Clinical trial NCT06818071: Using Gamified Elements to Increase Daily Step Count in University Students in Taiwan A RCT
Official title: Application of Gamified Elements to Increase Daily Step Count in University Students in Taiwan A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Gamification
Daily Step Count
Keywords: Gamified Elements
Gamification
Daily Step Count
Phsyical Activity
Health Promotion
Behavioral Change
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized into four different groups: 1. Control, 2. Individual Gamified Elements Group (IGG), 3. Combined Gamified Elements Group (CGG), and 4. Explicit Gamification Group (EGG).
Primary purpose: PREVENTION

Brief summary: Background: Physical inactivity is a major factor in the onset of non-communicable diseases (NCDs) worldwide. Heart disease, Diabetes mellitus, and hypertensive diseases are among the top 10 leading causes of death in Taiwan in 2021. Although 81.6% of Taiwanese participants in a 2022 nationwide survey responded that they exercised regularly, the Health Promotion Administration stated that 50.3% of the population from 2017-2020 is overweight or obese, up from 32.7% in 1993-1996. The intention-behavior gap in habit formation is difficult to overcome for most, especially when self-motivation is the biggest factor. Gamification, the use of game elements in non-game settings, and game elements can be used to lower the bar necessary for individuals to develop healthier daily habits.

Aim: This study aims to investigate the effects of applying gamified elements on the daily lives of university students in Taiwan to increase their daily step count as compared to their baseline and the control group, along with changes in certain health indicators, overall physical activity, sleep behavior \& quality, and mental health, whether combining gamified elements is more effective than implementing gamified elements individually, and if implicit or explicit gamification is more effective.

Methods: 300 participants will be recruited and, after providing informed consent, randomized into four groups: (1) Control, (2) Individual Gamified Elements Group (IGG), (3) Combined Gamified Elements Group (CGG), and (4) Explicit Gamification Group (EGG). Control group participants will add the official LINE account, submit weekly summaries of their DSC and to complete the three questionnaires. IGG, CGG, and EGG participants will be asked to add the official LINE account, download Google Fit onto their smartphone, establish a baseline for the first seven days, then set a Daily Step Count Goal (DSG) of an increase of 25%, 33%, or 50% on Day 7 of the study. IGG and CGG participants will then engage in various interventions, including Nudging (Week Two), and gamified interventions, including Points, Badges, \& Leaderboards (PBLs) (Weeks Three \& Four), Social Aspects (Weeks Five and Six), and Personalized Avatar \& Progression via Explicit Gamification (Weeks Seven \& Eight). IGG participants will engage with the multiple forms of gamified elements separately throughout the experiment, while CGG participants will slowly combine gamified elements as the experiment progresses (i.e. Week 2 Nudging, Week 3 Nudging + Points, Week 4 Nudging + Points + Leaderboard, etc.). EGG Participants will play Pikmin Bloom, which includes various gamified elements, for the duration of the study (8 weeks). Participants will complete the questionnaire at three points: the beginning of the experiment (initial check-in), the end of the experiment (8 weeks), and at follow-up (twelve weeks). The primary aim will be to determine whether or not the implementation of gamified elements will lead to an increase in overall DSC from baseline to 8 and 12 weeks, along with a certain percentage of patient-days that self-set DSGs are met at 8 and 12 weeks, as compared to the control group. Secondary outcomes include: how increasing participants' DSC will affect their health indicators, physical activity, mental health, and sleep behavior \& quality, comparing the effectiveness of combined gamified elements vs. individual gamified elements in increasing participants' DSC, and if implicit or explicit gamification is more effective at increasing DSC.

