Actively Recruiting

Phase Not Applicable
Age: 2Days - 5Years
All Genders
ID05859867

Bimbingamba Zerosix Third Phase: Studying Communities for Childhood Obesity Prevention and Lifestyle Improvement in Children Aged 0-7 Years

Led by Azienda Ospedaliero Universitaria Maggiore della Carita · Updated on 2024-08-01

2000

Participants Needed

1

Research Sites

37 weeks

Total Duration

On this page

Sponsors

A

Azienda Ospedaliero Universitaria Maggiore della Carita

Lead Sponsor

C

Compagnia di San Paolo

Collaborating Sponsor

AI-Summary

What this Trial Is About

Childhood obesity is increasing, particularly in developed countries, and is linked to various health problems. This research focuses on preventing obesity and helping restore normal weight in children aged 0-7 years through community-based interventions. The study compares two municipalities, with one receiving the intervention and the other serving as a control, aiming to improve lifestyle habits, biometric data, health outcomes, and soft skills in young children. The study involves children and their families in two Italian municipalities: Mondovì (intervention group) and Savigliano (control group). Around 2000 children aged 0-7 years will be enrolled, with about 1000 in each municipality. Interventions include organized community events where children and parents participate in nutrition education focused on the Mediterranean diet, healthy cooking activities, and physical exercise led by nutritionists, personal trainers, and educators. Participants will be recruited through events, birth centers, kindergartens, and vaccination centers. Data will be collected at the start and after 24 months using questionnaires, clinical measurements, and health records. The main outcomes include changes in weight status, adherence to the Mediterranean diet, physical activity levels, nutritional habits, and healthcare access rates. Data analysis will compare differences between the intervention and control groups over two years.

CONDITIONS

Brief Title

Bimbingamba Zerosix Third Phase: Studying Communities

Who Can Participate

Age: 2Days - 5Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 0-5 years of both sexes residing in the two municipalities under study
  • Children born between 1/1/2018 and 31/12/2022
  • Newborns between 01/1/2023 and 21/6/2023 residing in the two municipalities under study
Not Eligible

You will not qualify if you...

  • Residence or domicile in the municipalities under study for less than 6 months after recruitment
  • Participation of the child in other intervention trials of any kind

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 24 months

Participants attend organized events where children and their families receive education on the Mediterranean diet and healthy cooking guided by nutritionists, as well as participate in recreational and motor activities to promote physical activity.

Multiple scheduled activities and events over the study period

Follow-up

Duration - At 24 months (end of study)

Participants' clinical, socio-demographic data, and lifestyle habits are assessed at the end of the study to evaluate changes and effectiveness of the intervention.

1 visit (in-person) for post-intervention data collection

Trial Site Locations

Total: 1 location

1

University of Eastern Piedmont

Novara, Italy, 28100

Actively Recruiting

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Research Team

F

Flavia Prodam

P

Piermarco Ferraresu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Adherence to the Mediterranean Diet among School Children and Adolescents Living in Northern Italy and Unhealthy Food Behaviors Associated to Overweight.

Francesca Archero, Roberta Ricotti, Arianna Solito...

https://pubmed.ncbi.nlm.nih.gov/30231531

Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children up to the age of 6 years.

Jill L Colquitt, Emma Loveman, Claire O'Malley...

https://pubmed.ncbi.nlm.nih.gov/26961576

Engaging Fathers in Early Obesity Prevention During the First 1,000 Days: Policy, Systems, and Environmental Change Strategies.

Kirsten K Davison, Adam Gavarkovs, Brent McBride...

https://pubmed.ncbi.nlm.nih.gov/30900405

Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts.

Ramón Estruch, Emilio Ros, Jordi Salas-Salvadó...

https://pubmed.ncbi.nlm.nih.gov/29897866

Within- and between-cohort variation in measured macronutrient intakes, taking account of measurement errors, in the European Prospective Investigation into Cancer and Nutrition study.

Pietro Ferrari, Rudolf Kaaks, Michael T Fahey...

https://pubmed.ncbi.nlm.nih.gov/15466504

The ANDROMEDA prospective cohort study: predictive value of combined criteria to tailor breast cancer screening and new opportunities from circulating markers: study protocol.

Livia Giordano, Federica Gallo, Elisabetta Petracci...

https://pubmed.ncbi.nlm.nih.gov/29166878