Effect of Mobile Health-Based Gamified Long-Term Interventions to Increase Physical Activity on Cardiovascular Risk Factors: Randomized Controlled Study on University Students and Employees (mHealth Exerc)

June 5, 2026 updated by: Ramiz ARABACI, Uludag University

Effect of Mobile Health-Based Gamified Long-Term Interventions to Increase Physical Activity on Cardiovascular Risk Factors

The increasing incidence of cardiovascular disease (CVD) and related mortality is now recognized as a global emergency. CVD risk factors include unhealthy diet, inactivity, dyslipidemia, diabetes, high blood pressure, obesity, smoking, and family history/genetics. Increasing physical activity (PA) is recognized as an essential factor in reducing the risk of CVD. Many studies have emphasized that regular and adequate physical activity significantly reduces the risk of CVD through effects such as lowering blood pressure and cholesterol levels, supporting weight control, and improving diabetes management. Measuring steps/day is used to determine PA, and as technologies have developed, smartphones have become widely used tools. Inactivity and time constraints of modern life make it difficult for people to increase PA levels. Therefore, innovative intervention methods based on mobile health and gamification should be used to improve individuals' physical activity. Gamification is the application of game design elements such as points, badges, leaderboards, and levels in non-game environments. Gamification is increasingly being used to create change, particularly in physical activity and health behaviors. It is recommended to include resistance exercises at least 2 days a week in addition to aerobic activity to maximize health benefits. Recently, the high-intensity circuit training (HICT) program, which combines high-intensity interval training (HIIT) and circuit training (CT), requires less time, combines aerobic and resistance exercises, and uses body weight, has been developed and is used in sports. The main aim of the present study is to examine the effects of 12-week Mobile Health-Based Gamified applications on cardiovascular risk factors among university students and employees. In this direction, it is aimed to increase participants' daily steps and improve their physical activity habits. A total of 105 volunteers aged 18 to 64, including students and employees of Bursa Uludag University, will participate in the study. PACER pedometer and 7 Minute Workout HICT exercise mobile health applications will be used in the study.

Subjects will be divided into five equal groups of 21 people each using the closed opaque envelope randomization method. Walking intervention (WG), gamified walking intervention (GWG), walking and exercise intervention (WEG), gamified walking and exercise intervention (GWEG), and control (CG) groups will be formed. The first four groups (WG, GWG, WEG, and GWEG) will walk every day for 12 weeks to reach the set target number of steps. In addition, volunteers in the GWEG and WEG group will exercise (HICT) for at least 15 minutes on 3 designated days per week in addition to walking. In addition, volunteers in the GWG and GWEG groups will use a gamified application. In CG, there will be no regular physical activity, and they will continue their daily lifestyle. In our study, unlike those conducted to date, the application of HICT with gradually increasing physical activity for 12 weeks to reduce CVD risk factors, and the use of gamified methods to stay in the program and ensure sustainability, emphasize its unique value. The gamified exercise program applied in this study is expected to provide an additional benefit for CVD risk factors compared with the protocols used to date.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • NİLÜFER
      • Bursa, NİLÜFER, Turkey (Türkiye), 16120
        • Uludağ University, Faculty of Spor Science Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being among 18 or 65
  • To give verbal and written consent to participate in the study voluntarily

Exclusion Criteria:

  • If there are any health issues
  • IPAQ>= 3000 MET / day (IPAQ: International Physical Activity Questionnaire - Short Form)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Walking intervention (WG)
Participants will walk daily for 12 weeks to achieve a predetermined step goal.
Behavioral: Walking program
Walk daily for 12 weeks to achieve a predetermined step goal.
Experimental: Gamified walking intervention (GWG)
Participants will walk daily for 12 weeks to achieve a predetermined step goal and will use a gamified application to support their walking.
Behavioral: Walking program
Walk daily for 12 weeks to achieve a predetermined step goal.
Behavioral: Gamified Mobile Application
Use of a gamified application designed to promote motivation, adherence, and engagement in walking and exercise activities during the 12-week intervention period.
Experimental: Walking and exercise intervention (WEG)
Participants will walk daily for 12 weeks to achieve a predetermined step goal, perform high-intensity circuit training (HICT) for at least 15 minutes on three designated days per week.
Behavioral: Walking program
Walk daily for 12 weeks to achieve a predetermined step goal.
Behavioral: High-intensity circuit training (HICT)
High-intensity circuit training performed for at least 15 minutes on three designated days per week for 12 weeks, in addition to daily walking.
Experimental: Gamified walking and exercise intervention (GWEG)
Participants will walk daily for 12 weeks to achieve a predetermined step goal, perform high-intensity circuit training (HICT) for at least 15 minutes on three designated days per week, and use a gamified application to support walking and exercise activities.
Behavioral: Walking program
Walk daily for 12 weeks to achieve a predetermined step goal.
Behavioral: Gamified Mobile Application
Use of a gamified application designed to promote motivation, adherence, and engagement in walking and exercise activities during the 12-week intervention period.
Behavioral: High-intensity circuit training (HICT)
High-intensity circuit training performed for at least 15 minutes on three designated days per week for 12 weeks, in addition to daily walking.
No Intervention: Control group (CG)
Participants will not receive any structured physical activity intervention and will continue their usual daily lifestyle throughout the study period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body Composition and Anthropometric Measurements
Time Frame: From enrollment to the end of treatment at 12 weeks
Body composition parameters will be assessed in study participants. Body weight (kg) and body fat percentage will be measured using the TANITA BC 418 MA device via bioelectrical impedance analysis. Waist and hip circumference measurements will be obtained using a measuring tape with 1 mm precision while participants are standing upright on a flat surface. Waist circumference will be measured at the level of the umbilicus, and hip circumference will be measured at the widest part of the hips by wrapping the measuring tape completely around the body. Body mass index (BMI) will be calculated by dividing body weight (kg) by the square of height (m²).
From enrollment to the end of treatment at 12 weeks
Cardiovascular Disease Risk Factors
Time Frame: From enrollment to the end of treatment at 12 weeks
Cardiovascular disease (CVD) risk factors will be assessed according to the criteria defined by the American College of Sports Medicine (ACSM). Blood biochemical parameters, including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose, will be analyzed at the university hospital laboratory where the study is conducted. Systolic and diastolic blood pressure will be measured using an automated blood pressure monitor (Omron M2 Intellisense). Blood pressure will be measured in the right arm and repeated 3 times, with the mean used for analysis.
From enrollment to the end of treatment at 12 weeks
Physical Activity Level Assessed by the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time Frame: From enrollment to the end of treatment at 12 weeks
Participants' physical activity levels will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), which is designed for individuals aged 15 to 65 years. The IPAQ-SF consists of seven items that assess the frequency and duration of walking, moderate-intensity physical activity, and vigorous-intensity physical activity over the previous 7 days.
From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Daily Step Count Monitored via Google Fit
Time Frame: From enrollment to the end of treatment at 12 weeks
Participants' daily step counts will be monitored using the Google Fit mobile application over 3 months. The intervention aims to increase the average daily step count during the monitoring period. Step count data recorded by Google Fit will be used for analysis.
From enrollment to the end of treatment at 12 weeks
Exercise Adherence to High-Intensity Circuit Training (HICT) via the "7 Minute Workout" Mobile Application
Time Frame: From enrollment to the end of treatment at 12 weeks
Exercise participation will be monitored using the "7 Minute Workout" mobile application. Participants will be instructed to perform high-intensity circuit training (HICT) exercises at least three days per week. The HICT protocol consists of 12 high-intensity, bodyweight-based exercises and is evidence-based and supported by the American College of Sports Medicine (ACSM). Exercise adherence will be evaluated based on application-recorded activity data.
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uludag University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-20/1
  • 324K201 (Other Identifier: TUBITAK 1002-A)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ethical issues

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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