Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05966051
Other study ID # IRFMN-8979
Secondary ID F13C22001210007
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05437406 - Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC) N/A
Completed NCT03297541 - Healthy Kids I-PAL N/A
Completed NCT05527938 - Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children N/A
Completed NCT05501392 - South Texas Early Prevention Studies PreK N/A
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Active, not recruiting NCT03342092 - Early Adiposity Rebound Amongst 4-y.o. Children and Overweight Risk Amongst 11-y.o Children : Third Phase of a Cohort Study in Franche-Comté N/A
Completed NCT06239662 - Therapeutic Education Groups for Childhood Obesity N/A
Not yet recruiting NCT02889406 - Motivation Approach for Childhood Obesity Treatment N/A
Withdrawn NCT02767830 - Cleveland Kids Run N/A
Completed NCT03245164 - The Effects of Group Exercise and Basketball on Obese Children N/A
Completed NCT02559076 - The Eat Right Emirates Healthy Lifestyle Study N/A
Completed NCT02484976 - Brain Activation and Satiety in Children: Functional Magnetic Resonance Imaging N/A
Completed NCT01977105 - Healthy Growth Abbreviated Pilot Study N/A
Completed NCT02087774 - Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children N/A
Completed NCT01789671 - Peer Counseling in Family-Based Treatment for Childhood Obesity N/A
Completed NCT01821313 - CASH- Children Active to Stay Healthy N/A
Completed NCT01849315 - Effects of Physical Activity on Disease Risk Factors N/A
Completed NCT02637752 - Nutrition and Physical Activity Counselling N/A
Completed NCT02799433 - Evaluation of the Healthy Apple Program in San Francisco N/A
Completed NCT00854334 - Co-existent Obstructive Sleep Apnea (OSA) and Obesity: Finding Non-exercise Activity Thermogenesis (NEAT) Targets for Intervention N/A