About this trial
This study evaluates the effectiveness of a 3-month video-based lifestyle intervention, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with type 2 diabetes mellitus (DM2). Participants will be randomly allocated to receive the intervention either delivered by their own physician (experimental group) or by a physician unknown to them (control group). Assessment will include sociodemographic variables, glycated hemoglobin / HbA1c (primary outcome), body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the Mediterranean diet, therapeutic alliance, and health-related quality of life. The randomization process will be stratified according to HbA1c, therapeutic alliance, age, and sex.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-65 years
Diagnosis of type 2 diabetes mellitus
Under medical follow-up in participating centers
Access to the internet and a smartphone
Disqualifiers
Pregnancy
Type 1 diabetes or other specific forms of diabetes
Severe acute or unstable medical condition
Contraindication to diet or exercise
Trial design
Parallel
Treatments tested in this trial
Video-based lifestyle intervention (own physician)
BehavioralThe experimental group will receive the video-based lifestyle intervention delivered by their own physician, while the control group will receive identical content delivered by physicians unknown to the participants. The intervention consists of structured multimedia modules focusing on nutrition, physical activity, strength exercise, and psychological strategies to support behavior change.
Video-based lifestyle intervention (unknown physician)
BehavioralThe experimental group will receive the video-based lifestyle intervention delivered by their own physician, while the control group will receive identical content delivered by physicians unknown to the participants. The intervention consists of structured multimedia modules focusing on nutrition, physical activity, strength exercise, and psychological strategies to support behavior change.
Treatment groups
Trial outcomes
Primary outcomes
Glycated Hemoglobin (HbA1c)
HbA1c (%) will be used as the primary measure of glycemic control. It reflects average blood glucose levels over the previous 2-3 months and will be obtained from venous blood samples analyzed in routine clinical laboratories.
Secondary outcomes
Body Mass Index (BMI)
BMI will be calculated as weight divided by height squared (kg/m²).
Blood Pressure (Systolic and Diastolic)
Measured in mmHg following standardized clinical guidelines.
Lipid Profile
Total cholesterol, HDL, LDL, and triglycerides (mg/dL).
Physical Activity Level (IPAQ-SF)
Levels of Physical Activity will be assessed using the Short International Physical Activity Questionnaire (Short-IPAQ). This tool evaluates the frequency, duration, and intensity of physical activity, as well as sedentary behavior, in daily life. It estimates total physical activity in METs-min/week and records time spent sitting, providing a standardized measure of physical activity levels.
Sponsors and contacts
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