"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"

Sponsor
Escuela Universitaria de Osuna
Study ID
NCT07685080
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Supervised Exercise Training Program — BEHAVIORAL
    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.
  • mHealth Unsupervised Exercise Program (ActiVital App) — BEHAVIORAL
    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.
  • Wearable Device Monitoring (Fitbit Charge 6) — DEVICE
    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.
  • Health Coaching Sessions — BEHAVIORAL
    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.
  • Weekly Motivational Text Messages — BEHAVIORAL
    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.
  • Usual Medical Care — OTHER
    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.

Study Details

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 Dates

First listed
Jul 6, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Mar 30, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Supervised In-Person Training (EG-1)
    Participants 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).
  • Experimental: Unsupervised mHealth Training (EG-2)
    Participants 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).
  • Active Comparator: Usual Care Control Group (CG)
    Participants 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.

Primary Outcome Measure

Change from Baseline in Glycated Hemoglobin (HbA1c) at 20 Weeks [ Time Frame: Baseline (week 0) and post-intervention (week 20) ]

Central Contacts

Find similar trials

Nationwide
Type 2 diabetes trialsObesity / overweight trialsEndocrinology trialsMetabolic health trialsWeight loss trials

Related Studies