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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Walking program
  Walk daily for 12 weeks to achieve a predetermined step goal.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Body Composition and Anthropometric Measurements [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Cardiovascular Disease Risk Factors [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Physical Activity Level Assessed by the International Physical Activity Questionnaire-Short Form (IPAQ-SF) [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (2)

• Daily Step Count Monitored via Google Fit [Срок оценки: 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 [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Uludağ University, Faculty of Spor Science Lab — Bursa

Идентификаторы

NCT: NCT07360561 · 2024-20/1 · 324K201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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