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

NCT05966051 | Completed

• 2 other identifiers: IRFMN-8979F13C22001210007
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Feasibility of multidimensional school-based educational interventions

  6 months

• Investigation of changes in adherence to Mediterranian diet

  Baseline, 6 and 12 months

• Assessment of changes of the consumption of ultra-processed food by children

  Baseline, 6 and 12 months

• Investigation of changes of family lifestyles

  Baseline, 6 and 12 months

Study Arms (1)

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

Interventions

Educational interventions BEHAVIORAL

The educational interventions will consist in:

Children attending primary school

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead
• University of Pavia: collaborator

Study Sites (1)

Istituto Comprensivo Luigi Cadorna

Milan, MI, 20148, Italy

Location

Related Publications (1)

• 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.

  PMID: 39475855 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: July 28, 2023
• Study Start: October 18, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 1, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

IT (1)