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

Childhood Obesity Clinical Trial

— LIVELY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05966051
• Other study ID #: IRFMN-8979
• Secondary ID: F13C22001210007
• Status: Active, not recruiting
• Start date: October 18, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: January 2024
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 226
• Est. completion date: June 1, 2025
• Est. primary completion date: October 1, 2024
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

• children 6-11 years

• children whose parents will provide written consent to participate.

Exclusion Criteria:

• Children who do not have inclusion criteria.

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Educational interventions
The educational interventions will consist in:

Locations

Country	Name	City	State
Italy	Istituto Comprensivo Luigi Cadorna	Milan	MI

Sponsors (2)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research	University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate prevalence of childhood overweight and/or obesity	Weight and height will be combined to report BMI in kg/m^2	Baseline
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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