RecruitingNot ApplicableNCT05859867

Bimbingamba Zerosix Third Phase: Studying Communities


Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Enrollment

2,000 participants

Start Date

Apr 15, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 2 DaysMax Age: 5 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria2

  • Residence/domicile in the municipalities under investigation, for a period of time less than 6 months following recruitment;
  • Recruitment of the child in other intervention trials of any nature.

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Interventions

OTHERPromotion of Healthy Nutrition and Physical Activity

Through scheduled and specific activities, enrolled subjects receive information for the promotion of the Mediterranean diet and Mediterranean lifestyle habits, according to the pyramid of the Mediterranean diet. In addition, subjects receive general recommendations about the promotion of regular recreational motor activity, the pyramid of physical activity for pediatric age, and free games appropriate to age. These activities are conducted by professionals in the food (nutritionists) and sports sectors and are aimed in the preparation of simple recipes repeatable at home, and in motor play activities to encourage physical activity. Information regarding clinical, and socio-demographic parameters and family habits will be collected through validated questionnaires.


Locations(1)

University of Eastern Piedmont

Novara, Italy

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NCT05859867


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