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

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Educational interventions

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 Type: Observational
• Enrollment (Actual): 226

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20148
      • Istituto Comprensivo Luigi Cadorna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Children who do not have inclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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,	Behavioral: Educational interventions; The educational interventions will consist in:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate prevalence of childhood overweight and/or obesity	Weight and height will be combined to report BMI in kg/m^2	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.	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)	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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)	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.	Baseline, 6 and 12 months

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research
• Collaborators: University of Pavia
• Investigators: Principal Investigator: Carlotta Franchi, PhD, Mario Negri Institute for Pharmacological Research; Principal Investigator: Marta Baviera, PharmDr, Mario Negri Institute for Pharmacological Research; Principal Investigator: Maria Vittoria Conti, MSc, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Primary schools; Childhood Obesity Prevention; Educational Interventions; Childhood Obesity determinants
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: IRFMN-8979; F13C22001210007 (Other Identifier: University of Pavia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No