Joint School-Health Project of the Neapolitan Child

No Condition Clinical Trial

Official title:

Joint School-Health Project of the Neapolitan Child

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901220
• Other study ID #: Federico II-Cardarelli
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Unhealthy lifestyle habits during the childhood could negatively impact the health status actual and during the later stages of life.

The School represents the major Institution to implement actions aim at promoting healthy lifestyles habits.

The Joint School-Health Project of the Neapolitan Child aimed at assessing the impact of a health education programme to improve lifestyle habits during the childood. To evalute the effects of this educational programme, the dietary habits, the sleep hours, the hours spent in sedentary behaviors (tv, smartphone) and the hours of physical activity will be evaluate at the baseline and at the end of the programme.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

Inclusion Criteria:

• students aged 5-13 years of both sex;

• parents/tutor written informed consent.

Exclusion Criteria:

• lack of written informed consent;

• unwillingness to participate.

Related Conditions & MeSH terms

• No Condition

Intervention

Behavioral:
• Healthy lifestyle
An educational programme to promote healthy lifestyle will be performed.

Locations

Country	Name	City	State
Italy	Department of Traslational Medical Science - University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intake of energy and nutrients	A 7-day food diary to evaluate the dietary intake of energy and nutrients.	7-day
Primary	Intake of ultraprocessed foods	A 7-day food diary to evaluate the dietary intake of ultraprocessed foods.	7-day
Primary	Intake of dietary advanced glycation end-products	A 7-day food diary to evaluate the dietary intake of the detrimental compounds of ultraprocessed foods, the advanced glycation end-products.	7-day
Primary	Adherence to the Mediterranean Diet	The KIDMED questionnaire is used to evaluate the adherence to the Mediterranean Diet. The total score is 12 points and a score of =3 means 'very low', between 4-7 'moderate' and =8 refers to 'high' adherence to the Mediterranean Diet	9 months
Primary	The sleep habits	The Italian Children's Sleep Habits Questionnaire is used to evaluate the sleep habits. The total score is the sum of the 10 responses obtained on each item and the highest scores indicate the worst sleep habits.	9 months
Primary	The hours spent in sedentary behaviors	The WHO-Collaborative Health Behaviour in School-aged Children (HBSC) study questionnaire is used to evaluate the hours spent in sedentary behaviors (tv, smartphone, etc). Three items assess sedentary screen-based activities: 1) "About how many hours a day do you usually watch television (including DVDs and videos) in your free time?" 2) "About how many hours a day do you usually play games on a computer or games console (Playstation, Xbox, GameCube etc.) in your free time?" and 3) "About how many hours a day do you usually use a computer for chatting on-line, internet, emailing, homework etc. in your free time? All three items have nine possible responses: "none at all", about 30 min, 1 hour, 2 hour, up to =7 hour/day. Responses for weekdays are recoded into = versus > 2 hour/day.	9 months
Primary	The hours of physical activity	The WHO-Collaborative Health Behaviour in School-aged Children (HBSC) study questionnaire is used to evaluate the hours of physical activity. Moderate to vigorous physical activity (MVPA) is assessed by asking: "On how many days in the past week were you physically active for 60 minutes or more". Physical activity was defined as "any activity that increases your heart rate and makes you get out of breath some of the time" with examples of such activities. Response categories were: "0 days", "1", "2", etc up to "7 days", recoded as < or = 5 times/week17. Vigorous physical activity (VPA) is assessed by asking: "Outside school hours, how many hours a week do you usually exercise in your free time so much that you get out of breath or sweat?" Response categories are none, about 30 minutes, and 1, 2-3, 4-6, =7 hours; recoded into < or = 2 hour/week.	9 months