Effectiveness of Supervised and Unsupervised mHealth-based Exercise Interventions on Clinical Outcomes in Adults With Type 2 Diabetes and Obesity Within a Primary Care Context: a Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change from Baseline in Glycated Hemoglobin (HbA1c) at 20 Weeks
研究概览
简要总结
Type 2 diabetes (T2D) and obesity are two of the most common chronic conditions worldwide, and they frequently occur together. Both conditions are closely linked to physical inactivity, which is currently recognized as a major risk factor for a wide range of diseases. Although structured exercise programs have shown benefits for people living with these conditions, maintaining long-term participation remains a significant challenge. The rise of mobile health (mHealth) technologies - such as smartphone apps and wearable devices - offers a promising new way to support people in becoming and staying more physically active.
This study aims to compare the effects of two different 20-week exercise intervention programs versus standard medical care in adults aged 30 to 65 who have been diagnosed with both T2D and obesity.
Participants will be randomly assigned to one of three groups:
Group 1 (Supervised Training): Participants will attend two in-person, supervised exercise sessions per week at a local sports facility, each lasting 60 minutes. Sessions will be led by a qualified trainer and will include strength, flexibility, and functional exercises. Participants will also receive weekly motivational text messages and group health coaching.
Group 2 (Unsupervised mHealth Training): Participants will follow the same exercise plan independently using a mobile application (ActiVital), which is part of the Andalusian Physical Activity Prescription Plan (PAPEF). They will receive their weekly training schedule through the app and will also receive text messages and group health coaching.
Group 3 (Control Group): Participants will continue with their usual medical care without any structured exercise program.
All participants across the three groups will be provided with a Fitbit Charge 6 wearable device to monitor daily physical activity and health indicators.
The study's central hypothesis is that both structured supervised exercise and app-guided unsupervised exercise will lead to meaningful improvements in clinical indicators - such as blood glucose levels, glycated hemoglobin (HbA1c), blood lipids, and blood pressure - as well as in body composition, physical fitness, sleep quality, and overall quality of life, when compared to standard care alone. It is also hypothesized that the mHealth approach will show particular benefits in terms of adherence, self-management, and scalability.
A total of 126 participants will be recruited through the Primary Care Center of Osuna (Seville, Spain), with measurements taken before and after the 20-week intervention period. The study will help determine which type of exercise program is most effective and feasible for people managing both type 2 diabetes and obesity in a primary care setting.
详细描述
Background and Rationale
Type 2 diabetes (T2D) and obesity represent a growing global health burden, both individually and as comorbid conditions. Physical inactivity is recognized as the fourth leading cause of death worldwide and is directly implicated in the development and progression of both pathologies. While lifestyle interventions combining exercise and behavioral change have demonstrated efficacy in improving glycemic control and metabolic profile, their long-term effectiveness remains limited due to poor adherence and lack of scalability. Mobile health (mHealth) interventions - delivered via smartphones, wearable devices, and digital platforms - have emerged as a promising complementary strategy to extend the reach of structured exercise programs beyond traditional clinical settings.
Despite a growing body of evidence supporting mHealth for T2D and obesity independently, no study to date has rigorously evaluated the comparative effectiveness of supervised versus app-guided unsupervised exercise interventions in patients presenting with both conditions concurrently.
Study Design
This is a 20-week, three-arm, parallel-group randomized controlled trial (RCT) conducted at the Primary Care Center of Osuna, Seville, Spain. Exercise sessions will take place at the covered indoor facilities of the Municipal Sports Center of Osuna. The trial will compare two active intervention arms against a usual care control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the exercise interventions, masking of participants, care providers, and investigators is not feasible. However, all pre- and post-intervention assessments will be conducted by external evaluators who are blinded to group allocation.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with both type 2 diabetes mellitus and obesity
- •Aged between 30 and 65 years
- •Body Mass Index (BMI) between 30 and 40 kg/m²
- •Glycated hemoglobin (HbA1c) greater than 6.5% (48 mmol/mol)
- •Fasting plasma or capillary blood glucose equal to or greater than 126 mg/dL (7.0 mmol/L)
- •Willing and able to provide informed consent to participate in the study
- •Available and willing to commit to a 20-week intervention period
- •Able and willing to use a smartphone and receive text messages
- •Able and willing to use a wearable device (smartwatch) and its associated mobile application
排除标准
- •Presence of any obesity-related comorbidity requiring clinical referral, including eating disorders, pseudotumor cerebri, sleep apnea, hypoventilation syndrome, or orthopedic problems that limit physical activity
- •Presence of psychiatric or medical conditions that would prevent compliance with the study protocol
- •History of a cardiovascular event (myocardial infarction, stroke, heart failure episode, or revascularization procedure) in the past 6 months
- •Presence of any medical condition that contraindicates participation in the proposed physical activity program
- •Current use of insulin therapy
- •Presence of orthopedic or other physical limitations that may interfere with the ability to exercise safely
- •Currently undergoing treatment for a malignant tumor (other than non-melanoma skin cancer)
- •Currently receiving treatment for, or diagnosed with, an eating disorder
- •Planned bariatric or weight-loss surgery (e.g., liposuction, gastric band, gastric bypass) within the next 5 months
- •Currently pregnant, given birth in the last 6 months, breastfeeding in the last 3 months, or actively planning a pregnancy in the next 5 months
- •Currently enrolled in, or planning to enroll in, a weight loss program during the study period
- •Lost more than 5 kilograms of body weight in the past 3 months
结局指标
主要结局
Change from Baseline in Glycated Hemoglobin (HbA1c) at 20 Weeks
时间窗: Baseline (week 0) and post-intervention (week 20)
Glycated hemoglobin (HbA1c) reflects average blood glucose over the preceding 2-3 months and is the standard marker for long-term glycemic control in type 2 diabetes. Measured via venous blood draw after a 9-12 hour fast, analyzed in a certified laboratory. Expressed as a percentage (%). Higher values indicate poorer glycemic control. Diabetes diagnostic threshold: HbA1c ≥ 6.5% (48 mmol/mol).
次要结局
- Change from Baseline in Fasting Blood Glucose at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides) at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Resting Systolic and Diastolic Blood Pressure at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in High-Sensitivity C-Reactive Protein (CRP) at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Renal Function (Creatinine and eGFR) and Hepatic Transaminases (GOT/GPT) at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Body Mass at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Body Mass Index (BMI) at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Body Fat Percentage at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Skeletal Muscle Mass at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Waist Circumference at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Hip Circumference at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Waist-to-Hip Ratio at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Aerobic Capacity as Assessed by the 6-Minute Walk Test at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Lower Limb Strength as Assessed by the 30-Second Sit-to-Stand Test at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Jump Height as Assessed by the Countermovement Jump Test at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Explosive Power as Assessed by the Countermovement Jump Test at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Take-off Velocity as Assessed by the Countermovement Jump Test at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Functional Mobility as Assessed by the Timed Up and Go Test at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Gait Speed as Assessed by the 6-Meter Walk Test at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Sleep Quality and Daily Physical Activity Level as Assessed by Accelerometry at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Change from Baseline in Health-Related Quality of Life as Assessed by the SF-36 Health Survey at 20 Weeks(Baseline (week 0) and post-intervention (week 20))
- Adherence to the Assigned Exercise Intervention Over 20 Weeks(Continuously monitored throughout the 20-week intervention period)
研究者
Jose Manuel Jurado-Castro
Doctor
Escuela Universitaria de Osuna