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NCT Number: NCT05966051

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

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.

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Key information

Conditions

Childhood Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Comprensivo Luigi Cadorna

Milan, MI, 20148, Italy

About this study

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:

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children who do not have inclusion criteria.

Treatment and study plan

Educational interventions

Behavioral

The educational interventions will consist in:

Primary outcomes

  1. Investigate prevalence of childhood overweight and/or obesity

    Time frame: Baseline

    Weight and height will be combined to report BMI in kg/m^2

  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.

  3. 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)

  4. 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.

Secondary outcomes

  1. Feasibility of multidimensional school-based educational interventions

    Time frame: 6 months

    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

  2. Investigation of changes in adherence to Mediterranian diet

    Time frame: Baseline, 6 and 12 months

    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.

  3. Assessment of changes of the consumption of ultra-processed food by children

    Time frame: Baseline, 6 and 12 months

    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)

  4. Investigation of changes of family lifestyles

    Time frame: Baseline, 6 and 12 months

    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.

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Collaborators

  • University of Pavia

Registry information

Official study title

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

Acronym: LIVELY

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 28, 2023
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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