Bimbingamba Zerosix Third Phase: Studying Communities
NCT05859867 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000
Last updated 2024-08-01
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).
Conditions
- Obesity
- Childhood Obesity
- Weight Loss
- Life Style, Healthy
Interventions
- OTHER
-
Promotion 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.
Sponsors & Collaborators
-
Compagnia di San Paolo
collaborator OTHER -
Azienda Ospedaliero Universitaria Maggiore della Carita
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Days
- Max Age
- 5 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-15
- Primary Completion
- 2025-04-15
- Completion
- 2025-12-31
Countries
- Italy
Study Locations
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