Mobile ApplicationsNCT04633070
Systematic Review of Health App Gamification for Lifestyle Intervention Adherence
An observational study of Mobile Applications and Diet, Healthy, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobile Applications, Diet, Healthy, Behavior, Health
- What is being tested?
- Gamification
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2020to Nov 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adults (>=18 years), regardless of health status.
Who may be able to join
- 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
Show all 9Show fewer
- Duration >= 2-months
- Assessment of the exposure of gamification used in a health behaviour application
- Ascertainment of viable outcome data by level of exposure
Who cannot join
- Lack of an adequate comparator
- Non-health behaviour application
- Ecological, cross-sectional, or retrospective observational studies
- Intervention studies
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5C 2T2
About this study
Official title: Use of Gamification in Health Apps for Lifestyle Intervention: A Systematic Review
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.
Read the 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.
- Conditions
- Mobile Applications, Diet, Healthy, Behavior, Health
- Being tested
- Gamification
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GamificationBehavioural
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the intervention
Percentage change
Measured: At least 2 months
Secondary outcomes (14)
Participant app engagement
Adherence to using the app based on number of using days using the app compared to intended number of days of app usage
Measured: At least 2 months
Health outcome - body weight
Weight change
Measured: At least 2 months
Health outcome - BMI
BMI change
Measured: At least 2 months
Health outcome - body fat
Body fat change
Measured: At least 2 months
Health outcome - waist circumference
Waist circumference
Measured: At least 2 months
Health outcome - HbA1c
HbA1c change
Measured: At least 2 months
Health outcome - fasting plasma glucose (FPG)
FPG change
Measured: At least 2 months
Health outcome - LDL-cholesterol (LDL-C)
LDL-C change
Measured: At least 2 months
Health outcome - non-HDL-cholesterol (non-HDL-C)
Non-HDL-C change
Measured: At least 2 months
Health outcome - apoB
ApoB change
Measured: At least 2 months
Health outcome - HDL-cholesterol (HDL-C)
HDL-C change
Measured: At least 2 months
Health outcome - triglycerides
Triglycerides change
Measured: At least 2 months
Health outcome - systolic blood pressure (SBP)
SBP change
Measured: At least 2 months
Health outcome - diastolic blood pressure (DBP)
DBP change
Measured: At least 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start5 Nov 2020
- Primary completionNov 2021 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Mobile ApplicationsStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Sievenpiper, University of Toronto
- Investigators
- John L Sievenpiper, MD,PhD,FRCPC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633070
- Sponsor's protocol ID
- CCS-Health Apps 2020
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30819694El-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.
PubMed 27777216GBD 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.
PubMed 30496105Johnson 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.
PubMed 30135818Cumpston 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.
PubMed 31643080Lally 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.
PubMed 32877425Marin-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.
PubMed 30916655Moher 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.
PubMed 25554246Patel 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.
PubMed 31498375Statistics 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.
PubMed 31353783Nishi 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.
PubMed 39764571
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Gamification in Health Apps for Lifestyle Intervention: A Systematic Review
- ClinicalTrials.gov ID
- NCT04633070
- Acronym / sponsor ID
- CCS-Health Apps 2020
- Conditions
- Mobile Applications, Diet, Healthy, Behavior, Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 18 Nov 2020 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults (>=18 years), regardless of health status.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- Lack of an adequate comparator
- Non-health behaviour application
- Ecological, cross-sectional, or retrospective observational studies
- Intervention studies
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 |
|---|---|---|
| GamificationGamification (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). | Behavioural | – |
Primary outcome
Adherence to the intervention
Time frame: At least 2 months
Percentage change
14 secondary outcomes
Participant app engagement
Time frame: At least 2 months
Health outcome - body weight
Time frame: At least 2 months
Health outcome - BMI
Time frame: At least 2 months
Health outcome - body fat
Time frame: At least 2 months
Health outcome - waist circumference
Time frame: At least 2 months
Health outcome - HbA1c
Time frame: At least 2 months
Health outcome - fasting plasma glucose (FPG)
Time frame: At least 2 months
Health outcome - LDL-cholesterol (LDL-C)
Time frame: At least 2 months
Health outcome - non-HDL-cholesterol (non-HDL-C)
Time frame: At least 2 months
Health outcome - apoB
Time frame: At least 2 months
Health outcome - HDL-cholesterol (HDL-C)
Time frame: At least 2 months
Health outcome - triglycerides
Time frame: At least 2 months
Health outcome - systolic blood pressure (SBP)
Time frame: At least 2 months
Health outcome - diastolic blood pressure (DBP)
Time frame: At least 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Background: PubMed 30819694Alam 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.
- Background: PubMed 27777216El-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.
- Background: PubMed 30496105GBD 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.
- Background: PubMed 30135818Johnson 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.
- Background: PubMed 31643080Cumpston 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.
- BackgroundLally 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: PubMed 32877425Litvin 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.
- Background: PubMed 30916655Marin-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.
- Background: PubMed 25554246Moher 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.
- Background: PubMed 31498375Patel 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.
- BackgroundStatistics 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: PubMed 31353783Villinger 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.
- Individual participant dataSharing planned: No
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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.
John L Sievenpiper, MD,PhD,FRCPC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mobile Applications and Diet, Healthy, run by University of Toronto at 1 site in Canada.
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 9 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Nov 2020. 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 Canada. 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?
Results are not available in the source record.
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?
Adherence to the intervention (time frame: At least 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 NCT04633070, which also lists 13 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 19 Nov 2020.