Detailed description: The purpose of this study is to measure the effects of the application of gamified elements on the intervention participants' daily step count (DSC) as compared to their baseline and control group. Potential candidates for the study will provide informed consent after being informed of the study, answer the questionnaire (consisting of the International Physical Activity Questionnaire - Short Form (IPAQ-SF), Pittsburgh Sleep Quality Index -Chinese version (PSQI-C), Insomnia Severity Index - Chinese Version (ISI-C), and the 12-item Short Form Survey (SF-12)). Participants will also measure their Blood Pressure, Heart Rate, Body Mass Index (BMI), Waist-to-Hip Ratio (WHR), Body Fat Percentage, Muscle Mass, Bone Density, and Body Fluid Amount. Intervention participants will establish a baseline for the first seven days, then set a Daily Step Goal (DSG) of an increase of 25%, 33%, or 50%. IGG and CGG participants will then engage in various interventions, including Nudging (Week Two), and gamified interventions, including Points, Badges, \& Leaderboards (PBLs) (Weeks Three \& Four), Social Aspects (Weeks Five and Six), and Personalized Avatar \& Progression (Weeks Seven \& Eight). Points accumulated will be reset each week to give participants a fresh start. EGG participants will play Pikmin Bloom for the study duration. The primary aim will be to determine whether or not the implementation of gamified elements will lead to an increase in overall DSC from baseline to 8 and 12 weeks, along with a certain percentage of patient-days that self-set DSGs are met at 8 and 12 weeks, as compared to the control group. Secondary outcomes include: how increasing participants' DSC will affect their health indicators, physical activity, mental health, and sleep behavior \& quality, comparing the effectiveness of combined gamified elements vs. individual gamified elements in increasing participants' DSC, and if implicit or explicit gamification is more effective at increasing DSC.

Two previous studies conducted in the United States of America are the main basis for this study. The first study, "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", published in 2019 by Mitesh S. Patel et al, found that using gamified interventions - support, collaboration, and competition - "significantly increased physical activity compared with the control group during the 24-week intervention".

The second study, "Effect of Behaviorally Designed Gamification with Social Incentives on Lifestyle Modification Among Adults with Uncontrolled Diabetes - A Randomized Clinical Trial", published in 2021 by Mitesh S. Patel et al, found that gamified interventions "designed to enhance support or competition each significantly increased physical activity relative to controls during the 1-year intervention".

Potential risks in this study will be minimal and the risk/benefit ratio will be in favor of the participants. To reduce the potential of unexpected adverse events, the research team will assess the potential participants at the initial check-in to the best of their ability on their potential to complete the experiment. If participants are deemed unfit to complete the experiment (injury, unable to participate for 12 weeks, etc.), the research team will inform the participant and remove them from the study.

This study is based on studies conducted in the United States mentioned in Section 2.3 that have resulted in some significant results in certain vulnerable populations. The research team wanted to conduct a study in the similar vein but with alterations in regards to the overall concepts and population. The study population investigated in this study will be different but the hope of this research is that if there is significance in the application of gamified elements on the increase of DSC, then we will be able to conduct further studies in different populations, including vulnerable ones, to improve health and healthy behaviors.

This study will be conducted in compliance with the protocol approved by the Institutional Review Board, and according to Good Clinical Practice standards. No deviation from the protocol will be implemented without the prior review and approval of the IRB except where it may be necessary to eliminate an immediate hazard to a research subject. In such case, the deviation will be reported to the IRB as soon as possible.

300 participants from Taipei Medical University ages 18 to 35 enrolled, have access to a smartphone, and have a LINE account will be enrolled in the study. The researchers will use convenience sampling to enroll participants into the study.

The purpose of this study is the explore the potential effectiveness of the application of gamified elements to promote physical activity among university students in Taiwan.

Research objectives of this study are to:

1. Determine whether or not the implementation of gamified elements will lead to an increase in overall DSC from baseline to 8 and 12 weeks, along with a certain percentage of patient-days that self-set DSGs are met at 8 and 12 weeks, as compared to the control group.
2. Determine the potential effectiveness of increasing participants' DSC and its effects on health indicators, mental health, and sleep behavior and quality
3. comparing the effectiveness of combined gamified elements vs. individual gamified elements in increasing participants' DSC, and
4. Determine the potential effectiveness of utilizing implicit gamification compared to explicit gamification and their effects on increasing DSC and percentage of meeting DSGs.

