Diet HabitICARONCT05784376
The Southern Italian Children, Adolescents and PaRents COhort Study on Nutrition and Health
An observational study of Diet Habit and Diet, Healthy, run by Neuromed IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit, Diet, Healthy, Child Obesity
- What is being tested?
- Education-based
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- parents/caregivers of 2-13 years old children, and adolescents aged 14-18 years at recruitment residing in Southern Italy.
Who cannot join
- not being fluent in Italian language;
- refusal to sign informed consent;
- lack of an electronic device with internet access (i.e. computer, mobile phone).
Trial locations and contacts
No sites are listed yet.
About this study
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:
- 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);
- 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;
- 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.
- Conditions
- Diet Habit, Diet, Healthy, Child Obesity, Parents, Nutrition, Healthy
- Being tested
- Education-based
- Medical subject headings
- Feeding Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education-basedBehavioural
Nutrition education delivered via text messages through mobile applications (e.g. WhatsApp).
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of UPF in both parents and kids (changes in)
3-day food records
Measured: 6 months
Nutrition knowledge levels of parents (changes in)
Questionnaire to evaluate nutrition knowledge of parents
Measured: 6 months
Body weight of both parent and kids (>14 years) (changes in)
self-reported height and weight
Measured: 6 months
Secondary outcomes (3)
Adherence to the Mediterranean Diet in both parents and kids (changes in)
Mediterranean Diet Screener and data from 3-day food records
Measured: 6 months
Parental feeding practices (changes in)
Questionnaire to evaluate parental feeding practices
Measured: 6 months
Psychological distress in parents (changes in)
12-Item General Health Questionnaire (GHQ-12)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Catania
- Responsible party
- Principal investigator, Marialaura Bonaccio, Neuromed IRCCS
- Investigators
- Marialaura Bonaccio, PhD, Principal investigator, IRCCS Istituto Neurologico Mediterraneo NeuromedLicia Iacoviello, MD, PhD, Principal investigator, IRCCS Istituto Neurologico Mediterraneo Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784376
- Sponsor's protocol ID
- DEP_012023
- Acronym
- ICARO
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Southern Italian Children, Adolescents and PaRents COhort Study on Nutrition and Health
- ClinicalTrials.gov ID
- NCT05784376
- Acronym / sponsor ID
- ICARO / DEP_012023
- Conditions
- Diet Habit, Diet, Healthy, Child Obesity, Parents, Nutrition, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Collaborators
- University of Catania
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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);
- 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;
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- parents/caregivers of 2-13 years old children, and adolescents aged 14-18 years at recruitment residing in Southern Italy.
Key exclusion criteria (3 listed)
- not being fluent in Italian language;
- refusal to sign informed consent;
- lack of an electronic device with internet access (i.e. computer, mobile phone).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education-basedNutrition education delivered via text messages through mobile applications (e.g. WhatsApp). | Behavioural | – |
Primary outcome
Consumption of UPF in both parents and kids (changes in)
Time frame: 6 months
3-day food records
Nutrition knowledge levels of parents (changes in)
Time frame: 6 months
Questionnaire to evaluate nutrition knowledge of parents
Body weight of both parent and kids (>14 years) (changes in)
Time frame: 6 months
self-reported height and weight
3 secondary outcomes
Adherence to the Mediterranean Diet in both parents and kids (changes in)
Time frame: 6 months
Parental feeding practices (changes in)
Time frame: 6 months
Psychological distress in parents (changes in)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marialaura Bonaccio, PhD principal investigator
IRCCS Istituto Neurologico Mediterraneo Neuromed
Licia Iacoviello, MD, PhD principal investigator
IRCCS Istituto Neurologico Mediterraneo Neuromed
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Habit and Diet, Healthy, run by Neuromed IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marialaura Bonaccio, PhD (3394995848, marialaura.bonaccio@moli-sani.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of UPF in both parents and kids (changes in) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.