Pediatric NutritionPhase 1NCT04082195
Impact of A Mobile Game on Pediatric Nutrition and Physical Activity
A Phase 1 study testing Fooya mobile game and Uno board game in people with Pediatric Nutrition, run by Center for Communication and Change India.
Trial summary
Overweight and obesity in children is on the rise globally and is rapidly growing in urban India. Studies have revealed that obesity is on the rise among children in India with many of them suffering from the problem even before they reach adolescence. Read more about this study
- Who is it for?
- Ages 10 to 11 years
- Conditions the study is for
- Pediatric Nutrition
- What is being tested?
- Fooya mobile game and Uno board game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 14 Jun 2016to 9 Dec 2016
- Phase
- Phase 1
- 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 10 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- class (grade) 5 students
Who cannot join
- none
About this study
Official title: Impact of Digital Health Education Intervention - Fooya on Health Awareness Around Eating Right and Physical Activity of School Going Children in Chennai
Overweight and obesity in children is on the rise globally and is rapidly growing in urban India. Studies have revealed that obesity is on the rise among children in India with many of them suffering from the problem even before they reach adolescence.
As many as 30 million Indians are overweight, and obesity continues to rise. The National Family Health Survey (NFHS) found that 20% of school children are overweight. NFHS is a large-scale, multi-round survey conducted in a representative sample of households throughout India. The findings from the survey indicate that the prevalence of obesity is increasing in India along with the epidemic proportions worldwide especially in developed countries.
Read more
Overweight or obesity is the leading cause of type 2 diabetes, gestational diabetes, hypertension, osteoarthritis, various types of cancers in women like breast cancer and uterine cancer, menstrual disorder and infertility and many more diseases.
To decrease prevalence you have to decrease incidence. More and more young people are at risk of developing diseases like diabetes and if the number of children living with these diseases has to come down, focus has to be on addressing the risk factors and moving the population to a healthier lifestyle through health education/ communication and motivation. To design appropriate interventions for behaviour formation and change, we need to learn more about the underlying factors affecting these unhealthy behaviours.
This study was conducted by the Center for Communication and Change - India, in partnership with the Johns Hopkins Bloomberg School of Public Health Center for Communication Programs, and FriendsLearn (California).
Study Purpose
The specific aim of this research study is to assess the awareness levels among urban, Indian children, with respect to diet and lifestyle behaviours, while also evaluating the influence of a digital health education intervention - fooya!™ among school-age children in India. Specifically, the study objectives will be:
- Quantify the effectiveness of a digital health education intervention- fooya (an application) on health awareness around eating right and physical activity
- Find out the current diet and physical activity among urban, children in India and the factors that affect them
- Assess the extent of their awareness about eating right and physical activity
- Conditions
- Pediatric Nutrition
- Being tested
- Fooya mobile game, Uno board game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fooya mobile gameOther
An application that incorporates the science and technology of immersive gaming, neuropsychology and cognitive behavior therapy in a mobile health game to target early childhood nutrition literacy and health promotion in a fun and exciting way.
Uno board gameOther
A popular board game which is not a mobile app.
| Study group | Role | What they receive |
|---|---|---|
| Fooya mobile game | Experimental | An arm that receives a mobile-app-based treatment. Receives: Other: Fooya mobile game |
| Uno board game | Active comparator | An arm that receives a non mobile-app-based treatment. Receives: Other: Uno board game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actual food choice
The children were offered a selection of food items to choose from, and the actual selection were documented.
Measured: Immediately after the intervention
Secondary outcomes (3)
Subjective food choice
The children completed surveys to indicate their preferred food items among a list
Measured: Immediately after the intervention
Knowledge of healthy eating
The children completed surveys to indicate their knowledge of healthy eating practice
Measured: Immediately after the intervention
Knowledge of physical activity
The children completed surveys to indicate their knowledge of physical activity
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start14 Jun 2016
- Primary completion9 Dec 2016
- Study completion9 Dec 2016
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 Pediatric NutritionStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Communication and Change India
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Carnegie Mellon University, Hofstra University, FriendsLearn Inc., The Mithra Trust, Mind in Motion, Seethapathy Clinic & Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082195
- Sponsor's protocol ID
- IRB00006230
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kato-Lin YC, Kumar UB, Sri Prakash B, Prakash B, Varadan V, Agnihotri S, Subramanyam N, Krishnatray P, Padman R. Impact of Pediatric Mobile Game Play on Healthy Eating Behavior: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Nov 18;8(11):e15717. doi: 10.2196/15717.
