MuLtidimensional School-based and Family interVentions to Promote hEalthy and Sustainable LifestYle for the Childhood

NCT ID: NCT05966051

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-18

Study Completion Date

2025-06-01

Brief Summary

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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

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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

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Childhood Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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,

Educational interventions

Intervention Type BEHAVIORAL

The educational interventions will consist in:

Interventions

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Educational interventions

The educational interventions will consist in:

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role collaborator

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlotta Franchi, PhD

Role: PRINCIPAL_INVESTIGATOR

Mario Negri Institute for Pharmacological Research

Marta Baviera, PharmDr

Role: PRINCIPAL_INVESTIGATOR

Mario Negri Institute for Pharmacological Research

Maria Vittoria Conti, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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Istituto Comprensivo Luigi Cadorna

Milan, MI, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 39475855 (View on PubMed)

Other Identifiers

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F13C22001210007

Identifier Type: OTHER

Identifier Source: secondary_id

IRFMN-8979

Identifier Type: -

Identifier Source: org_study_id

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