NCT06818071

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: 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

January 17, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

Gamified ElementsGamificationDaily Step CountPhsyical ActivityHealth PromotionBehavioral Change

Outcome Measures

Primary Outcomes (1)

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

    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.

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

Secondary Outcomes (14)

  • Potential Effectiveness of Increased DSC on health indicators

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

  • Potential Effectiveness of Increased DSC on health indicators

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

  • Potential Effectiveness of Increased DSC on health indicators

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

  • Potential Effectiveness of Increased DSC on health indicators

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

  • Potential Effectiveness of Increased DSC on health indicators

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

  • +9 more secondary outcomes

Study Arms (4)

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.

Behavioral: Points and LeaderboardsBehavioral: Social AspectsBehavioral: Health MessagesBehavioral: Pikmin Bloom

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.

Behavioral: Points and LeaderboardsBehavioral: Social AspectsBehavioral: Health MessagesBehavioral: Pikmin Bloom

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.

Behavioral: Pikmin Bloom

Interventions

Participants will have the opportunity to gain points if they meet their self-set daily step goal throughout the experiment period. Participants will also compete with others in their own respective groups on a leaderboard in regards to each day's daily step count.

Also known as: PBLs
Combined Gamified Elements Group (CGG)Individual Gamified Elements Group (IGG)
Social AspectsBEHAVIORAL

Participants will be randomly assigned into groups of three to compete with other groups based on their daily step count. Each day, one participant will be randomly selected to represent the group against their opponent. If they walked more than their randomly selected opponent, the participant's group will receive a positive, encouraging message congratulating them for winning that day. If they did not walk more than their randomly selected opponent, they will receive a motivational message to encourage them to walk more.

Also known as: Collaboration, Competition, Teamwork
Combined Gamified Elements Group (CGG)Individual Gamified Elements Group (IGG)
Health MessagesBEHAVIORAL

Experiment participants will receive messages that encourage healthy behaviors. These include topics such as: nutrition, sleep, physical activity, and decreased consumption/use of unhealthy products (tobacco, alcohol, etc.).

Combined Gamified Elements Group (CGG)Individual Gamified Elements Group (IGG)
Pikmin BloomBEHAVIORAL

Participants will play the mobile game Pikmin Bloom, which encourages users to increase their daily step count and allows them to utilize various gamified elements to do so. The game has many gamified elements included, such as personalization and avatar, social aspects, competition, collaboration, progression, and many more.

Also known as: Explicit Gamification, Mobile gaming
Combined Gamified Elements Group (CGG)Explicit Gamified Elements Group (EGG)Individual Gamified Elements Group (IGG)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, Taiwan, 110, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 35699174BACKGROUND
  • 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.

    PMID: 34241628BACKGROUND
  • 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.

    PMID: 36870551BACKGROUND
  • 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.

    PMID: 34028550BACKGROUND
  • 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

MeSH Terms

Conditions

Motor Activity

Interventions

Intersectoral Collaboration

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Officials

  • Feng-Jen Tsai, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

January 17, 2025

First Posted

February 10, 2025

Study Start

April 1, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations