"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"
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
1 other identifier
interventional
126
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Oct 2026
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2026
CompletedFirst Posted
Study publicly available on registry
July 6, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
Study Completion
Last participant's last visit for all outcomes
April 1, 2027
July 6, 2026
July 1, 2026
6 months
June 22, 2026
July 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Baseline (week 0) and post-intervention (week 20)
Secondary Outcomes (22)
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)
- +17 more secondary outcomes
Study Arms (3)
Supervised In-Person Training (EG-1)
EXPERIMENTALParticipants attend two supervised group exercise sessions per week (Tuesdays and Thursdays, 60 min/session) at the Municipal Sports Center of Osuna over 20 weeks (40 sessions total). The program follows a progressive 4-phase resistance training protocol (adaptation, initial progression, intermediate progression, and consolidation) based on ADA, ACSM, and WHO guidelines for T2D and obesity. Heart rate, RPE, and oxygen saturation are monitored each session. All participants receive a Fitbit Charge 6 wearable device, weekly motivational text messages, and two group health coaching sessions (weeks 4 and 12).
Unsupervised mHealth Training (EG-2)
EXPERIMENTALParticipants follow the identical 20-week, 4-phase progressive resistance training program as EG-1, delivered autonomously via the ActiVital mobile application (Andalusian Physical Activity Prescription Plan, PAPEF 2023-2030). Participants access their weekly training plan through the app and confirm session completion within the platform. All participants receive a Fitbit Charge 6 wearable device, weekly motivational text messages, and two group health coaching sessions (weeks 4 and 12).
Usual Care Control Group (CG)
ACTIVE COMPARATORParticipants continue their standard medical care as prescribed by their primary care physician, with no structured exercise intervention. They receive a Fitbit Charge 6 wearable device for activity monitoring and two weekly text messages reminding them to use the device and attend scheduled assessments. Group health coaching sessions are provided at weeks 4 and 12, consistent with the other arms. No exercise plan is delivered.
Interventions
Progressive 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.
Identical 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.
All 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.
Two 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.
All 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.
Participants 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Escuela Universitaria de Osunalead
- University of Sevillecollaborator
Study Sites (1)
José Manuel Jurado Castro
Osuna, Sevilla, 41640, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
June 22, 2026
First Posted
July 6, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
July 6, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share