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

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Participants enrolled: 327
• From 14 Jun 2021 to the primary completion date, 15 Jan 2024
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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