Clinical trial NCT05859867: Bimbingamba Zerosix Third Phase: Studying Communities
Official title: Bimbingamba Zerosix Third Phase: Studying Communities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Childhood Obesity
Weight Loss
Life Style, Healthy
Keywords: Childhood Obesity
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
Collaborators: name: Compagnia di San Paolo
First posted: 2023-05-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Bimbingamba is an initiative promoted by "Fondazione Compagnia di San Paolo" with the aim of achieving healthy nutrition and physical exercise among children, aged 0-7 years. The initiative will take place in Mondovì (Cuneo, Italy), selected as the intervention Municipality, and will involve resident children with their families. Due to the common interest in the topic, Compagnia di San Paolo has requested the University of Eastern Piedmont of collaborating on the project.

As reported by literature, childhood obesity presents a multifactorial origin being determined by the interaction between environmental and genetic factors. Increased habits in consuming "junk foods", sweetened beverages, unhealthy lifestyles, and low levels of physical activity are the major driving factors for the development of obesity during childhood. The restoration of a normal weight condition, especially if the ponderal excess rose in the first years of life, seems very difficult to achieve not only because of behavioral mechanisms but also of epigenetic imprinting. The interest of this study is the prevention of the obese phenotype in children together with the restoration of normal weight. There are a great number of interventions centered on the promotion of a healthy lifestyle in adolescents, but few of these are focused on infancy, especially interventions directed to the 0-7 age group. According to reported knowledge, preventing obesity in childhood is important for reducing the risk of obesity among adolescents and adults. Therefore preventing/reducing the related comorbidities.

This intervention study will be conducted in two Italian Commons, Mondovì and Savigliano, respectively selected as the interventional Municipality and control Municipality. The study will include at least 200 children between 0-7 years with their families living and residing in one of the two cities. The main objectives of this study will be the description of weight status during the time in the 0-7 aged group in relation to the socio-economic factors, parental parameters, families, and lifestyle habits. As a secondary objective, this study aims to evaluate the effectiveness of interdisciplinary interventions in the community. Therefore, evaluating lifestyle promotion, health improvement, and soft skills acquisition in the 0-7 aged group.

Interventions will be administered during organized events involving the participation of children and their families together with the presence of specialized staff (nutritionists, personal trainers, educators). During these days children will be educated in the Mediterranean diet and healthy cooking (preparing simple meals with their parents) guided by nutritionists and will be involved in recreational and motor activities to promote physical activity.

Participants' recruiting will occur during the organized events, in places of birth, kindergarten, and vaccination centers through informative materials. On the occasion of the first meeting, those parents apparently interested will be given the materials and the link for the application (https://bimbingambazerosei.app.interacta.space/) through which join the projects and fill out the informed consent for them and their children. Recruiting period will start in April 2023.

Data collection will be performed by the specialized personnel by using specific and validated questionnaires, by taking clinical and non-clinical data, and by data arriving from health sources (i.e.: emergency accesses). All data will be registered in REDCap.

The study is thought to last 2 years, pre-intervention data will be collected at time (t) 0 (during recruiting), while post-intervention data will be collected at t24 (end of the study). Among the possible outcomes of treatment have been identified the percentage of children that are average weight or overweight, the number of children having a Mediterranean diet regimen before and after the educational period, the kind of family diet, and the level of physical activity.

Obtained data will be analyzed with statistical analysis (i.e. ANOVA and t.test) in order to identify the differences between the intervention and the control group. The final aim of the study is to obtain different data among the two cohorts regarding the prevalence of risk factors related to obesity, among the adherence of children and their families to the Mediterranean diet, differences in anthropometric and clinical parameters, and the ability of parents in distinguish healthy and unhealthy habits for their children.

The entire study will be conducted according to the Helsinki Declaration and following the Standards of Good Clinical Practice of the European Union.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Rate of weigh/overweight subjects
timeFrame: Change in body weight at time 0 and 24 months.
measure: Rate of Mediterranean Diet (MD) adherence
timeFrame: Change in KIDMED score at time 0 and 24 months.
measure: Physical activity level
timeFrame: Change in IPAQ score at time 0 and 24 months.
measure: Adherence to Mediterranean Diet
timeFrame: Changes in the adherence of Mediterranean Diet between 0 and 24 months.
measure: Nutritional habits
timeFrame: Changes in nutritional habits between time 0 and 24 months
measure: Access rate to Emergency Room (ER) and Pediatricians of Free Choice (PFC)
timeFrame: Changes in the ER and PFC accesses at time 0 and 24 months.
measure: Change in physiological parameters
timeFrame: Variation in Likert scale points at time 0 and 24 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Novara
country: Italy
facility: University of Eastern Piedmont
Study officials:
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