Childhood ObesityLIVELYNCT05966051
MuLtidimensional School-based and Family interVentions to Promote hEalthy and Sustainable LifestYle for the Childhood
An observational study of Childhood Obesity, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
Childhood obesity condition has increased 10 times in the last 40 years, representing one of the most important public health challenges of our century. The overweight and obesity in children are conditions associated with several determinants, mostly related to dietary habits, physical activity, and environmental… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Educational interventions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 226 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2023to 1 Jun 2025
- Phase
- Observational
- 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 6 to 11 years
- All sexes
- Child
Study population: The study population will involve children 6-11 years old, attending the primary school Istituto Luigi Cadorna in Milano (Lombardy Region -Northern Italy) and their families.
Who may be able to join
- children 6-11 years
- children whose parents will provide written consent to participate.
Who cannot join
- Children who do not have inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MuLtidimensional School-based and Family Involved interVentions, to Promote a hEalthy and Sustainable LifestYle for the Childhood Obesity Primary Prevention: the LIVELY Study
Childhood obesity condition has increased 10 times in the last 40 years, representing one of the most important public health challenges of our century.
The overweight and obesity in children are conditions associated with several determinants, mostly related to dietary habits, physical activity, and environmental behavior.
Read more
To counteract childhood obesity, several prevention programs have been promoted, however evidence concerning their efficacy was contrasting, especially among the younger population and in the long term.
Moreover, due to the wide variety of interventions administered it is not clear which specific strategy (or combinations of strategies) was the most effective.
The LIVELY study aims 1) to assess the prevalence and the factors associated to childhood overweight and obesity; 2) to develop multidimensional strategies for prevention of childhood obesity by involving families and recognizing the role of schools as an environment for raising awareness on healthy and sustainable dietary patterns and lifestyle.
Read the detailed description
LIVELY is a study with a one group pre-test - post-test design (without control). The study will be conducted in the primary schools of the Istituto Luigi Cadorna in Milano (Lombardy Region, Northern Italy). The study population will involve children (6-11 years) belonging to different socioeconomic status and ethnic groups, attending classes of the school whose teachers will accept to participate.
The educational interventions will consist in:
- Conditions
- Childhood Obesity
- Being tested
- Educational interventions
- Keywords
- Childhood Obesity Prevention, Childhood Obesity determinants, Educational Interventions, Primary schools
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionsBehavioural
The educational interventions will consist in:
| Study group | Role | What they receive |
|---|---|---|
| Children attending primary school | In this study will be included children 6-11 years and their families, whose parents will provide written consent to participate, Receives: Behavioral: Educational interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate prevalence of childhood overweight and/or obesity
Weight and height will be combined to report BMI in kg/m^2
Measured: Baseline
Investigation on adherence to Mediterranian diet
Mediterranean Diet Quality Index for children and adolescents (KIDMED) will be used. The index ranges from 0 to 12 and is based on 16 questions. The sums of the values from the test are classified into three levels: scores ≥8 are considered optimal, 4-7 as average Mediterranean Diet adherence, and ≤3 as very low diet quality.
Measured: Baseline
Assessment of the consumption of ultra-processed food by children
NOVA classification, which will classify ultra-processed foods in four groups according to their level of processing (Group 1: unprocessed foods - Group 4: ultra-processed foods)
Measured: Baseline
Investigation of family lifestyles
Children Feeding Questionnaire (CFQ) will be used. It measures parental feeding practices and attitudes. The CFQ contains originally 31 items and measures the following seven factors: Perceived Responsibility (three items), Parent Perceived Weight (four items), Perceived Child Weight (six items), Parents Concern about Child Weight (three items), Parents' feeding practices: Restriction (eight items), Pressure to Eat (four items), and Monitoring (three items). The responses to all items are coded on a 5-point Likert scale ranging from one to five.
Measured: Baseline
Secondary outcomes (4)
Feasibility of multidimensional school-based educational interventions
Perception of usefulness of the interventions: appreciation questionnaires to investigate the satisfaction of the implemented activities; organization of the interventions and usefulness of the educational interventions
Measured: 6 months
Investigation of changes in adherence to Mediterranian diet
Mediterranean Diet Quality Index for children and adolescents (KIDMED) will be used. The index ranges from 0 to 12 and is based on 16 questions. The sums of the values from the test are classified into three levels: scores ≥8 are considered optimal, 4-7 as average Mediterranean Diet adherence, and ≤3 as very low diet quality.
Measured: Baseline, 6 and 12 months
Assessment of changes of the consumption of ultra-processed food by children
NOVA classification, which will classify ultra-processed foods in four groups according to their level of processing (Group 1: unprocessed foods - Group 4: ultra-processed foods)
Measured: Baseline, 6 and 12 months
Investigation of changes of family lifestyles
Children Feeding Questionnaire (CFQ) will be used. It measures parental feeding practices and attitudes. The CFQ contains originally 31 items and measures the following seven factors: Perceived Responsibility (three items), Parent Perceived Weight (four items), Perceived Child Weight (six items), Parents Concern about Child Weight (three items), Parents' feeding practices: Restriction (eight items), Pressure to Eat (four items), and Monitoring (three items). The responses to all items are coded on a 5-point Likert scale ranging from one to five.
