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Bimbingamba Zerosix Third Phase: Studying Communities (Bimbingamba)

Primary Purpose

Obesity, Childhood Obesity, Weight Loss

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Promotion of Healthy Nutrition and Physical Activity
Sponsored by
Azienda Ospedaliero Universitaria Maggiore della Carita
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Childhood Obesity

Eligibility Criteria

2 Days - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Eastern PiedmontRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Children resident in the Municipality of Mondovì (Intervention group)

Children resident in the Municipality of Savigliano (Control group)

Arm Description

Recruiting of 1000 children (more or less) with ages between 0 and 5 years resident in the Municipality of Mondovì. Eligible subjects are children with a date of birth between 1/1/2018 and 31/12/2022 (subjects born in 5 years prior to the start of the project), plus a cohort of newborn between 01/1/2023 and 21/6/2023. Children of both sex and of any ethnicity could be enrolled in the trial. Moreover, parents of eligible and enrolled children are also considered in-study subjects.

Recruiting of 1000 children (more or less) with ages between 0 and 5 years resident in the Municipality of Savigliano. Eligible subjects are children with a date of birth between 1/1/2018 and 31/12/2022 (subjects born in 5 years prior to the start of the project), plus a cohort of newborn between 01/1/2023 and 21/6/2023. Children of both sex and of any ethnicity could be enrolled in the trial. Moreover, parents of eligible and enrolled children are also considered in-study subjects.

Outcomes

Primary Outcome Measures

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.
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
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
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.
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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
April 12, 2023
Last Updated
May 22, 2023
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Collaborators
Compagnia di San Paolo (Torino)
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1. Study Identification

Unique Protocol Identification Number
NCT05859867
Brief Title
Bimbingamba Zerosix Third Phase: Studying Communities
Acronym
Bimbingamba
Official Title
Bimbingamba Zerosix Third Phase: Studying Communities
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
April 15, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Collaborators
Compagnia di San Paolo (Torino)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood Obesity, Weight Loss, Life Style, Healthy
Keywords
Childhood Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children resident in the Municipality of Mondovì (Intervention group)
Arm Type
Experimental
Arm Description
Recruiting of 1000 children (more or less) with ages between 0 and 5 years resident in the Municipality of Mondovì. Eligible subjects are children with a date of birth between 1/1/2018 and 31/12/2022 (subjects born in 5 years prior to the start of the project), plus a cohort of newborn between 01/1/2023 and 21/6/2023. Children of both sex and of any ethnicity could be enrolled in the trial. Moreover, parents of eligible and enrolled children are also considered in-study subjects.
Arm Title
Children resident in the Municipality of Savigliano (Control group)
Arm Type
No Intervention
Arm Description
Recruiting of 1000 children (more or less) with ages between 0 and 5 years resident in the Municipality of Savigliano. Eligible subjects are children with a date of birth between 1/1/2018 and 31/12/2022 (subjects born in 5 years prior to the start of the project), plus a cohort of newborn between 01/1/2023 and 21/6/2023. Children of both sex and of any ethnicity could be enrolled in the trial. Moreover, parents of eligible and enrolled children are also considered in-study subjects.
Intervention Type
Other
Intervention Name(s)
Promotion of Healthy Nutrition and Physical Activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of weigh/overweight subjects
Description
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.
Title
Rate of Mediterranean Diet (MD) adherence
Description
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.
Title
Physical activity level
Description
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.
Title
Adherence to Mediterranean Diet
Description
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.
Title
Nutritional habits
Description
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.
Time Frame
Changes in nutritional habits between time 0 and 24 months
Title
Access rate to Emergency Room (ER) and Pediatricians of Free Choice (PFC)
Description
Comparison in number of times visiting ER and PFC among the intervention and control group at times 0 and 24 months.
Time Frame
Changes in the ER and PFC accesses at time 0 and 24 months.
Title
Change in physiological parameters
Description
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
Time Frame
Variation in Likert scale points at time 0 and 24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flavia Prodam
Phone
+39 0321 660 693
Email
flavia.prodam@med.uniupo.it
First Name & Middle Initial & Last Name or Official Title & Degree
Piermarco Ferraresu
Phone
+39 0131283819
Email
piermarco.ferraresi@unito.it
Facility Information:
Facility Name
University of Eastern Piedmont
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia Prodam, Prof.MD
Phone
+39 0321 660 693
Email
flavia.prodam@med.uniupo.it
First Name & Middle Initial & Last Name & Degree
Piermarco Ferraresi, Prof.
Phone
+39 0131283819
Email
piermarco.ferraresi@unito.it

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Links:
URL
https://www.cpo.it/it/articles/show/studio-andromeda-la-tua-storia-per-uno-screening-migliore/
Description
Piedmont Reference Center for Oncological Epidemiology and Prevention in Piedmont (CPO). Andromeda study

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Bimbingamba Zerosix Third Phase: Studying Communities

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