No ConditionNCT05901220
Joint School-Health Project of the Neapolitan Child
A study testing Healthy lifestyle in people with No Condition, run by Federico II University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- No Condition
- What is being tested?
- Healthy lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- students aged 5-13 years of both sex;
- parents/tutor written informed consent.
Who cannot join
- lack of written informed consent;
- unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Traslational Medical Science - University of Naples Federico II
Naples, 80131
About this study
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
- Being tested
- Healthy lifestyle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy lifestyleBehavioural
An educational programme to promote healthy lifestyle will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Students of a school in the Campania region | Experimental | Not described Receives: Behavioral: Healthy lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intake of energy and nutrients
A 7-day food diary to evaluate the dietary intake of energy and nutrients.
Measured: 7-day
Intake of ultraprocessed foods
A 7-day food diary to evaluate the dietary intake of ultraprocessed foods.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Sep 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No ConditionStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901220
- Sponsor's protocol ID
- Federico II-Cardarelli
- Status last verified
- Sep 2023
- First submitted
- 6 May 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint School-Health Project of the Neapolitan Child
- ClinicalTrials.gov ID
- NCT05901220
- Acronym / sponsor ID
- Federico II-Cardarelli
- Conditions
- No Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Students of a school in the Campania region | Experimental | Behavioral: Healthy lifestyle |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- students aged 5-13 years of both sex;
- parents/tutor written informed consent.
Key exclusion criteria (2 listed)
- lack of written informed consent;
- unwillingness to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy lifestyleAn educational programme to promote healthy lifestyle will be performed. | Behavioural | Students of a school in the Campania region |
Primary outcome
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.
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 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for No Condition
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy lifestyle in people with No Condition, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intake of energy and nutrients (time frame: 7-day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.