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临床试验/NCT06818071
NCT06818071已完成不适用

Application of Gamified Elements to Increase Daily Step Count in University Students in Taiwan A Randomized Controlled Trial

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
255
试验地点
1
主要终点
Increase Daily Step Count and Daily Step Goals Met with Gamified Elements

研究概览

简要总结

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: 255 participants were 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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

Control Group

No Intervention

Participants in this group will not interact with the study during the study period, but will complete body measurements and questionnaires at Week 1, 9, and 12 and provide weekly daily step count averages for the study period.

Individual Gamified Elements Group (IGG)

Experimental

IGG Participants interact with each gamified element one by one. They will will set a daily step goal after developing a baseline during the first week. During the subsequent weeks, IGG participants will receive health information on a daily basis (Week 2), gain points for a 7-11 gift card (Week 3), compete with their group on a leaderboard (Week 4), group up with other IGG participants and compete with other groups (Weeks 5 & 6), then play a mobile game that focuses on explicit gamification (Pikmin Bloom, Weeks 7 & 8). IGG Participants will complete the TANITA body measurement, blood pressure & heart rate, waist & hip circumference, and the questionnaire at Weeks 1, 9, & 12.

干预措施: Points and Leaderboards (Behavioral)

Individual Gamified Elements Group (IGG)

Experimental

IGG Participants interact with each gamified element one by one. They will will set a daily step goal after developing a baseline during the first week. During the subsequent weeks, IGG participants will receive health information on a daily basis (Week 2), gain points for a 7-11 gift card (Week 3), compete with their group on a leaderboard (Week 4), group up with other IGG participants and compete with other groups (Weeks 5 & 6), then play a mobile game that focuses on explicit gamification (Pikmin Bloom, Weeks 7 & 8). IGG Participants will complete the TANITA body measurement, blood pressure & heart rate, waist & hip circumference, and the questionnaire at Weeks 1, 9, & 12.

干预措施: Social Aspects (Behavioral)

Individual Gamified Elements Group (IGG)

Experimental

IGG Participants interact with each gamified element one by one. They will will set a daily step goal after developing a baseline during the first week. During the subsequent weeks, IGG participants will receive health information on a daily basis (Week 2), gain points for a 7-11 gift card (Week 3), compete with their group on a leaderboard (Week 4), group up with other IGG participants and compete with other groups (Weeks 5 & 6), then play a mobile game that focuses on explicit gamification (Pikmin Bloom, Weeks 7 & 8). IGG Participants will complete the TANITA body measurement, blood pressure & heart rate, waist & hip circumference, and the questionnaire at Weeks 1, 9, & 12.

干预措施: Health Messages (Behavioral)

Individual Gamified Elements Group (IGG)

Experimental

IGG Participants interact with each gamified element one by one. They will will set a daily step goal after developing a baseline during the first week. During the subsequent weeks, IGG participants will receive health information on a daily basis (Week 2), gain points for a 7-11 gift card (Week 3), compete with their group on a leaderboard (Week 4), group up with other IGG participants and compete with other groups (Weeks 5 & 6), then play a mobile game that focuses on explicit gamification (Pikmin Bloom, Weeks 7 & 8). IGG Participants will complete the TANITA body measurement, blood pressure & heart rate, waist & hip circumference, and the questionnaire at Weeks 1, 9, & 12.

干预措施: Pikmin Bloom (Behavioral)

Combined Gamified Elements Group (CGG)

Experimental

CGG Participants interact with gamified element by adding additional ones each week. They will will set a daily step goal after developing a baseline during the first week. During the subsequent weeks, ICGG participants will receive health information on a daily basis (Week 2-8), gain points for a 7-11 gift card (Week 3-8), compete with their group on a leaderboard (Week 4-8), group up with other IGG participants and compete with other groups (Weeks 5-8), then play a mobile game that focuses on explicit gamification (Pikmin Bloom, Weeks 7-8). CGG Participants will complete the TANITA body measurement, blood pressure & heart rate, waist & hip circumference, and the questionnaire at Weeks 1, 9, & 12.

干预措施: Points and Leaderboards (Behavioral)

Combined Gamified Elements Group (CGG)

Experimental

CGG Participants interact with gamified element by adding additional ones each week. They will will set a daily step goal after developing a baseline during the first week. During the subsequent weeks, ICGG participants will receive health information on a daily basis (Week 2-8), gain points for a 7-11 gift card (Week 3-8), compete with their group on a leaderboard (Week 4-8), group up with other IGG participants and compete with other groups (Weeks 5-8), then play a mobile game that focuses on explicit gamification (Pikmin Bloom, Weeks 7-8). CGG Participants will complete the TANITA body measurement, blood pressure & heart rate, waist & hip circumference, and the questionnaire at Weeks 1, 9, & 12.

干预措施: Social Aspects (Behavioral)

Combined Gamified Elements Group (CGG)

Experimental

CGG Participants interact with gamified element by adding additional ones each week. They will will set a daily step goal after developing a baseline during the first week. During the subsequent weeks, ICGG participants will receive health information on a daily basis (Week 2-8), gain points for a 7-11 gift card (Week 3-8), compete with their group on a leaderboard (Week 4-8), group up with other IGG participants and compete with other groups (Weeks 5-8), then play a mobile game that focuses on explicit gamification (Pikmin Bloom, Weeks 7-8). CGG Participants will complete the TANITA body measurement, blood pressure & heart rate, waist & hip circumference, and the questionnaire at Weeks 1, 9, & 12.

干预措施: Health Messages (Behavioral)

Combined Gamified Elements Group (CGG)

Experimental

CGG Participants interact with gamified element by adding additional ones each week. They will will set a daily step goal after developing a baseline during the first week. During the subsequent weeks, ICGG participants will receive health information on a daily basis (Week 2-8), gain points for a 7-11 gift card (Week 3-8), compete with their group on a leaderboard (Week 4-8), group up with other IGG participants and compete with other groups (Weeks 5-8), then play a mobile game that focuses on explicit gamification (Pikmin Bloom, Weeks 7-8). CGG Participants will complete the TANITA body measurement, blood pressure & heart rate, waist & hip circumference, and the questionnaire at Weeks 1, 9, & 12.

干预措施: Pikmin Bloom (Behavioral)

Explicit Gamified Elements Group (EGG)

Experimental

EGG Participants interact with each gamified element one by one. They will will set a daily step goal after developing a baseline during the first week. During the subsequent weeks, EGG participants will play a mobile game that focuses on explicit gamification (Pikmin Bloom, Weeks 2-8). EGG Participants will complete the TANITA body measurement, blood pressure & heart rate, waist & hip circumference, and the questionnaire at Weeks 1, 9, & 12.

干预措施: Pikmin Bloom (Behavioral)

结局指标

主要结局

Increase Daily Step Count and Daily Step Goals Met with Gamified Elements

时间窗: 12 weeks (8 week experiment, 4 week follow-up)

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.

次要结局

  • Potential Effectiveness of Increased DSC on health indicators(12 weeks (8 week experiment, 4 week follow-up))
  • Potential Effectiveness of Increased DSC on sleep behavior and quality(12 weeks (8 week experiment, 4 week follow-up))
  • Effectiveness of Individual Gamified Elements vs. Combined Gamified Elements(12 weeks (8 week experiment, 4 week follow-up))
  • Implicit vs. Explicit Gamification Effect on Participant DSC(12 weeks (8 week experiment, 4 week follow-up))
  • Potential Effectiveness of Increased DSC on mental health and well-being(12 weeks (8 week experiment, 4 week follow-up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey Zen Liu

PhD Candidate

Taipei Medical University

研究点 (1)

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