Bimbingamba Zerosix Third Phase: Studying Communities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-5
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Promotion of Healthy Nutrition and Physical Activity
Other interventionThrough 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.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Children resident in the Municipality of Mondovì (Intervention group)Experimental treatment 1 intervention
Group B: Children resident in the Municipality of Savigliano (Control group)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of weigh/overweight subjects
Variation in total body weight in children belonging to the intervention or control groups at times 0 and 24 months.
Time frame
Change in body weight at time 0 and 24 months.2
Rate of Mediterranean Diet (MD) adherence
Variation in nutritional habits (Western Diet to Mediterranean Diet) in both control and intervention groups at times 0 and 24 months. Habits in consuming MD are evaluated with KIDMED (Mediterranean Diet Quality Index) questionnaire, the scores are as follows: total score = 12 points lower than 3 = low adherence to MD between 4-7= moderate adherence to MD higher than 8= high adherence to MD
Time frame
Change in KIDMED score at time 0 and 24 months.3
Physical activity level
Variation in physical activity level assessed by the International Physical Activity Questionnaire "IPAQ" in both control and intervention groups at time t0 and 24 months. IPAQ scale is based on MET (minutes of physical activity per week): lower than 30 minutes per day = low level of physical activity equal to 30 minutes per day= moderate level of physical activity higher than 3000 minutes per week (MET)= high level of physical activity
Time frame
Change in IPAQ score at time 0 and 24 months.4
Adherence to Mediterranean Diet
Evaluate the Mediterranean Diet adherence (consumption of fruit, vegetables, nuts, extra virgin olive "EVO" oil, and so on) before and after the intervention in both control and intervention groups. The questionnaire will be performed on time t0 (time of enrollment) and time t24 (24 months later). This questionnaire gives as results the percentage of macronutrient and micronutrient consumption and the association with Mediterranean Diet adherence.
Time frame
Changes in the adherence of Mediterranean Diet between 0 and 24 months.Sponsors and contacts
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Azienda Ospedaliero Universitaria Maggiore della Carita
Lead sponsor
Compagnia di San Paolo
Collaborator
Source ClinicalTrials.gov