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Clinical Trials/NCT05901220
NCT05901220
Completed
Not Applicable

Joint School-Health Project of the Neapolitan Child

Federico II University1 site in 1 country223 target enrollmentSeptember 1, 2022
ConditionsNo Condition

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
No Condition
Sponsor
Federico II University
Enrollment
223
Locations
1
Primary Endpoint
Intake of energy and nutrients
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Federico II University
Responsible Party
Principal Investigator
Principal Investigator

Roberto Berni Canani, MD, PhD

Professor

Federico II University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Intake of energy and nutrients

Time Frame: 7-day

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

Intake of ultraprocessed foods

Time Frame: 7-day

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

The sleep habits

Time Frame: 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 dietary advanced glycation end-products

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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