Childhood ObesityCoSIENCT04915092
Evaluation of the Efficacy of an App for Parents to Promote Healthy Life-styles in Children: the CoSIE Trial
A study testing CoSIE app in people with Childhood Obesity, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- CoSIE app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jun 2021to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- parents of children aged 3 to 11 presneting for a new well child visit or for a sport medicin visit or presenting for a childhood obesity visit at the AUSL Reggio Emilia clinics, including family pediatricians clinics.
Who cannot join
- Families resident outside the Province of Reggio Emilia
- Parents with no comprehension of the Italian language
- Children inside a program for obesity cure or prevention. The program are:
- the GET program (a program coordinated by the hospital pediatric unit in which obese children follow a group intervention),
- the BMInforma program (in which overweight girls from 5 to 7 years old follow a counselling proposed by the family paediatrician),
- the second level medical clinic in which obese children with pathologic condition are cured
- Children with severe obesity previously diagnosed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Co-creation of Service Innovation - Evaluation of the Efficacy of an App for Parents to Prevent Childhood Obesity and Promote Healthy Life-styles: CoSIE Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Childhood obesity is a highly prevalent condition and together with the behaviours associated with it, such as improper diet and physical inactivity, it generates a high burden of disease in adulthood.
In recent years, it is increasing the use of mobile devices in support of health prevention and promotion strategies. In a primary care setting these new technologies offer the opportunity to open a two-way communication channel between parents and institutions and can help by adapting the intervention and framing the message according to the needs of each family.
Since 2010, the Reggio Emilia AUSL has started a research and interventions program aimed at preventing childhood obesity. The program has adopted a multilevel and multi-setting strategy for primary prevention (BMInforma Program).
Since 2017, together with the University of Bologna and the regional company Lepida2000, the Local Health Authority is part of the Co-creation of Service Innovation in Europe project (CoSIE Project), a project funded by the European Union with a Horizon 2020 call coordinated by the University of Turku, Finland. The CoSIE project promotes the co-creation of public services through the involvement of citizens and other interested parties in the definition of objectives and delivery methods.
The project is divided into nine pilot projects and the Italian pilot project, carried out in the province of Reggio Emilia, is part of the AUSL program for the prevention of childhood obesity. The aim of the pilot project is to create a network between the services involved in the prevention and treatment of obesity and, at the same time, it aims to create an app that can help promote a healthy lifestyle. The app was designed and created with a co-creation process.
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. Furthermore,an aim of the study is to evaluate 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. The recruitment is done by some members of the CoSIE project Consulting Committee:
- 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
- Being tested
- CoSIE app
- Keywords
- mhealth, app, obesity, prevention
- Medical subject headings
- Pediatric Obesity, Alzheimer Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoSIE appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: CoSIE app |
| Control group | No intervention | Every months during the first year of study a newsletter is sent only to the members of the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in consumption of sugar - sweetened beverages and juice, first year
Endpoint: number per week Outcome: Delta 12m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Measured: 12 months
Change in consumption of sugar - sweetened beverages and juice, second year
Endpoint: number per week Outcome: Delta 24m - baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Measured: 24 months
Change in consumption of hypercaloric foods like fried food, salty snacks and sweet snacks/candies, first year
Endpoint: number per week Outcome: Delta 12m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Measured: 12 months
Change of consumption of hypercaloric foods like fried food, salty snacks and sweet snacks/candies, second year
Endpoint: number per week Outcome: Delta 24m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Measured: 24 months
Change in screen time spent by children, first year
Endpoint: Minutes of screen time per day Outcome: Delta 12m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Measured: 12 months
Change in screen time spent by children, second year
Endpoint: Minutes of screen time per day Outcome: Delta 24m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Measured: 24 months
Secondary outcomes (4)
BMI centile of children after the first year
Endpoint: BMI centile Outcome: Delta 12m-baseline Test/analysis: Difference between group means Source: FU visits
Measured: 12 months
BMI centile of children after the second year
Endpoint: BMI centile Outcome: Delta 24m-baseline Test/analysis: Difference between group means Source: FU visits
Measured: 24 months
Acceptability
How much parents accept the concept of using an app to guide their habits in children education Test/analysis: qualitative analysis Source: Interviews
Measured: after at 12 months of app utilization
Usability
How much each single app function is used and is perceived as useful by parents Test/analysis: qualitative analysis Source: Interviews
Measured: after at 12 months of app utilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start14 Jun 2021
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Families in the intervention arm will receive the app
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Paolo Giorgi Rossi, phd, Principal investigator, Azienda USL-IRCCS Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915092
- Sponsor's protocol ID
- ID:360 - CoSIE app
- Acronym
- CoSIE
- Status last verified
- Jan 2024
- First submitted
- 16 Nov 2020
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giorgi Rossi P, Ferrari F, Amarri S, Bassi A, Bonvicini L, Dall'Aglio L, Della Giustina C, Fabbri A, Ferrari AM, Ferrari E, Fontana M, Foracchia M, Gallelli T, Ganugi G, Ilari B, Lo Scocco S, Maestri G, Moretti V, Panza C, Pinotti M, Prandini R, Storani S, Street ME, Tamelli M, Trowbridge H, Venturelli F, Volta A, Davoli AM; Childhood Obesity Prevention Working Group. Describing the Process and Tools Adopted to Cocreate a Smartphone App for Obesity Prevention in Childhood: Mixed Method Study. JMIR Mhealth Uhealth. 2020 Jun 8;8(6):e16165. doi: 10.2196/16165.
