Heart DiseaseHRIDAYANCT06668675
Digital Cardiovascular Health Promotion Among School-going Adolescents in Nepal
A study testing A serious game known as the 'Happy Heart' will be used as the intervention. in people with Heart Disease, run by Kathmandu Medical College and Teaching Hospital at 1 site in Nepal.
Trial summary
The goal of this HRIDAYA project is to see if a digital mobile game can improve knowledge about heart disease among school-going adolescents. The researchers will divide adolescents of public and private schools into two groups. Each group will contain adolescents from both the school types. Read more about this study
- Who is it for?
- Ages 13 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Disease
- What is being tested?
- A serious game known as the 'Happy Heart' will be used as the intervention.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteNepal
- Study dates
- 2 Jul 2023to 10 Sep 2023
- 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 13 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents studying in grades 8-10 in public and private schools in JD-HDSS.
Who cannot join
- Adolescents absent during data collection period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Intervention for School-going Adolescents: A Serious Games Approach for Cardiovascular Health Promotion in Nepal
The goal of this HRIDAYA project is to see if a digital mobile game can improve knowledge about heart disease among school-going adolescents. The researchers will divide adolescents of public and private schools into two groups. Each group will contain adolescents from both the school types. Knowledge, attitude and practice (KAP) of adolescents will be tested before intervention. One group will receive a mobile game and the other will not receive the game.
After two weeks of game play, the KAP of the adolescents will be tested again. The changes in KAP before and after playing the game in the two groups will be compared.
Read more
The participants will need to:
- Give pretest of KAP regarding CVD
- Download the game in their mobile devices.
- Install the game
- Play the game for 2 weeks
- Give post test of KAP regarding CVD
Read the detailed description
With the rise in non-communicable diseases (NCDs), cardiovascular disease (CVD) prevalence is increasing in Nepal. CVD risk factors (smoking, harmful use of alcohol, insufficient intake of fruits and vegetables, obesity, hypertension, diabetes and dyslipidemia) are common among adolescents. Despite high prevalence, the knowledge, attitude and practice regarding CVD among adolescents is poor. Since CVDs often begin with modifiable risk behaviors established during adolescence which manifest later, it becomes utmost important to target this population. To tackle this growing problem, a possible way to educate the children on heart-health at the community level is through schools.
The overall aim of this HRIDAYA project is to develop a cardiovascular health education and pilot it among school-going adolescents in Nepal to improve their cardiovascular health awareness.
This HRIDAYA project is a school based parallel trial with digital health promotion intervention aimed at adolescents of grades 8-10 in the public and private schools of Jhaukhel and Duwakot Health Demographic Surveillance Site (JD-HDSS). The JD-HDSS consists of two wards Jhaukhel and Duwakot of Bhaktapur district, 13 kms away from Kathmandu, the capital of Nepal.
A baseline study was carried out to identify knowledge gaps regarding cardiovascular disease (CVDs) among adolescents. These gaps defined the learning goals of the game. Then a paper game prototype was developed in collaboration with the School of Informatics, University of Skövde, Sweden and tested among 10 adolescents. The knowledge gaps combined with the visual recognition and preferences from the paper game prototype testing were mapped into the serious game mechanics resulting in a digital serious game called 'Happy Heart'.
For the intervention, adolescents studying in grades 8-10 from one public and two private schools will be selected purposively for each of the intervention and control arm of the study. Pre-intervention testing of the knowledge, attitude and practice (KAP) will be done before the intervention. The adolescents in the intervention arm will receive a link to download the game in their mobile devices. They will play the game for 2 weeks. A post intervention test will again be done regarding the KAP for CVDs.
The data will be entered and analyzed in SPSS version 28. The change in knowledge (primary outcome), attitude and practice (secondary outcome) in the intervention and control group will be identified using the difference in difference analysis.
- Conditions
- Heart Disease
- Being tested
- A serious game known as the 'Happy Heart' will be used as the intervention.
- Keywords
- Digital cardiovascular health promotion, Nepal, School-going adolescents, Mobile games, Serious games
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A serious game known as the 'Happy Heart' will be used as the intervention.Other
The serious game known as 'Happy Heart' is a mobile game used for educational purpose in addition to entertainment. It focuses on healthy habits for the heart and is aimed at improving knowledge on diet and physical activity among school-going adolescents.