This will be a randomized controlled trial. The study will recruit 300 participants from Taipei Medical University and randomly distribute them into four groups by having them pick a unique number from a bowl: (1) control, (2) individual gamified elements group, (IGG), (3) combined gamified elements group (CGG), and (4) Explicit Gamification Group (EGG). Informed consent will be collected. The study will take measurements at three points in time: (1) the initial check-in, (2) end of the experiment (8 weeks), and (3) one-month follow-up (12 weeks). These measurements include blood pressure, heart rate, Body Mass Index (BMI), Waist-to-Hip Ratio (WHR), Body Fat Percentage, Muscle Mass, Bone Density, Body Fluid Amount, and answering a questionnaire consisting of International Physical Activity Questionnaire - Short Form (IPAQ-SF), Pittsburgh Sleep Quality Index - Chinese version (PSQI-C), Insomnia Severity Index - Chinese Version (ISI-C), and the 12-item Short Form Survey (SF-12).

The experimental period of the study will last 8 weeks with a 4-week follow-up, for a total of 12 weeks. After completing the initial check-in and submitting their informed consent forms, participants will be asked to download Google Fit (if they don't already have the app installed) and add the study's official LINE account.

Control group participants will be prompted at the end of the experiment (Week 8) to submit a screenshots of their weekly averages of their DSC from Google Fit. This, along with the questionnaire portions (at Weeks 8 and 12), will be the only time that the research team will contact the control group.

For the first week of the study, the IGG, CGG, and EGG participants will be asked to develop a baseline of their daily step count (DSC). Participants will not be contacted or reminded to meet any certain DSC during this period of seven days. After the first week, the research team will contact the participants and ask them to submit their weekly DSC average (found in Google Fit) and establish a self-set daily step count goal (DSG), which will be an increase of 25%, 33%, or 50% of baseline - for at least an increase of 1,000 steps.

For the second week of the study, the research team will utilize nudging to remind participants to meet their self-set DSGs. The official LINE account will send two messages per day at 10 AM and 7 PM as a reminder to meet their DSGs - the morning message will be a more generalized message while the nighttime message will include a reminder to submit a screenshot of their daily step count via Google Fit - the study's way of monitoring the participants' DSC and DSGs.

For the rest of the experiment, EGG participants will download Pikmin Bloom and Pokémon Sleep, and play the games for the duration of the study period. The games will be explained below.

For the third week of the study, the research team will notify the IGG and CGG participants to meet their DSGs to gain points towards an additional financial incentive at the end of the study. Participants can gain a total of 70 points each week (10 points per day) if they meet their DSGs, and will not gain points if they fail to meet their DSGs. Starting from this section, the IGG and CGG will begin to differentiate, with the IGG not receiving the nudging messages from the previous week and the CGG continuing to receive messages until the end of the study. CGG participants will also be eligible for further weekly financial incentives if they meet their weekly goals for the rest of the study for up to a total of $1,000 NTD; their points will be reset at the beginning of each week.

For the fourth week of the study, a leaderboard will be used. IGG and CGG participants will begin competing against each other within their designated groups (e.g. IGG participants will compete with each other, CGG participants will compete with each other). A leaderboard will be updated daily at noon and include participants' daily step count over the week. Participants will be reminded to submit their DSC or risk losing points for that day. CGG participants will continue to receive daily notifications twice a day; points will also be reset this week to emulate the fresh start theory.

For the fifth and sixth week of the study, IGG and CGG participants will be placed into groups of three and randomly selected to compete with another team within their intervention clusters. We will use an online software (https://www.randomlists.com/team-generator) to randomize the 60 participants into 20 groups. They will face different teams during the two weeks. This section will emulate social aspects, as participants will have to collaborate within their team while also competing against other participants. One participant within each group will be randomly selected each day to represent the group; therefore, this promotes communication and collaboration among group members to encourage each other to meet their DSGs to gain points. Teams will be notified at the beginning of each day whether or not their opponents have met their DSGs and gained points. The CGG participants will continue receiving notifications daily, along with gaining points for their individual goal and also competing against everyone on the leaderboard.

For the seventh and eighth week of the study, participants will be asked to download a mobile game - Pikmin Bloom - to assist in meeting their DSGs.