PubMed 33206054
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Digital Health Education Intervention - Fooya on Health Awareness Around Eating Right and Physical Activity of School Going Children in Chennai
- ClinicalTrials.gov ID
- NCT04082195
- Acronym / sponsor ID
- IRB00006230
- Conditions
- Pediatric Nutrition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Center for Communication and Change IndiaUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Carnegie Mellon University, Hofstra University, FriendsLearn Inc., The Mithra Trust, Mind in Motion, Seethapathy Clinic & Hospital
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 9 Sep 2019 (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.
Overweight and obesity in children is on the rise globally and is rapidly growing in urban India. Studies have revealed that obesity is on the rise among children in India with many of them suffering from the problem even before they reach adolescence.
As many as 30 million Indians are overweight, and obesity continues to rise. The National Family Health Survey (NFHS) found that 20% of school children are overweight. NFHS is a large-scale, multi-round survey conducted in a representative sample of households throughout India. The findings from the survey indicate that the prevalence of obesity is increasing in India along with the epidemic proportions worldwide especially in developed countries.
Overweight or obesity is the leading cause of type 2 diabetes, gestational diabetes, hypertension, osteoarthritis, various types of cancers in women like breast cancer and uterine cancer, menstrual disorder and infertility and many more diseases.
To decrease prevalence you have to decrease incidence. More and more young people are at risk of developing diseases like diabetes and if the number of children living with these diseases has to come down, focus has to be on addressing the risk factors and moving the population to a healthier lifestyle through health education/ communication and motivation. To design appropriate interventions for behaviour formation and change, we need to learn more about the underlying factors affecting these unhealthy behaviours.
This study was conducted by the Center for Communication and Change - India, in partnership with the Johns Hopkins Bloomberg School of Public Health Center for Communication Programs, and FriendsLearn (California).
Study Purpose
The specific aim of this research study is to assess the awareness levels among urban, Indian children, with respect to diet and lifestyle behaviours, while also evaluating the influence of a digital health education intervention - fooya!™ among school-age children in India. Specifically, the study objectives will be:
- Quantify the effectiveness of a digital health education intervention- fooya (an application) on health awareness around eating right and physical activity
- Find out the current diet and physical activity among urban, children in India and the factors that affect them
- Assess the extent of their awareness about eating right and physical activity
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fooya mobile game | Experimental | Other: Fooya mobile gameAn arm that receives a mobile-app-based treatment. |
| Uno board game | Active comparator | Other: Uno board gameAn arm that receives a non mobile-app-based treatment. |
Who may qualify
- Ages
- 10 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- class (grade) 5 students
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Fooya mobile gameAn application that incorporates the science and technology of immersive gaming, neuropsychology and cognitive behavior therapy in a mobile health game to target early childhood nutrition literacy and health promotion in a fun and exciting way. | Other | Fooya mobile game |
| Uno board gameA popular board game which is not a mobile app. | Other | Uno board game |
Primary outcome
Actual food choice
Time frame: Immediately after the intervention
The children were offered a selection of food items to choose from, and the actual selection were documented.
3 secondary outcomes
Subjective food choice
Time frame: Immediately after the intervention
Knowledge of healthy eating
Time frame: Immediately after the intervention
Knowledge of physical activity
Time frame: Immediately after the intervention
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 9 Sep 2019.
- Derived from this study: PubMed 33206054Kato-Lin YC, Kumar UB, Sri Prakash B, Prakash B, Varadan V, Agnihotri S, Subramanyam N, Krishnatray P, Padman R. Impact of Pediatric Mobile Game Play on Healthy Eating Behavior: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Nov 18;8(11):e15717. doi: 10.2196/15717.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fooya mobile game and Uno board game in people with Pediatric Nutrition, run by Center for Communication and Change India.
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 1 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 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Actual food choice (time frame: Immediately after the intervention). 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 NCT04082195, 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 9 Sep 2019.