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Evaluation of the Efficacy of an App for Parents to Promote Healthy Life-styles in Children: the CoSIE Trial

NCT04915092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2025-06-25

No results posted yet for this study

Summary

The objective of the study is to evaluate the effectiveness of the app in terms of changing lifestyles both related to nutrition and physical activity. The study is also aimed at evaluating the usability and the degree of acceptance of the app among parents.

The primary objective will be assessed in terms of the change in the consumption of sugary drinks and high-calorie food and in terms of time spent in front of a screen.

The secondary objectives are the evaluation of BMI (percentile and z-score) and waist circumference and the evaluation of the usability of the app.

STUDY DESIGN The study is a randomized control trial. Both parents and children are recruited.

* Family paediatricians during the health balance of 3 or 5 years old (children between 3 and 6.5 years old)
* Sport medicine during the visits for sport ability (children between 7 and 11 years old)
* Pediatric Endocrinology and Diabetology of the Santa Maria Hospital during routine visits (children between 5 and 11 years old)

When the study is presented to families, few clinical information are collected on the electronic platform designed for enrollment and randomization:

* Child weight and height
* Child waist circumference

More information about children and parents are collected (through questionnaire).

The families (both treatment and control ) are contacted after 12 month and after 24 months from the recruitment to answer to a questionnaire on lifestyle habits (food and physical activity) of the child and app utilization

During this visit also child weight, height and waist circumference will be collected.

Intervention group The app is explained and installed during the recruitment to the family in the intervention group.

Some families in this group will be selected to take part to the qualitative research.

Control group Every months during the first year of study a newsletter is sent only to the members of the control group.

Conditions

  • Childhood Obesity

Interventions

DEVICE

CoSIE app

The app is a mobile phone application compatible with both iOS and Android operating system. Parents are able to register their children and to keep track of their weight status and activities. The app include five themes: child development, physical activity, healthy food, critical situations, BMI. Push notification on healthy behaviours, on important event taking place in the province of Reggio Emilia, on food advices based on seasonality and on party tips are constantly delivered by the app.

Sponsors & Collaborators

  • Azienda USL Reggio Emilia - IRCCS

    lead OTHER_GOV

Principal Investigators

  • Paolo Giorgi Rossi, phd · Azienda USL-IRCCS Reggio Emilia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2024-01-15
Completion
2024-01-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04915092 on ClinicalTrials.gov