted
Mar 24, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Jun 30, 2024 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Mar 29, 2023

Study contacts

Marialaura Bonaccio, PhD
Contact
marialaura.bonaccio@moli-sani.org
3394995848
Marialaura Bonaccio, PhD
principal investigator · IRCCS Istituto Neurologico Mediterraneo Neuromed
Licia Iacoviello, MD, PhD
principal investigator · IRCCS Istituto Neurologico Mediterraneo Neuromed

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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