PubMed 32357123
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-creation of Service Innovation - Evaluation of the Efficacy of an App for Parents to Prevent Childhood Obesity and Promote Healthy Life-styles: CoSIE Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04915092
- Acronym / sponsor ID
- CoSIE / ID:360 - CoSIE app
- Conditions
- Childhood Obesity
- Keywords
- mhealth, app, obesity, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Childhood obesity is a highly prevalent condition and together with the behaviours associated with it, such as improper diet and physical inactivity, it generates a high burden of disease in adulthood.
In recent years, it is increasing the use of mobile devices in support of health prevention and promotion strategies. In a primary care setting these new technologies offer the opportunity to open a two-way communication channel between parents and institutions and can help by adapting the intervention and framing the message according to the needs of each family.
Since 2010, the Reggio Emilia AUSL has started a research and interventions program aimed at preventing childhood obesity. The program has adopted a multilevel and multi-setting strategy for primary prevention (BMInforma Program).
Since 2017, together with the University of Bologna and the regional company Lepida2000, the Local Health Authority is part of the Co-creation of Service Innovation in Europe project (CoSIE Project), a project funded by the European Union with a Horizon 2020 call coordinated by the University of Turku, Finland. The CoSIE project promotes the co-creation of public services through the involvement of citizens and other interested parties in the definition of objectives and delivery methods.
The project is divided into nine pilot projects and the Italian pilot project, carried out in the province of Reggio Emilia, is part of the AUSL program for the prevention of childhood obesity. The aim of the pilot project is to create a network between the services involved in the prevention and treatment of obesity and, at the same time, it aims to create an app that can help promote a healthy lifestyle. The app was designed and created with a co-creation process.
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. Furthermore,an aim of the study is to evaluate 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. The recruitment is done by some members of the CoSIE project Consulting Committee:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Families in the intervention arm will receive the app
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: CoSIE appThe 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 | No intervention | –Every months during the first year of study a newsletter is sent only to the members of the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- parents of children aged 3 to 11 presneting for a new well child visit or for a sport medicin visit or presenting for a childhood obesity visit at the AUSL Reggio Emilia clinics, including family pediatricians clinics.
Key exclusion criteria (7 listed)
- Families resident outside the Province of Reggio Emilia
- Parents with no comprehension of the Italian language
- Children inside a program for obesity cure or prevention. The program are:
- Children with severe obesity previously diagnosed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoSIE appThe 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. | Device | Intervention group |
Primary outcome
Change in consumption of sugar - sweetened beverages and juice, first year
Time frame: 12 months
Endpoint: number per week Outcome: Delta 12m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Change in consumption of sugar - sweetened beverages and juice, second year
Time frame: 24 months
Endpoint: number per week Outcome: Delta 24m - baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Change in consumption of hypercaloric foods like fried food, salty snacks and sweet snacks/candies, first year
Time frame: 12 months
Endpoint: number per week Outcome: Delta 12m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Change of consumption of hypercaloric foods like fried food, salty snacks and sweet snacks/candies, second year
Time frame: 24 months
Endpoint: number per week Outcome: Delta 24m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Change in screen time spent by children, first year
Time frame: 12 months
Endpoint: Minutes of screen time per day Outcome: Delta 12m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Change in screen time spent by children, second year
Time frame: 24 months
Endpoint: Minutes of screen time per day Outcome: Delta 24m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
4 secondary outcomes
BMI centile of children after the first year
Time frame: 12 months
BMI centile of children after the second year
Time frame: 24 months
Acceptability
Time frame: after at 12 months of app utilization
Usability
Time frame: after at 12 months of app utilization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Background: PubMed 32357123Giorgi Rossi P, Ferrari F, Amarri S, Bassi A, Bonvicini L, Dall'Aglio L, Della Giustina C, Fabbri A, Ferrari AM, Ferrari E, Fontana M, Foracchia M, Gallelli T, Ganugi G, Ilari B, Lo Scocco S, Maestri G, Moretti V, Panza C, Pinotti M, Prandini R, Storani S, Street ME, Tamelli M, Trowbridge H, Venturelli F, Volta A, Davoli AM; Childhood Obesity Prevention Working Group. Describing the Process and Tools Adopted to Cocreate a Smartphone App for Obesity Prevention in Childhood: Mixed Method Study. JMIR Mhealth Uhealth. 2020 Jun 8;8(6):e16165. doi: 10.2196/16165.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Giorgi Rossi, phd principal investigator
Azienda USL-IRCCS Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoSIE app in people with Childhood Obesity, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in consumption of sugar - sweetened beverages and juice, first year (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04915092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.