The game is developed in collaboration with the game development team from the School of Informatics, University of Skövde and the health team from Kathmandu Medical College, Nepal.
| Study group | Role | What they receive |
|---|---|---|
| Digital intervention arm | Experimental | This intervention arm will receive the serious game known as 'Happy Heart'. The game will be installed in their mobile devices through a link. The adolescents in this arm will play the game on their mobiles for 2 weeks. Receives: Other: A serious game known as the 'Happy Heart' will be used as the intervention. |
| No digital intervention arm | Other | The control group adolescents will receive the same serious game 'Happy Heart' but after the study period is over Receives: Other: A serious game known as the 'Happy Heart' will be used as the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge score
The knowledge of the adolescents will be measured using the knowledge part of the 'Knowledge, attitude and practice of cardiovascular disease among school-going adolescents' questionnaire before and after the serious game is administered. The total knowledge score obtained by the adolescents will be converted into percentage. So the minimum score is 0% and maximum score is 100%. Higher the percent score, better will be the knowledge.
The primary outcome is the change in knowledge score of adolescents before and after playing the serious game 'Happy Heart'.
Measured: 2 months
Secondary outcomes (1)
Attitude score
The attitude of the adolescents will be measured using the 5 point Likert scale in the attitude part of the 'Knowledge, attitude and practice of cardiovascular disease among school-going adolescents' questionnaire before and after the serious game is administered. The total score obtained by the adolescents in attitude will be converted into percentage. So the minimum score is 0% and maximum score is 100%. Higher the percent score, better will be the attitude.
So, the secondary outcome is the change in attitude score of adolescents before and after playing the serious game 'Happy Heart'.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start2 Jul 2023
- Primary completion10 Sep 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathmandu Medical College and Teaching Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Skövde
- Responsible party
- Principal investigator, Dayana Shakya, Kathmandu Medical College and Teaching Hospital
- Investigators
- Alexandra Krettek, PhD, Study chair, University of Skövde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668675
- Sponsor's protocol ID
- 660/2021
- Acronym
- HRIDAYA
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available after the trial results have been published.
Publications
Aryal UR, Vaidya A, Shakya-Vaidya S, Petzold M, Krettek A. Establishing a health demographic surveillance site in Bhaktapur district, Nepal: initial experiences and findings. BMC Res Notes. 2012 Sep 5;5:489. doi: 10.1186/1756-0500-5-489.
PubMed 22950751Nepal M, Pokharel B, Nepal P. Awareness and attitude regarding cardiovascular diseases among the adolescents studying in grade 12 in Makawanpur Multiple Campus in Nepal. Int J Heal Sci Res. 2021;11(5):261-8.
Yadav K, Wagle R. Knowledge and attitude regarding major risk factors of cardiovascular diseases among 15-19 year old students of Kathmandu District. Heal Prospect. 2012;11:7-10.
Neupane T, Pandey AR, Bista B, Chalise B. Correlates of bullying victimization among school adolescents in Nepal: Findings from 2015 Global School-Based Student Health Survey Nepal. PLoS One. 2020 Aug 19;15(8):e0237406. doi: 10.1371/journal.pone.0237406. eCollection 2020.
PubMed 32813689Khanal MK, Mansur Ahmed MSA, Moniruzzaman M, Banik PC, Dhungana RR, Bhandari P, Devkota S, Shayami A. Prevalence and clustering of cardiovascular disease risk factors in rural Nepalese population aged 40-80 years. BMC Public Health. 2018 May 31;18(1):677. doi: 10.1186/s12889-018-5600-9.
PubMed 29855293Pearson TA, Palaniappan LP, Artinian NT, Carnethon MR, Criqui MH, Daniels SR, Fonarow GC, Fortmann SP, Franklin BA, Galloway JM, Goff DC Jr, Heath GW, Frank AT, Kris-Etherton PM, Labarthe DR, Murabito JM, Sacco RL, Sasson C, Turner MB; American Heart Association Council on Epidemiology and Prevention. American Heart Association Guide for Improving Cardiovascular Health at the Community Level, 2013 update: a scientific statement for public health practitioners, healthcare providers, and health policy makers. Circulation. 2013 Apr 23;127(16):1730-53. doi: 10.1161/CIR.0b013e31828f8a94. Epub 2013 Mar 21. No abstract available.
PubMed 23519758Eckel RH, Jakicic JM, Ard JD, de Jesus JM, Houston Miller N, Hubbard VS, Lee IM, Lichtenstein AH, Loria CM, Millen BE, Nonas CA, Sacks FM, Smith SC Jr, Svetkey LP, Wadden TA, Yanovski SZ, Kendall KA, Morgan LC, Trisolini MG, Velasco G, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S76-99. doi: 10.1161/01.cir.0000437740.48606.d1. Epub 2013 Nov 12. No abstract available.
