Bimbingamba: an assessment of the effectiveness of a program aimed at improving lifestyles of children aged 0-6.

Last registered on March 30, 2023
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Pre-Trial

Trial Information

General Information

Title
Bimbingamba: an assessment of the effectiveness of a program aimed at improving lifestyles of children aged 0-6.
RCT ID
AEARCTR-0011016
Initial registration date
March 21, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
March 30, 2023, 2:57 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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Primary Investigator

Name
Ainoa Aparicio Fenoll
Affiliation
University of Turin and Collegio Carlo Alberto
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Other Primary Investigator(s)

PI Name
Flavia Coda Moscarola
PI Affiliation
University of Eastern Piedmont
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PI Name
Flavia Prodam
PI Affiliation
University of Eastern Piedmont
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PI Name
Pier Marco Ferraresi
PI Affiliation
University of Eastern Piedmont
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Additional Trial Information

Status
In development
Start date
2022-04-15
End date
2025-12-31
Keywords
Behavior, Education, Health, Welfare
Additional Keywords
Nutrition, health risk factors, childhood obesity-related diseases, community-based prevention interventions
JEL code(s)
I10, I18, C93, I20
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Essential obesity, even in childhood, has a multifactorial origin, being mainly determined by the interaction of environmental factors, primarily an incorrect lifestyle, and individual factors, including genetic risk factors. The return to a "normal" weight condition, particularly if an excess weight has arisen in the first years of life, seems very diļ¬ƒcult to achieve due to mechanisms that are not only behavioral but also related to epigenetic imprinting characterized by a trans-generational effect. Numerous risk factors that influence the development and maintenance of an obese phenotype act as early as prenatally and particularly in the first 1000 days of life.
While there is wide evidence on the development of childhood obesity-related diseases, there is scarce evidence on what interventions are proven to be effective and long-lasting. The observation that childhood obesity in developed countries presents itself with clear social and geographic gradients justifies primary prevention interventions implemented at family and community levels.
There are numerous interventions for pediatric lifestyle promotion, particularly those aimed at primary and middle school; few, however, have targeted the 0-6 age group. Furthermore, most of lifestyle promotion interventions have not been measured in terms of effectiveness.
Bimbingamba is an initiative aimed at promoting healthy diet and physical exercise among children in the 0-6 age group. The initiative will take place in a municipality in Northern Italy and will involve the entire community of resident children; the general objective of this project is to assess the effectiveness of such an intervention.
The expected result is twofold:
- The description of weight status and its time trend in the 0-6 age group, by socio-economic level, parents' characteristics, and lifestyle of the children and their families.
- The estimate of the effectiveness of community-based interventions on lifestyles and bio-metrics, health, well-being outcomes, and soft-skills in the 0-6-year-old population.
External Link(s)

Registration Citation

Citation
Aparicio Fenoll, Ainoa et al. 2023. "Bimbingamba: an assessment of the effectiveness of a program aimed at improving lifestyles of children aged 0-6.." AEA RCT Registry. March 30. https://doi.org/10.1257/rct.11016-1.0
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Experimental Details

Interventions

Intervention(s)
The interventions are designed by experts and local stakeholders (municipality, local healthcare agencies and professionals, schools, pediatricians, third sector bodies, etc.).
The interventions include:
- Randomized information on healthy food and lifestyles - Educational and entertainment activities on food
- Educational and entertainment activities on sports and active hobbies - Dissemination activities at main social events
- Small interventions on local infrastructure (e.g. playgrounds)
Intervention Start Date
2023-05-08
Intervention End Date
2025-04-20

Primary Outcomes

Primary Outcomes (end points)
- Body mass index
- Knowledge of the basics of a healthy diet and lifestyle
- Diet and lifestyle
- Correlation between soft skills and healthy lifestyles.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Target population
The study targets children aged 0-6 years residing in two municipalities located in Piedmont. All children born between 1/1/2018 and 31/12/2022, plus a cohort of newborns between 01/1/2023 and 31/6/2023 will be considered eligible.
Parents of eligible and enrolled children are also considered study subjects.

Experimental phases
1. Enrollment and baseline data collection
- population will be invited to engage in the program, download the APP and answer the pre-treatment questionnaires. The project will be promoted by employing dissemination material in various places habitually frequented by the potentially interested population: birth centers, vaccination centers, health advisory centers, schools (nursery schools and kindergartens), pediatricians, fairs, and other events.
- enrolled families will be invited to bring the children to their pediatrician for a health check and the evaluation of their BMI
- enrolled children attending nursery schools and kindergartens will participate in a "health day" in which they will be involved in games aimed at eliciting their preferences about food and their friendship relationships

2. Treatment
The treatment consists of:
- A communication campaign conveyed through the APP on healthy food and lifestyles. The contents of messages are validated by the medical staff involved in the project.
- A educational and experiential activities plan for families and children, tailored to different age groups.

The first component (communication) is randomized at the family level; the second component (activities) is randomized at the municipality level: the treated municipality has been randomly chosen between two similar ones, located in the South-East of Piedmont and sharing the same socio-demographic and geographic characteristics.

3. Post-treatment data collection
- enrolled children attending nursery schools and kindergartens will participate in a "health day" in which they will be involved in games aimed at eliciting their preferences about food and their friendship relationships
- enrolled families will be invited to answer the post-treatment questionnaires
- enrolled families will be invited to bring the children to their pediatrician for a health check and the evaluation of their BMI

Participation in all phases of the experiment will be rewarded with a shopping voucher.
Experimental Design Details
Not available
Randomization Method
Unconditional randomization in office by a computer.
Randomization Unit
Households - Municipalities
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
We expect the involvement of a minimum of about 200 families.
Sample size: planned number of observations
We expect to involve about 400 children.
Sample size (or number of clusters) by treatment arms
about 50% treated and 50% controlled.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
ETHICS COMMITTEE of Collegio Carlo Alberto
IRB Approval Date
2023-02-27
IRB Approval Number
N/A
Analysis Plan