Digital Cardiovascular Health Promotion Among School-going Adolescents in Nepal (HRIDAYA)

October 30, 2024 updated by: Dayana Shakya, Kathmandu Medical College and Teaching Hospital

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

345

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Bagmati
      • Kathmandu, Bagmati, Nepal, 44600
        • Kathmandu Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adolescents studying in grades 8-10 in public and private schools in JD-HDSS.

Exclusion Criteria:

  • Adolescents absent during data collection period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital intervention arm
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.
Other: 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: No digital intervention arm
The control group adolescents will receive the same serious game 'Happy Heart' but after the study period is over
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attitude score
Time Frame: 2 months

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'.
2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Practice score
Time Frame: 2 months

The practice of the adolescents will be measured using the practice part of the 'Knowledge, attitude and practice of cardiovascular disease among school-going adolescents' questionnaire before and after the serious game is administered. The practice will be scored based on the American Heart Association guidelines. These included if the adolescents ate five servings of fruits and vegetables, practiced 60 minutes of physical activity daily and did not smoke or drink.

The total score obtained by the adolescents in practice will be converted into percentage. So the minimum score is 0% and maximum score is 100%. Higher the score better will be the practice.

Another secondary outcome is the change in practice score of adolescents before and after playing the serious game 'Happy Heart'.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kathmandu Medical College and Teaching Hospital

Collaborators

University of Skövde

Investigators

  • Study Chair: Alexandra Krettek, PhD, University of Skövde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2023

Primary Completion (Actual)

September 10, 2023

Study Completion (Actual)

September 10, 2023

Study Registration Dates

First Submitted

October 27, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 660/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data will be made available after the trial results have been published.

IPD Sharing Time Frame

IPD will be available after the publication of the study.

IPD Sharing Access Criteria

Data access requests will be reviewed by external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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