PubMed 24222015Lichtenstein AH, Appel LJ, Vadiveloo M, Hu FB, Kris-Etherton PM, Rebholz CM, Sacks FM, Thorndike AN, Van Horn L, Wylie-Rosett J. 2021 Dietary Guidance to Improve Cardiovascular Health: A Scientific Statement From the American Heart Association. Circulation. 2021 Dec 7;144(23):e472-e487. doi: 10.1161/CIR.0000000000001031. Epub 2021 Nov 2.
PubMed 34724806
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Intervention for School-going Adolescents: A Serious Games Approach for Cardiovascular Health Promotion in Nepal
- ClinicalTrials.gov ID
- NCT06668675
- Acronym / sponsor ID
- HRIDAYA / 660/2021
- Conditions
- Heart Disease
- Keywords
- Digital cardiovascular health promotion, Nepal, School-going adolescents, Mobile games, Serious games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Kathmandu Medical College and Teaching HospitalUniversity, hospital or other
- Collaborators
- University of Skövde
- Study start
- 2 Jul 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 31 Oct 2024 (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 goal of this HRIDAYA project is to see if a digital mobile game can improve knowledge about heart disease among school-going adolescents. The researchers will divide adolescents of public and private schools into two groups. Each group will contain adolescents from both the school types. Knowledge, attitude and practice (KAP) of adolescents will be tested before intervention. One group will receive a mobile game and the other will not receive the game.
After two weeks of game play, the KAP of the adolescents will be tested again. The changes in KAP before and after playing the game in the two groups will be compared.
The participants will need to:
- Give pretest of KAP regarding CVD
- Download the game in their mobile devices.
- Install the game
- Play the game for 2 weeks
- Give post test of KAP regarding CVD
Detailed description
With the rise in non-communicable diseases (NCDs), cardiovascular disease (CVD) prevalence is increasing in Nepal. CVD risk factors (smoking, harmful use of alcohol, insufficient intake of fruits and vegetables, obesity, hypertension, diabetes and dyslipidemia) are common among adolescents. Despite high prevalence, the knowledge, attitude and practice regarding CVD among adolescents is poor. Since CVDs often begin with modifiable risk behaviors established during adolescence which manifest later, it becomes utmost important to target this population. To tackle this growing problem, a possible way to educate the children on heart-health at the community level is through schools.
The overall aim of this HRIDAYA project is to develop a cardiovascular health education and pilot it among school-going adolescents in Nepal to improve their cardiovascular health awareness.
This HRIDAYA project is a school based parallel trial with digital health promotion intervention aimed at adolescents of grades 8-10 in the public and private schools of Jhaukhel and Duwakot Health Demographic Surveillance Site (JD-HDSS). The JD-HDSS consists of two wards Jhaukhel and Duwakot of Bhaktapur district, 13 kms away from Kathmandu, the capital of Nepal.
A baseline study was carried out to identify knowledge gaps regarding cardiovascular disease (CVDs) among adolescents. These gaps defined the learning goals of the game. Then a paper game prototype was developed in collaboration with the School of Informatics, University of Skövde, Sweden and tested among 10 adolescents. The knowledge gaps combined with the visual recognition and preferences from the paper game prototype testing were mapped into the serious game mechanics resulting in a digital serious game called 'Happy Heart'.
For the intervention, adolescents studying in grades 8-10 from one public and two private schools will be selected purposively for each of the intervention and control arm of the study. Pre-intervention testing of the knowledge, attitude and practice (KAP) will be done before the intervention. The adolescents in the intervention arm will receive a link to download the game in their mobile devices. They will play the game for 2 weeks. A post intervention test will again be done regarding the KAP for CVDs.
The data will be entered and analyzed in SPSS version 28. The change in knowledge (primary outcome), attitude and practice (secondary outcome) in the intervention and control group will be identified using the difference in difference analysis.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital intervention arm | Experimental | Other: A serious game known as the 'Happy Heart' will be used as the intervention.This intervention arm will receive the serious game known as 'Happy Heart'. The game will be installed in their mobile devices through a link. The adolescents in this arm will play the game on their mobiles for 2 weeks. |
| No digital intervention arm | Other | Other: A serious game known as the 'Happy Heart' will be used as the intervention.The control group adolescents will receive the same serious game 'Happy Heart' but after the study period is over |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adolescents studying in grades 8-10 in public and private schools in JD-HDSS.
