Obesity Clinical Trial
— BimbingambaOfficial title:
Bimbingamba Zerosix Third Phase: Studying Communities
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).
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | December 31, 2025 |
Est. primary completion date | April 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Days to 5 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | University of Eastern Piedmont | Novara |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero Universitaria Maggiore della Carita | Compagnia di San Paolo (Torino) |
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change in body weight at time 0 and 24 months. | |
Primary | 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 |
Change in KIDMED score at time 0 and 24 months. | |
Primary | 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 |
Change in IPAQ score at time 0 and 24 months. | |
Primary | 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. |
Changes in the adherence of Mediterranean Diet between 0 and 24 months. | |
Primary | Nutritional habits | Nutritional habits will be evaluated in both the control and intervention groups through the use of the Andromeda questionnaire. This questionnaire will be performed at time 0 (during the enrollment) and 24 months later.
Andromeda is a questionnaire that collects information on eating habits in terms of the frequency of food consumption in the last year. Therefore, the questionnaire assesses dietary habits before the start of the observation period (t0) and 24 months (two years) after the observation or intervention period. There is no score for this questionnaire, it divides food into macro-categories giving information about the nutrients assumption. |
Changes in nutritional habits between time 0 and 24 months | |
Primary | Access rate to Emergency Room (ER) and Pediatricians of Free Choice (PFC) | Comparison in number of times visiting ER and PFC among the intervention and control group at times 0 and 24 months. | Changes in the ER and PFC accesses at time 0 and 24 months. | |
Primary | Change in physiological parameters | Variation in self-confidence, self-control, and socialization level in control and intervention groups at times 0 and 24 months. These physiological parameters are evaluated through the use of Likert scale having 5 points:
Very satisfied. Moderately satisfied. Neither satisfied nor dissatisfied. Moderately dissatisfied. Very dissatisfied |
Variation in Likert scale points at time 0 and 24 months. |
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