Joint School-Health Project of the Neapolitan Child

NCT05901220 | Completed

• 1 other identifier: Federico II-Cardarelli
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

No Condition

Outcome Measures

Primary Outcomes (7)

• Intake of energy and nutrients

  A 7-day food diary to evaluate the dietary intake of energy and nutrients.

  7-day

• Intake of ultraprocessed foods

  A 7-day food diary to evaluate the dietary intake of ultraprocessed foods.

  7-day

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Students of a school in the Campania region

EXPERIMENTAL

Behavioral: Healthy lifestyle

Interventions

Healthy lifestyle BEHAVIORAL

An educational programme to promote healthy lifestyle will be performed.

Students of a school in the Campania region

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• students aged 5-13 years of both sex;
• parents/tutor written informed consent.

You may not qualify if:

• lack of written informed consent;
• unwillingness to participate.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: June 13, 2023
• Study Start: September 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)