- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04633070
Systematic Review of Health App Gamification for Lifestyle Intervention Adherence
Use of Gamification in Health Apps for Lifestyle Intervention: A Systematic Review
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Studies on health behaviours such as physical activity and smoking cessation (behaviour change) have indicated that gamification is an effective tool for engagement and behaviour change, especially when multiple different competitive elements are used including: a ranking system, badges and achievements, points, social media interaction, and leveling up. Gamification is the use of game elements in a non-game environment to invoke behaviour change. The majority of health-focused gamification investigations are currently conducted using web or mobile-based delivery platforms in adults focusing on physical activity. Access to these web and mobile based applications through smartphones, tablets and computers has grown rapidly. In 2016, 94% of Canadians had home internet access, with 88% reporting that they use a smartphone for personal use. Moreover, a recent survey in the US found that 73% of those with, or at risk of cardiovascular disease, have a smartphone and 43% use a health-related application to track progress towards a health goal. While research on mobile-based app use for modifying diet is promising, the effectiveness of using gamification in apps for sustaining dietary pattern adherence is unclear. An investigation and summary of the current types of gamification strategies that may be most effective is important to inform and aid future app development. The ultimate aim of this research investigation is to inform the development of the PortfolioDiet.app, a dietary pattern adherence application for reducing LDL-cholesterol in individuals at risk for cardiovascular disease.
Objective: To conduct a systematic review investigating the gamification strategies used in applications for long term behaviour change, with a specific focus on dietary pattern adherence in adults.
Design: A systematic review of the literature will be conducted according to the Cochrane Handbook for Systematic Reviews of Interventions and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).
Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (Clinical Trials; CENTRAL) will be searched using appropriate search terms supplemented by hand searches of references of included studies.
Study selection: The investigators will include prospective cohort studies and controlled trials. Studies will be included if they are >= 2-months in duration and assess the relation of different gamification strategies used in health behaviour applications with adherence to the health intervention, participant engagement with using the application, and/or the intended health outcome. There will be no language restrictions.
Data extraction: Two or more investigators will independently extract relevant data and assess risk of bias using the Cochrane Risk of Bias Tool. All disagreements will be resolved by consensus.
Outcomes: The primary outcome will be adherence to the intervention associated with use of the application, such as, but not limited to: physical activity, smoking cessation, increasing fruit and vegetable intake, improving healthy food index score. Secondary outcomes will include participant engagement with use of the application. This adherence to using the application may be determined based on number of using days using the application compared to intended number of days of application usage. Observation of a significant change in the intended health outcome, such as, blood glucose, HbA1c, blood lipids, weight change [BMI, body weight, waist circumference, will also be assessed.
Data Synthesis: A Microsoft Excel spreadsheet will be used to track the extractions and summarize the qualitative and quantitative data from each study.
Risk of Bias (Quality) Assessment: The risk of bias of each included study will be assessed using the Cochrane Handbook for Systematic Reviews of Interventions. This will be done in relation to evaluating the criteria for assessing risk as either low, high or uncertain risk of bias as identified in the Risk of Bias tool.
Knowledge translation plan: The results will be disseminated through interactive presentations at local, national and international scientific meetings and publication. As well as utilized in a publically available web-based application hosted on the Canadian Cardiovascular Society website.
Significance: Gamification has been identified as a promising tool for health promotion. While research directly comparing gamified interventions to non-gamified controls has found beneficial effects on physical activity, or more recently mental health, there is a lack of evidence on investigating gamification for dietary change. As poor health behaviours (i.e. unhealthy diet, smoking, sedentary behaviour) have been repeatedly identified as major contributors to disease burden in Canada and globally, interventions which can target and improve these behaviours over a long term are required. Furthermore, as the generations who have grown up with the internet and app technology begin to age they will seek engaging digital tools to improve health outcomes, and therefore the need for digital health interventions that are effective at improving and sustaining beneficial health behaviours will only continue to grow.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5C 2T2
- Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for controlled trials:
- Randomized and non-randomized controlled intervention studies in humans
- Gamification intervention
- Presence of an adequate comparator, such as standard of care or an application without gamification components
- Intervention duration >=2 months
- Viable outcome data
Inclusion Criteria for prospective cohort studies:
- Prospective cohort studies
- Duration >= 2-months
- Assessment of the exposure of gamification used in a health behaviour application
- Ascertainment of viable outcome data by level of exposure
Exclusion Criteria for controlled trials:
- Lack of an adequate comparator
- Non-health behaviour application
Exclusion Criteria for prospective cohort studies:
- Ecological, cross-sectional, or retrospective observational studies
- Intervention studies
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to the intervention
Time Frame: At least 2 months
|
Percentage change
|
At least 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant app engagement
Time Frame: At least 2 months
|
Adherence to using the app based on number of using days using the app compared to intended number of days of app usage
|
At least 2 months
|
Health outcome - body weight
Time Frame: At least 2 months
|
Weight change
|
At least 2 months
|
Health outcome - BMI
Time Frame: At least 2 months
|
BMI change
|
At least 2 months
|
Health outcome - body fat
Time Frame: At least 2 months
|
Body fat change
|
At least 2 months
|
Health outcome - waist circumference
Time Frame: At least 2 months
|
Waist circumference
|
At least 2 months
|
Health outcome - HbA1c
Time Frame: At least 2 months
|
HbA1c change
|
At least 2 months
|
Health outcome - fasting plasma glucose (FPG)
Time Frame: At least 2 months
|
FPG change
|
At least 2 months
|
Health outcome - LDL-cholesterol (LDL-C)
Time Frame: At least 2 months
|
LDL-C change
|
At least 2 months
|
Health outcome - non-HDL-cholesterol (non-HDL-C)
Time Frame: At least 2 months
|
Non-HDL-C change
|
At least 2 months
|
Health outcome - apoB
Time Frame: At least 2 months
|
ApoB change
|
At least 2 months
|
Health outcome - HDL-cholesterol (HDL-C)
Time Frame: At least 2 months
|
HDL-C change
|
At least 2 months
|
Health outcome - triglycerides
Time Frame: At least 2 months
|
Triglycerides change
|
At least 2 months
|
Health outcome - systolic blood pressure (SBP)
Time Frame: At least 2 months
|
SBP change
|
At least 2 months
|
Health outcome - diastolic blood pressure (DBP)
Time Frame: At least 2 months
|
DBP change
|
At least 2 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- GBD 2017 Risk Factor Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1923-1994. doi: 10.1016/S0140-6736(18)32225-6. Epub 2018 Nov 8. Erratum In: Lancet. 2019 Jan 12;393(10167):132. Lancet. 2019 Jun 22;393(10190):e44.
- Alam S, Lang JJ, Drucker AM, Gotay C, Kozloff N, Mate K, Patten SB, Orpana HM, Afshin A, Cahill LE. Assessment of the burden of diseases and injuries attributable to risk factors in Canada from 1990 to 2016: an analysis of the Global Burden of Disease Study. CMAJ Open. 2019 Feb 28;7(1):E140-E148. doi: 10.9778/cmajo.20180137. Print 2019 Jan-Mar.
- El-Hilly AA, Iqbal SS, Ahmed M, Sherwani Y, Muntasir M, Siddiqui S, Al-Fagih Z, Usmani O, Eisingerich AB. Game On? Smoking Cessation Through the Gamification of mHealth: A Longitudinal Qualitative Study. JMIR Serious Games. 2016 Oct 24;4(2):e18. doi: 10.2196/games.5678.
- Johnson D, Deterding S, Kuhn KA, Staneva A, Stoyanov S, Hides L. Gamification for health and wellbeing: A systematic review of the literature. Internet Interv. 2016 Nov 2;6:89-106. doi: 10.1016/j.invent.2016.10.002. eCollection 2016 Nov.
- Cumpston M, Li T, Page MJ, Chandler J, Welch VA, Higgins JP, Thomas J. Updated guidance for trusted systematic reviews: a new edition of the Cochrane Handbook for Systematic Reviews of Interventions. Cochrane Database Syst Rev. 2019 Oct 3;10:ED000142. doi: 10.1002/14651858.ED000142. No abstract available.
- Lally P, van Jaarsveld CHM, Potts HWW, Wardle J. How are habits formed: Modelling habit formation in the real world. Eur J Soc Psychology. 2010; 40:998-1009.
- Litvin S, Saunders R, Maier MA, Luttke S. Gamification as an approach to improve resilience and reduce attrition in mobile mental health interventions: A randomized controlled trial. PLoS One. 2020 Sep 2;15(9):e0237220. doi: 10.1371/journal.pone.0237220. eCollection 2020.
- Marin-Gomez FX, Garcia-Moreno Marchan R, Mayos-Fernandez A, Flores-Mateo G, Granado-Font E, Barrera Uriarte ML, Duch J, Rey-Renones C. Exploring Efficacy of a Serious Game (Tobbstop) for Smoking Cessation During Pregnancy: Randomized Controlled Trial. JMIR Serious Games. 2019 Mar 27;7(1):e12835. doi: 10.2196/12835. Erratum In: JMIR Serious Games. 2019 Jul 11;7(3):e14381.
- Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA; PRISMA-P Group. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015 Jan 1;4(1):1. doi: 10.1186/2046-4053-4-1.
- Patel MS, Small DS, Harrison JD, Fortunato MP, Oon AL, Rareshide CAL, Reh G, Szwartz G, Guszcza J, Steier D, Kalra P, Hilbert V. Effectiveness of Behaviorally Designed Gamification Interventions With Social Incentives for Increasing Physical Activity Among Overweight and Obese Adults Across the United States: The STEP UP Randomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1624-1632. doi: 10.1001/jamainternmed.2019.3505.
- Statistics Canada. Canadian Internet Use Survey. Last modified: 29 October 2019. Retrieved: 20 October 2020. Available from: https://www150.statcan.gc.ca/n1/dailyquotidien/191029/dq191029a-eng.htm
- Villinger K, Wahl DR, Boeing H, Schupp HT, Renner B. The effectiveness of app-based mobile interventions on nutrition behaviours and nutrition-related health outcomes: A systematic review and meta-analysis. Obes Rev. 2019 Oct;20(10):1465-1484. doi: 10.1111/obr.12903. Epub 2019 Jul 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CCS-Health Apps 2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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