Pikmin Bloom is a mobile application focused on increasing the user's daily step count via personalized avatar, progression, and various in-game rewards. The game will tie into the user's smartphone's native health application (Apple Health for iOS or Google Fit for Android) and link the daily step count to the game. The game provides a daily summary of the user's steps at night, which helps users reflect on their DSC.

Participants will create an account and be asked to interact with the games. Pikmin Bloom will track their daily steps. Participants will use Pikmin Bloom to track their steps and submit their DSC screenshot to the research team from within the mobile game instead of a screenshot of Google Fit. Participants can create an avatar and will progress towards certain goals given within the game. The game is mainly based on DSC and players progress when certain goals are achieved via DSC. IGG participants will be tasked with submitting a screenshot of the in-game DSC screen. CGG participants will also submit screenshots of their DSC via Pikmin Bloom, alongside receiving notifications, points, monitoring the daily leaderboard, and competing against their randomly assigned opponents.

After the conclusion of the experiment, participants will be asked to come in to complete the second questionnaire and measurements. The research team will remind them that a follow-up will be performed four weeks from the end of the experiment.

Eligibility criteria: Inclusion Criteria:

* Taipei Medical University student
* Ages 18 - 35
* Access to smartphone
* LINE messaging account
* Provide Informed Consent

Exclusion Criteria:

* Not currently participating in other studies regarding health
* Cannot commit to the entire study period (12 weeks)

Primary outcomes:
measure: Increase Daily Step Count and Daily Step Goals Met with Gamified Elements
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
Secondary outcomes:
measure: Potential Effectiveness of Increased DSC on health indicators
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Potential Effectiveness of Increased DSC on health indicators
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Potential Effectiveness of Increased DSC on health indicators
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Potential Effectiveness of Increased DSC on health indicators
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Potential Effectiveness of Increased DSC on health indicators
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Potential Effectiveness of Increased DSC on health indicators
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Potential Effectiveness of Increased DSC on health indicators
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Potential Effectiveness of Increased DSC on health indicators
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Potential Effectiveness of Increased DSC on health indicators
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Effectiveness of Individual Gamified Elements vs. Combined Gamified Elements
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Implicit vs. Explicit Gamification Effect on Participant DSC
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Potential Effectiveness of Increased DSC on sleep behavior and quality
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Potential Effectiveness of Increased DSC on sleep behavior and quality
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
measure: Potential Effectiveness of Increased DSC on mental health and well-being
timeFrame: 12 weeks (8 week experiment, 4 week follow-up)
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Feng-Jen Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yao J, Lim N, Tan J, Matthias Muller A, Martinus van Dam R, Chen C, Tan CS, Muller-Riemenschneider F. Evaluation of a Population-Wide Mobile Health Physical Activity Program in 696 907 Adults in Singapore. J Am Heart Assoc. 2022 Jun 21;11(12):e022508. doi: 10.1161/JAHA.121.022508. Epub 2022 Jun 14.
citation: Agarwal AK, Waddell KJ, Small DS, Evans C, Harrington TO, Djaraher R, Oon AL, Patel MS. Effect of Gamification With and Without Financial Incentives to Increase Physical Activity Among Veterans Classified as Having Obesity or Overweight: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116256. doi: 10.1001/jamanetworkopen.2021.16256.
citation: Fanaroff AC, Patel MS, Chokshi N, Coratti S, Farraday D, Norton L, Rareshide C, Zhu J, Szymczak JE, Russell LB, Small DS, Volpp KGM. A randomized controlled trial of gamification, financial incentives, or both to increase physical activity among patients with elevated risk for cardiovascular disease: rationale and design of the be active study. Am Heart J. 2023 Jun;260:82-89. doi: 10.1016/j.ahj.2023.02.014. Epub 2023 Mar 2.
citation: Patel MS, Small DS, Harrison JD, Hilbert V, Fortunato MP, Oon AL, Rareshide CAL, Volpp KG. Effect of Behaviorally Designed Gamification With Social Incentives on Lifestyle Modification Among Adults With Uncontrolled Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2021 May 3;4(5):e2110255. doi: 10.1001/jamanetworkopen.2021.10255.
citation: 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.