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.
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)
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
Parallel
Supervised Exercise Training Program
BehavioralProgressive 20-week resistance training program delivered in-person, twice weekly (Tuesdays and Thursdays), in 60-minute supervised group sessions at the Municipal Sports Center of Osuna. The program comprises 40 sessions organized into four phases: adaptation (sessions 1-8), initial progression (sessions 9-20), intermediate progression (sessions 21-32), and functional consolidation (sessions 33-40). Exercises target major muscle groups using bodyweight, resistance bands, and dumbbells. Session structure: 10-min warm-up, 40-min main block, 10-min cool-down. Intensity is monitored via heart rate (Fitbit Charge 6), RPE scale, and pulse oximetry. Prescribed in accordance with ADA, ACSM, and WHO guidelines for T2DM and obesity.
mHealth Unsupervised Exercise Program (ActiVital App)
BehavioralIdentical 20-week progressive resistance training program as Intervention 1, delivered autonomously via the ActiVital mobile application, the official digital platform of the Andalusian Physical Activity and Exercise Prescription Plan (PAPEF 2023-2030). Participants access their individualized weekly training plan through the app and log session completion within the platform after each workout. Initial onboarding and basic app training are provided at study entry.
Wearable Device Monitoring (Fitbit Charge 6)
DeviceAll participants across the three study arms receive a Fitbit Charge 6 consumer-grade wearable device associated with the Fitbit mobile application. The device continuously monitors physical activity indicators including resting and active heart rate, daily step count, energy expenditure, and sleep quality parameters throughout the 20-week study period. Data are accessible to participants via the Fitbit app.
Health Coaching Sessions
BehavioralTwo group health coaching sessions are delivered to all participants at weeks 4 and 12 of the intervention. Sessions focus on lifestyle habits relevant to the management of T2D and obesity, including physical activity, dietary behavior, sleep hygiene, and weight management. Coaching is conducted in person by the research team and aims to reinforce behavioral change and promote long-term adherence.
Weekly Motivational Text Messages
BehavioralAll participants receive two motivational text messages per week throughout the 20-week study period. Messages address topics related to physical activity, diet, sleep, and weight management, and serve as reminders to use the wearable device daily and attend scheduled assessment appointments.
Usual Medical Care
Other interventionParticipants in the control group continue their standard medical care as prescribed by their primary care physician at the Primary Care Center of Osuna, without any structured exercise intervention. This includes routine clinical follow-up, pharmacological treatment, and general lifestyle recommendations as per standard clinical practice for T2D and obesity.
Change from Baseline in Glycated Hemoglobin (HbA1c) at 20 Weeks
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).
Change from Baseline in Fasting Blood Glucose at 20 Weeks
Fasting blood glucose measured after a minimum 8-hour fast using an Accu-Chek Inform II glucometer. Values expressed in mg/dL. Higher values indicate poorer glycemic control. Diabetes diagnostic threshold: fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L).
Change from Baseline in Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides) at 20 Weeks
Full lipid panel obtained via venous blood draw after a 9-12 hour fast. Includes total cholesterol, LDL, HDL, and triglycerides, all expressed in mg/dL. Lower LDL and triglycerides and higher HDL indicate a more favorable cardiovascular risk profile.
Change from Baseline in Resting Systolic and Diastolic Blood Pressure at 20 Weeks
Resting blood pressure measured manually using an OMRON sphygmomanometer and Littmann stethoscope after 5 minutes of seated rest. Systolic and diastolic values recorded separately in mmHg. Lower values indicate better cardiovascular health.
Change from Baseline in High-Sensitivity C-Reactive Protein (CRP) at 20 Weeks
Systemic inflammatory marker measured via venous blood draw, analyzed in a certified laboratory. Expressed in mg/L. Higher values indicate greater systemic inflammation and increased cardiometabolic risk in individuals with T2DM and obesity.
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Escuela Universitaria de Osuna
Lead sponsor
University of Seville
Collaborator
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