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Joint School-Health Project of the Neapolitan Child

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05901220
Recruitment Status : Completed
First Posted : June 13, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, MD, PhD, Federico II University

Study Description
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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.


Condition or disease Intervention/treatment Phase
No Condition Behavioral: Healthy lifestyle Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Joint School-Health Project of the Neapolitan Child
Actual Study Start Date : September 1, 2022
Actual Primary Completion Date : June 30, 2023
Actual Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arms and Interventions
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Arm Intervention/treatment
Experimental: Students of a school in the Campania region Behavioral: Healthy lifestyle
An educational programme to promote healthy lifestyle will be performed.


Outcome Measures
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Primary Outcome Measures :
  1. Intake of energy and nutrients [ Time Frame: 7-day ]
    A 7-day food diary to evaluate the dietary intake of energy and nutrients.

  2. Intake of ultraprocessed foods [ Time Frame: 7-day ]
    A 7-day food diary to evaluate the dietary intake of ultraprocessed foods.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05901220


Locations
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Italy
Department of Traslational Medical Science - University of Naples Federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
More Information
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Responsible Party: Roberto Berni Canani, MD, PhD, Professor, Federico II University
ClinicalTrials.gov Identifier: NCT05901220    
Other Study ID Numbers: Federico II-Cardarelli
First Posted: June 13, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No