Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05784376 |
| Other study ID # |
DEP_012023 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
March 2023 |
| Source |
Neuromed IRCCS |
| Contact |
Marialaura Bonaccio, PhD |
| Phone |
3394995848 |
| Email |
marialaura.bonaccio[@]moli-sani.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
