"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"

Starting soon · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Obesity, Insulin Resistance, Sedentary Behaviors, mHealth, Physical Exercise, Primary Care, Wearable Devices

In brief

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.

Key facts

Study ID: NCT07685080
Run by: Escuela Universitaria de Osuna
People needed: 126
Starts: 2026-10-01
Expected to finish: 2027-04-01
Last updated by the study team: 2026-07-06

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

José Manuel Jurado Castro — Osuna, Sevilla, Spain

Full record on ClinicalTrials.gov

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