NCT06668675

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 27, 2024

Last Update Submit

October 30, 2024

Conditions

Keywords

Digital cardiovascular health promotionNepalSchool-going adolescentsMobile gamesSerious games

Outcome Measures

Primary Outcomes (1)

  • 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'.

    2 months

Secondary Outcomes (1)

  • Attitude score

    2 months

Other Outcomes (1)

  • Practice score

    2 months

Study Arms (2)

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.

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

Other: A serious game known as the 'Happy Heart' will be used as the intervention.

Interventions

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.

Digital intervention armNo digital intervention arm

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Adolescents absent during data collection period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kathmandu Medical College

Kathmandu, Bagmati, 44600, Nepal

Location

Related Publications (8)

  • 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.

    PMID: 22950751BACKGROUND
  • Nepal 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Aryal KK, Bista B, Khadka BB, Pandey AR, Mehta R, Jha BK, et al. Global School Based Student Health Survey Nepal-2015. Global School Based Student Health Survey Nepal. Nepal Health Research Council; 2015.

    BACKGROUND
  • Khanal 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.

    PMID: 29855293BACKGROUND
  • Pearson 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.

    PMID: 23519758BACKGROUND
  • Eckel 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.

    PMID: 24222015BACKGROUND
  • Lichtenstein 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.

    PMID: 34724806BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Alexandra Krettek, PhD

    University of Skövde

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 27, 2024

First Posted

October 31, 2024

Study Start

July 2, 2023

Primary Completion

September 10, 2023

Study Completion

September 10, 2023

Last Updated

October 31, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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

Time Frame
IPD will be available after the publication of the study.
Access Criteria
Data access requests will be reviewed by external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations