NCT04633070

Brief Summary

Health behaviour applications (also referred to as "apps") have the potential to provide several advantages for motivating behaviour change for health and well-being. Finding ways to increase and sustain health promoting behaviour changes has been a challenge during health app development. Gamification, which is the use of game elements in a non-game situation, shows promise and has proven effective in many fields. However, key questions remain concerning how to use gamification in apps to modify health behaviour, especially to support adherence to dietary pattern recommendations. To investigate and summarize the current evidence, a systematic review of the totality of evidence from clinical trials and observational studies will be conducted to capture and distinguish the types of gamification strategies that may be most effective in improving and sustaining health promoting behaviours to inform future health behaviour app development.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

November 5, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

12 months

First QC Date

November 9, 2020

Last Update Submit

November 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adherence to the intervention

    Percentage change

    At least 2 months

Secondary Outcomes (14)

  • Participant app engagement

    At least 2 months

  • Health outcome - body weight

    At least 2 months

  • Health outcome - BMI

    At least 2 months

  • Health outcome - body fat

    At least 2 months

  • Health outcome - waist circumference

    At least 2 months

  • +9 more secondary outcomes

Interventions

GamificationBEHAVIORAL

Gamification (including, but not limited to a ranking system, badges and achievements, points, social media interaction, and leveling up) within mobile and web-based applications (also referred to as 'apps') for lifestyle modification (diet, physical activity, smoking cessation etc).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adults (\>=18 years), regardless of health status.

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Lack of an adequate comparator
  • Non-health behaviour application
  • Ecological, cross-sectional, or retrospective observational studies
  • Intervention studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (13)

  • 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.

    PMID: 30819694BACKGROUND
  • 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.

    PMID: 27777216BACKGROUND
  • 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.

    PMID: 30496105BACKGROUND
  • 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.

    PMID: 30135818BACKGROUND
  • 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(10):ED000142. doi: 10.1002/14651858.ED000142. No abstract available.

    PMID: 31643080BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32877425BACKGROUND
  • 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.

    PMID: 30916655BACKGROUND
  • 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.

    PMID: 25554246BACKGROUND
  • 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.

    PMID: 31498375BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 31353783BACKGROUND
  • Nishi SK, Kavanagh ME, Ramboanga K, Ayoub-Charette S, Modol S, Dias GM, Kendall CWC, Sievenpiper JL, Chiavaroli L. Effect of digital health applications with or without gamification on physical activity and cardiometabolic risk factors: a systematic review and meta-analysis of randomized controlled trials. EClinicalMedicine. 2024 Sep 25;76:102798. doi: 10.1016/j.eclinm.2024.102798. eCollection 2024 Oct.

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • John L Sievenpiper, MD,PhD,FRCPC

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 18, 2020

Study Start

November 5, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2022

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations