ExercisemHealth ExercNCT07360561
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
A study testing Walking program, High-intensity circuit training (HICT) and Gamified Mobile Application in people with Exercise and Physical Activity, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Exercise, Physical Activity, Gamification
- What is being tested?
- Walking program, High-intensity circuit training (HICT) and Gamified Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being among 18 or 65
- To give verbal and written consent to participate in the study voluntarily
Who cannot join
- If there are any health issues
- IPAQ>= 3000 MET / day (IPAQ: International Physical Activity Questionnaire - Short Form)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Uludağ University, Faculty of Spor Science Lab
Bursa, NİLÜFER, 16120
About this study
Official title: 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.
- Conditions
- Exercise, Physical Activity, Gamification, University Student, College Student
- Being tested
- Walking program, High-intensity circuit training (HICT), Gamified Mobile Application
- Keywords
- exercise, physical activity, gamification, university student, college student
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking programBehavioural
Walk daily for 12 weeks to achieve a predetermined step goal.
High-intensity circuit training (HICT)Behavioural
High-intensity circuit training performed for at least 15 minutes on three designated days per week for 12 weeks, in addition to daily walking.
Gamified Mobile ApplicationBehavioural
Use of a gamified application designed to promote motivation, adherence, and engagement in walking and exercise activities during the 12-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Walking intervention (WG) | Experimental | Participants will walk daily for 12 weeks to achieve a predetermined step goal. Receives: Behavioral: Walking program |
| Gamified walking intervention (GWG) | Experimental | Participants will walk daily for 12 weeks to achieve a predetermined step goal and will use a gamified application to support their walking. Receives: Behavioral: Walking program; Behavioral: Gamified Mobile Application |
| Walking and exercise intervention (WEG) | Experimental | 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. Receives: Behavioral: Walking program; Behavioral: High-intensity circuit training (HICT) |
| Gamified walking and exercise intervention (GWEG) | Experimental | 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. Receives: Behavioral: Walking program; Behavioral: High-intensity circuit training (HICT); Behavioral: Gamified Mobile Application |
| Control group (CG) | No intervention | Participants will not receive any structured physical activity intervention and will continue their usual daily lifestyle throughout the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition and Anthropometric Measurements
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).
Measured: From enrollment to the end of treatment at 12 weeks
Cardiovascular Disease Risk Factors
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.
Measured: From enrollment to the end of treatment at 12 weeks
Physical Activity Level Assessed by the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (2)
Daily Step Count Monitored via Google Fit
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.
Measured: 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
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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start15 Apr 2025
- Primary completion20 Mar 2026
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of five parallel groups: walking intervention, gamified walking intervention, walking and exercise intervention, gamified walking and exercise intervention, or a no-intervention control group. All intervention groups will be followed concurrently for 12 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Ramiz ARABACI, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360561
- Sponsor's protocol ID
- 2024-20/1
- Other IDs
- 324K201
- Acronym
- mHealth Exerc
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical issues
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobile Health-Based Gamified Long-Term Interventions to Increase Physical Activity on Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT07360561
- Acronym / sponsor ID
- mHealth Exerc / 2024-20/1
- Conditions
- Exercise, Physical Activity, Gamification, University Student, College Student
- Keywords
- exercise, physical activity, gamification, university student, college student
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Jan 2026 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Participants will be randomly assigned to one of five parallel groups: walking intervention, gamified walking intervention, walking and exercise intervention, gamified walking and exercise intervention, or a no-intervention control group. All intervention groups will be followed concurrently for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Walking intervention (WG) | Experimental | Behavioral: Walking programParticipants will walk daily for 12 weeks to achieve a predetermined step goal. |
| Gamified walking intervention (GWG) | Experimental | Behavioral: Walking program, Behavioral: Gamified Mobile ApplicationParticipants will walk daily for 12 weeks to achieve a predetermined step goal and will use a gamified application to support their walking. |
| Walking and exercise intervention (WEG) | Experimental | Behavioral: Walking program, Behavioral: High-intensity circuit training (HICT)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. |
| Gamified walking and exercise intervention (GWEG) | Experimental | Behavioral: Walking program, Behavioral: High-intensity circuit training (HICT), Behavioral: Gamified Mobile ApplicationParticipants 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. |
| Control group (CG) | No intervention | –Participants will not receive any structured physical activity intervention and will continue their usual daily lifestyle throughout the study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being among 18 or 65
- To give verbal and written consent to participate in the study voluntarily
Key exclusion criteria (2 listed)
- If there are any health issues
- IPAQ>= 3000 MET / day (IPAQ: International Physical Activity Questionnaire - Short Form)
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 |
|---|---|---|
| Walking programWalk daily for 12 weeks to achieve a predetermined step goal. | Behavioural | Gamified walking and exercise intervention (GWEG), Gamified walking intervention (GWG), Walking and exercise intervention (WEG), Walking intervention (WG) |
| 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. | Behavioural | Gamified walking and exercise intervention (GWEG), Walking and exercise intervention (WEG) |
| Gamified Mobile ApplicationUse of a gamified application designed to promote motivation, adherence, and engagement in walking and exercise activities during the 12-week intervention period. | Behavioural | Gamified walking and exercise intervention (GWEG), Gamified walking intervention (GWG) |
Primary outcome
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).
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.
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.
2 secondary outcomes
Daily Step Count Monitored via Google Fit
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No. Ethical issues
Related trials for Exercise
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking program, High-intensity circuit training (HICT) and Gamified Mobile Application in people with Exercise and Physical Activity, run by Uludag University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 9 Jun 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Body Composition and Anthropometric Measurements (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.