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

MuLtidimensional School-based and Family Involved interVentions, to Promote a hEalthy and Sustainable LifestYle for the Childhood Obesity Primary Prevention: the LIVELY Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05966051
Acronym
LIVELY
Enrollment
226
Registered
2023-07-28
Start date
2023-10-18
Completion date
2025-06-01
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

Keywords

Childhood Obesity Prevention, Childhood Obesity determinants, Educational Interventions, Primary schools

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:

Interventions

BEHAVIORALEducational interventions

The educational interventions will consist in:

Sponsors

University of Pavia
CollaboratorOTHER
Mario Negri Institute for Pharmacological Research
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years

Inclusion criteria

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

Exclusion criteria

* Children who do not have inclusion criteria.

Design outcomes

Primary

MeasureTime frameDescription
Investigation of family lifestylesBaselineChildren 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.
Investigate prevalence of childhood overweight and/or obesityBaselineWeight and height will be combined to report BMI in kg/m\^2
Investigation on adherence to Mediterranian dietBaselineMediterranean 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 childrenBaselineNOVA 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)

Secondary

MeasureTime frameDescription
Feasibility of multidimensional school-based educational interventions6 monthsPerception 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
Investigation of changes in adherence to Mediterranian dietBaseline, 6 and 12 monthsMediterranean 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 changes of the consumption of ultra-processed food by childrenBaseline, 6 and 12 monthsNOVA 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 changes of family lifestylesBaseline, 6 and 12 monthsChildren 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026