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start18 Oct 2023
- Primary completion31 Dec 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia
- Responsible party
- Sponsor
- Investigators
- Carlotta Franchi, PhD, Principal investigator, Mario Negri Institute for Pharmacological ResearchMarta Baviera, PharmDr, Principal investigator, Mario Negri Institute for Pharmacological ResearchMaria Vittoria Conti, MSc, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966051
- Sponsor's protocol ID
- IRFMN-8979
- Other IDs
- F13C22001210007
- Acronym
- LIVELY
- Status last verified
- Oct 2025
- First submitted
- 23 Mar 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Basilico S, Conti MV, Ardoino I, Breda C, Loperfido F, Klaic E, Spialtini L, Foresta A, Orsini F, Ojeda Fernandez ML, Conca Bonizzoni S, Modena E, Tootoonchi Hamedani Y, Villa F, Cena H, Baviera M, Franchi C. Multidimensional School-Based and Family-Involved Interventions to Promote a Healthy and Sustainable Lifestyle (LIVELY) for Childhood Obesity Prevention: Study Protocol. JMIR Res Protoc. 2024 Oct 30;13:e57509. doi: 10.2196/57509.
PubMed 39475855
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MuLtidimensional School-based and Family Involved interVentions, to Promote a hEalthy and Sustainable LifestYle for the Childhood Obesity Primary Prevention: the LIVELY Study
- ClinicalTrials.gov ID
- NCT05966051
- Acronym / sponsor ID
- LIVELY / IRFMN-8979
- Conditions
- Childhood Obesity
- Keywords
- Childhood Obesity Prevention, Childhood Obesity determinants, Educational Interventions, Primary schools
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- University of Pavia
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 28 Jul 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.
Childhood obesity condition has increased 10 times in the last 40 years, representing one of the most important public health challenges of our century.
The overweight and obesity in children are conditions associated with several determinants, mostly related to dietary habits, physical activity, and environmental behavior.
To counteract childhood obesity, several prevention programs have been promoted, however evidence concerning their efficacy was contrasting, especially among the younger population and in the long term.
Moreover, due to the wide variety of interventions administered it is not clear which specific strategy (or combinations of strategies) was the most effective.
The LIVELY study aims 1) to assess the prevalence and the factors associated to childhood overweight and obesity; 2) to develop multidimensional strategies for prevention of childhood obesity by involving families and recognizing the role of schools as an environment for raising awareness on healthy and sustainable dietary patterns and lifestyle.
Detailed description
LIVELY is a study with a one group pre-test - post-test design (without control). The study will be conducted in the primary schools of the Istituto Luigi Cadorna in Milano (Lombardy Region, Northern Italy). The study population will involve children (6-11 years) belonging to different socioeconomic status and ethnic groups, attending classes of the school whose teachers will accept to participate.
The educational interventions will consist in:
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children attending primary school | – | Behavioral: Educational interventionsIn this study will be included children 6-11 years and their families, whose parents will provide written consent to participate, |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Age groups
- Child
- Study population
- The study population will involve children 6-11 years old, attending the primary school Istituto Luigi Cadorna in Milano (Lombardy Region -Northern Italy) and their families.
Key inclusion criteria (2 listed)
- children 6-11 years
- children whose parents will provide written consent to participate.
Key exclusion criteria (1 listed)
- Children who do not have inclusion criteria.
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 |
|---|---|---|
| Educational interventionsThe educational interventions will consist in: | Behavioural | Children attending primary school |
Primary outcome
Investigate prevalence of childhood overweight and/or obesity
Time frame: Baseline
Weight and height will be combined to report BMI in kg/m^2
Investigation on adherence to Mediterranian diet
Time frame: Baseline
Mediterranean Diet Quality Index for children and adolescents (KIDMED) will be used. The index ranges from 0 to 12 and is based on 16 questions. The sums of the values from the test are classified into three levels: scores ≥8 are considered optimal, 4-7 as average Mediterranean Diet adherence, and ≤3 as very low diet quality.
Assessment of the consumption of ultra-processed food by children
Time frame: Baseline
NOVA classification, which will classify ultra-processed foods in four groups according to their level of processing (Group 1: unprocessed foods - Group 4: ultra-processed foods)
Investigation of family lifestyles
Time frame: Baseline
Children Feeding Questionnaire (CFQ) will be used. It measures parental feeding practices and attitudes. The CFQ contains originally 31 items and measures the following seven factors: Perceived Responsibility (three items), Parent Perceived Weight (four items), Perceived Child Weight (six items), Parents Concern about Child Weight (three items), Parents' feeding practices: Restriction (eight items), Pressure to Eat (four items), and Monitoring (three items). The responses to all items are coded on a 5-point Likert scale ranging from one to five.
4 secondary outcomes
Feasibility of multidimensional school-based educational interventions
Time frame: 6 months
Investigation of changes in adherence to Mediterranian diet
Time frame: Baseline, 6 and 12 months
Assessment of changes of the consumption of ultra-processed food by children
Time frame: Baseline, 6 and 12 months
Investigation of changes of family lifestyles
Time frame: Baseline, 6 and 12 months
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 2 Oct 2025.
- Background: PubMed 39475855Basilico S, Conti MV, Ardoino I, Breda C, Loperfido F, Klaic E, Spialtini L, Foresta A, Orsini F, Ojeda Fernandez ML, Conca Bonizzoni S, Modena E, Tootoonchi Hamedani Y, Villa F, Cena H, Baviera M, Franchi C. Multidimensional School-Based and Family-Involved Interventions to Promote a Healthy and Sustainable Lifestyle (LIVELY) for Childhood Obesity Prevention: Study Protocol. JMIR Res Protoc. 2024 Oct 30;13:e57509. doi: 10.2196/57509.
- Individual participant dataSharing planned: Undecided
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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.
Carlotta Franchi, PhD principal investigator
Mario Negri Institute for Pharmacological Research
Marta Baviera, PharmDr principal investigator
Mario Negri Institute for Pharmacological Research
Maria Vittoria Conti, MSc principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by Mario Negri Institute for Pharmacological Research 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 1 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 2 Oct 2025. 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?
Investigate prevalence of childhood overweight and/or obesity (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966051, which also lists 1 linked publication.
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 2 Oct 2025.