Clinical trial NCT05966051: MuLtidimensional School-based and Family interVentions to Promote hEalthy and Sustainable LifestYle for the Childhood
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Childhood Obesity
Keywords: Childhood Obesity Prevention
Childhood Obesity determinants
Educational Interventions
Primary schools
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
Collaborators: name: University of Pavia
First posted: 2023-07-28
Enrollment: 226
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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:

Eligibility criteria: Inclusion Criteria:

* children 6-11 years
* children whose parents will provide written consent to participate.

Exclusion Criteria:

* Children who do not have inclusion criteria.

Primary outcomes:
measure: Investigate prevalence of childhood overweight and/or obesity
timeFrame: Baseline
measure: Investigation on adherence to Mediterranian diet
timeFrame: Baseline
measure: Assessment of the consumption of ultra-processed food by children
timeFrame: Baseline
measure: Investigation of family lifestyles
timeFrame: Baseline
Secondary outcomes:
measure: Feasibility of multidimensional school-based educational interventions
timeFrame: 6 months
measure: Investigation of changes in adherence to Mediterranian diet
timeFrame: Baseline, 6 and 12 months
measure: Assessment of changes of the consumption of ultra-processed food by children
timeFrame: Baseline, 6 and 12 months
measure: Investigation of changes of family lifestyles
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Comprensivo Luigi Cadorna
state: MI
Study officials:
affiliation: Mario Negri Institute for Pharmacological Research
name: Carlotta Franchi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mario Negri Institute for Pharmacological Research
name: Marta Baviera, PharmDr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pavia
name: Maria Vittoria Conti, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.