Key exclusion criteria (1 listed)
- Adolescents absent during data collection period
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 |
|---|---|---|
| A serious game known as the 'Happy Heart' will be used as the intervention.The serious game known as 'Happy Heart' is a mobile game used for educational purpose in addition to entertainment. It focuses on healthy habits for the heart and is aimed at improving knowledge on diet and physical activity among school-going adolescents. The game is developed in collaboration with the game development team from the School of Informatics, University of Skövde and the health team from Kathmandu Medical College, Nepal. | Other | Digital intervention arm, No digital intervention arm |
Primary outcome
Knowledge score
Time frame: 2 months
The knowledge of the adolescents will be measured using the knowledge part of the 'Knowledge, attitude and practice of cardiovascular disease among school-going adolescents' questionnaire before and after the serious game is administered. The total knowledge score obtained by the adolescents will be converted into percentage. So the minimum score is 0% and maximum score is 100%. Higher the percent score, better will be the knowledge. The primary outcome is the change in knowledge score of adolescents before and after playing the serious game 'Happy Heart'.
1 secondary outcome
Attitude score
Time frame: 2 months
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 31 Oct 2024.
- Background: PubMed 22950751Aryal UR, Vaidya A, Shakya-Vaidya S, Petzold M, Krettek A. Establishing a health demographic surveillance site in Bhaktapur district, Nepal: initial experiences and findings. BMC Res Notes. 2012 Sep 5;5:489. doi: 10.1186/1756-0500-5-489.
- BackgroundNepal M, Pokharel B, Nepal P. Awareness and attitude regarding cardiovascular diseases among the adolescents studying in grade 12 in Makawanpur Multiple Campus in Nepal. Int J Heal Sci Res. 2021;11(5):261-8.
- BackgroundYadav K, Wagle R. Knowledge and attitude regarding major risk factors of cardiovascular diseases among 15-19 year old students of Kathmandu District. Heal Prospect. 2012;11:7-10.
- Background: PubMed 32813689Neupane T, Pandey AR, Bista B, Chalise B. Correlates of bullying victimization among school adolescents in Nepal: Findings from 2015 Global School-Based Student Health Survey Nepal. PLoS One. 2020 Aug 19;15(8):e0237406. doi: 10.1371/journal.pone.0237406. eCollection 2020.
- Background: PubMed 29855293Khanal MK, Mansur Ahmed MSA, Moniruzzaman M, Banik PC, Dhungana RR, Bhandari P, Devkota S, Shayami A. Prevalence and clustering of cardiovascular disease risk factors in rural Nepalese population aged 40-80 years. BMC Public Health. 2018 May 31;18(1):677. doi: 10.1186/s12889-018-5600-9.
- Background: PubMed 23519758Pearson TA, Palaniappan LP, Artinian NT, Carnethon MR, Criqui MH, Daniels SR, Fonarow GC, Fortmann SP, Franklin BA, Galloway JM, Goff DC Jr, Heath GW, Frank AT, Kris-Etherton PM, Labarthe DR, Murabito JM, Sacco RL, Sasson C, Turner MB; American Heart Association Council on Epidemiology and Prevention. American Heart Association Guide for Improving Cardiovascular Health at the Community Level, 2013 update: a scientific statement for public health practitioners, healthcare providers, and health policy makers. Circulation. 2013 Apr 23;127(16):1730-53. doi: 10.1161/CIR.0b013e31828f8a94. Epub 2013 Mar 21. No abstract available.
- Background: PubMed 24222015Eckel RH, Jakicic JM, Ard JD, de Jesus JM, Houston Miller N, Hubbard VS, Lee IM, Lichtenstein AH, Loria CM, Millen BE, Nonas CA, Sacks FM, Smith SC Jr, Svetkey LP, Wadden TA, Yanovski SZ, Kendall KA, Morgan LC, Trisolini MG, Velasco G, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S76-99. doi: 10.1161/01.cir.0000437740.48606.d1. Epub 2013 Nov 12. No abstract available.
- Background: PubMed 34724806Lichtenstein AH, Appel LJ, Vadiveloo M, Hu FB, Kris-Etherton PM, Rebholz CM, Sacks FM, Thorndike AN, Van Horn L, Wylie-Rosett J. 2021 Dietary Guidance to Improve Cardiovascular Health: A Scientific Statement From the American Heart Association. Circulation. 2021 Dec 7;144(23):e472-e487. doi: 10.1161/CIR.0000000000001031. Epub 2021 Nov 2.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available after the trial results have been published.
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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.
Alexandra Krettek, PhD study chair
University of Skövde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A serious game known as the 'Happy Heart' will be used as the intervention. in people with Heart Disease, run by Kathmandu Medical College and Teaching Hospital at 1 site in Nepal.
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 31 Oct 2024. 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 Nepal. 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?
Knowledge score (time frame: 2 months). 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 NCT06668675, which also lists 8 linked publications.
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 31 Oct 2024.