Bimbingamba Zerosix Third Phase: Studying Communities

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Childhood obesity is increasing in the last years especially in developed countries, and, as well as adult obesity, is related to the development of pathologies. Unfortunately, the restoration of a normal weight condition, if the ponderal excess rose in the first years of life, seems very difficult. Despite the importance of this issue, there is a paucity of evidence demonstrating effective interventions in reducing weight over time. The observation that in developed countries childhood obesity appears with evident social and geographical gradients justifies the implementation of inter-sectoral interventions of primary prevention, to be declined at the contextual level: family and community. Nowadays, there are numerous interventions for the promotion of lifestyle in pediatric age, in particular, those aimed at primary school and adolescence. On the other hand, few interventions were directed at the 0-7 age group. Therefore, this community intervention trial involved the pediatric population (aged 0-7 years) and their families, and it is aimed at the prevention of obesity and the restoring normal weight through community interventions aimed at improving lifestyles and with them the bio-metric parameters, health and well-being outcomes and soft skills in the population aged 0-7 years. The target population is children aged 0-7 years resident in the two municipalities (Mondovì and Savigliano), respectively selected as Intervention and Control Common. Totally, to conduct this study 2000 children, of both sex, will be enrolled (near 1000 for each of the two Municipalities).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 days
Maximum Age: 5
Healthy Volunteers: f
View:

• Children aged 0-5 year of both sex resident in the two Municipalities under evaluation

• children having date of birth between 1/1/2018 and 31/12/2022 (subjects born 5 years prior to the start of the project)

• newborns between 01/1/2023 and 21/6/2023 residing in the two municipalities under study.

Locations
Other Locations
Italy
University of Eastern Piedmont
RECRUITING
Novara
Contact Information
Primary
Flavia Prodam
flavia.prodam@med.uniupo.it
+39 0321 660 693
Backup
Piermarco Ferraresu
piermarco.ferraresi@unito.it
+39 0131283819
Time Frame
Start Date: 2023-04-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 2000
Treatments
Experimental: Children resident in the Municipality of Mondovì (Intervention group)
Recruiting of 1000 children (more or less) with ages between 0 and 5 years resident in the Municipality of Mondovì.~Eligible subjects are children with a date of birth between 1/1/2018 and 31/12/2022 (subjects born in 5 years prior to the start of the project), plus a cohort of newborn between 01/1/2023 and 21/6/2023.~Children of both sex and of any ethnicity could be enrolled in the trial.~Moreover, parents of eligible and enrolled children are also considered in-study subjects.
No_intervention: Children resident in the Municipality of Savigliano (Control group)
Recruiting of 1000 children (more or less) with ages between 0 and 5 years resident in the Municipality of Savigliano.~Eligible subjects are children with a date of birth between 1/1/2018 and 31/12/2022 (subjects born in 5 years prior to the start of the project), plus a cohort of newborn between 01/1/2023 and 21/6/2023.~Children of both sex and of any ethnicity could be enrolled in the trial.~Moreover, parents of eligible and enrolled children are also considered in-study subjects.
Related Therapeutic Areas
Sponsors
Collaborators: Compagnia di San Paolo
Leads: Azienda Ospedaliero Universitaria Maggiore della Carita

This content was sourced from clinicaltrials.gov