"Effectiveness of Supervised and Unsupervised mHealth-based Exercise Interventions on Clinical Ou… (NCT07685080) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
"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"
Spain126 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares supervised versus unsupervised exercise programs using mobile health apps and wearable devices — can you help me understand what the day-to-day commitment of each approach would look like, and whether either fits my current lifestyle?
2Since this trial isn't recruiting yet, how long might it be before I could actually enroll, and is waiting a reasonable option given where my HbA1c and weight are right now?
3The study is taking place in a primary care setting and is listed as Phase NA, meaning it's testing a practical program rather than a new drug — does that change what we know about the risks compared to a standard exercise recommendation you might already give me?
4The main thing being measured is change in HbA1c over 20 weeks — based on where my levels are today, is a 20-week exercise intervention a realistic timeline for me to see meaningful improvement, or should we be thinking about other treatments alongside or instead of this?
5Because this trial involves wearable devices and a mobile app to track my activity, are there any concerns about my ability to use that technology reliably, and would that affect whether this study would even be a good fit to discuss with the research team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Glycated Hemoglobin (HbA1c) at 20 Weeks
Timeframe: Baseline (week 0) and post-intervention (week 20)