Joint School-Health Project of the Neapolitan Child

Not Applicable

Completed

• Conditions: No Condition
• Interventions: Behavioral: Healthy lifestyle

• Registration Number: NCT05901220
• Lead Sponsor: Federico II University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2023-05-06
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-13
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Students of a school in the Campania region	Healthy lifestyle	-

Primary Outcome Measures

Name	Time	Method
Intake of ultraprocessed foods	7-day	A 7-day food diary to evaluate the dietary intake of ultraprocessed foods.
The sleep habits	9 months	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.
Intake of energy and nutrients	7-day	A 7-day food diary to evaluate the dietary intake of energy and nutrients.
Intake of dietary advanced glycation end-products	7-day	A 7-day food diary to evaluate the dietary intake of the detrimental compounds of ultraprocessed foods, the advanced glycation end-products.
Adherence to the Mediterranean Diet	9 months	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
The hours spent in sedentary behaviors	9 months	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.
The hours of physical activity	9 months	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.

Trial Locations

Locations (1)

Department of Traslational Medical Science - University of Naples Federico II; 🇮🇹 Naples, Italy