Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05901220
Other study ID # Federico II-Cardarelli
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02265224 - Bioequivalence Study of Two Different Formulations of N-acetyl-cysteine (NAC) Phase 1
Completed NCT00379210 - Neural Effects of Mindfulness Training on Attention N/A
Active, not recruiting NCT04455295 - Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation N/A
Not yet recruiting NCT03225638 - Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®) N/A
Completed NCT04854642 - A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers Phase 1
Terminated NCT04803396 - Ascending Dose Tolerability Trial and PK Assessment in Healthy Volunteers After Single & Multiple Oral Intake of DF2755A Phase 1
Recruiting NCT03134482 - Comparison of Clinical Outcomes Between IVM and Minimal Stimulation IVF in Patients With PCOS N/A
Completed NCT05882942 - Matcha Green Tea Effects at Rest and During Moderate-intensity Exercise in Females N/A
Completed NCT03044301 - Performance Thresholds Evaluation by Wet Injection Quantification and Magnetic Resonance Imaging (MRI) of Subcutaneous and Intramuscular Injections (0,65ml) of Several Configurations of Needle-free Devices (ZENEO®) N/A
Completed NCT01563224 - GABA-B Receptor Function in Healthy Volunteers N/A
Terminated NCT04227405 - TOGETHER: A Couple's Model to Enhance Relationships and Economic Stability N/A
Completed NCT04802967 - A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males Phase 1