Protocol for a Quasi-experimental Controlled Study to Reduce Sedentary Lifestyle in Patients With Type 2 Diabetes

The level of sedentary lifestyle will be measured with the use of accelerometers.

The model used in our study is ActiTrainer.

The level of sedentary lifestyle will be measured with the questionnaire validated in Spanish Sedentary Behavior Questionnaire. This instrument measures the time spent on sedentary behaviors from the moment the person wakes up until they go to bed, performed during weekdays and weekends. Responses are provided on numerical scales, and then the total number of hours dedicated to each activity is summed up. Higher scores indicate more time spent in sedentary activities.

Measured by the Transtheoretical Model of Physical Exercise Change Questionnaire. This questionnaire identifies the stage of the Transtheoretical Model of Change in which a person stands regarding their willingness to engage in physical exercise. It consists of two tables: one for those who do not exercise regularly, with items about reasons for not exercising, and another for those who do, with reasons for exercising. Responses are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The measurement is based on the average scores for each stage of the model. Higher scores indicate a greater readiness to engage in physical activity (better outcome in terms of behavior change).

To measure the level of physical activity, the short, self-administered format of the "International Physical Activity Questionnaire" will be used.

Questions are asked about the time spent on activity over the past 7 days, distinguishing between vigorous activities, walking, or sitting. Results are calculated in minutes per week by multiplying the number of days by the duration of the activity in minutes, obtaining a weekly value for each category. A person is considered inactive if they do not meet the recommended threshold of 150 minutes of moderate physical activity per week. They are classified as sufficiently active if they reach 150 minutes of moderate or 75 minutes of vigorous activity per week, and very active if they exceed 300 minutes of moderate or 150 minutes of vigorous activity per week, as recommended by the WHO.

The validated Spanish version of the Diabetes Quality of Life Questionnaire (DQoL) will be used. Participants rate the items on a 5-point Likert scale, where 1 represents "strongly disagree" and 5 represents "strongly agree." Other items are rated from 1 ("very satisfied") to 5 ("very dissatisfied"). The scores are quantified, with higher scores indicating better quality of life, while lower scores suggest a greater negative impact of diabetes on the patient's life.

Levels of glucose: mg/dL (milligrams per deciliter).

Glycosylated hemoglobin (HbA1c): % (percentage).

Homeostasis model assessment-insulin resistance (HOMA-IR): Dimensionless unit.

Total cholesterol: mg/dL (milligrams per deciliter).

High-density lipoprotein cholesterol (HDL-c): mg/dL (milligrams per deciliter).

Low-density lipoprotein cholesterol (LDL-c): mg/dL (milligrams per deciliter).

Triglycerides (TG): mg/dL (milligrams per deciliter).

Aspartate aminotransferase (AST): U/L (units per liter).

Alanine aminotransferase (ALT): U/L (units per liter).

Gamma-glutamyl transferase (GGT): U/L (units per liter).

Creatinine: mg/dL (milligrams per deciliter).

Urea: mg/dL (milligrams per deciliter.

Creatinine clearance: mL/min (milliliters per minute).

Iron: µg/dL (micrograms per deciliter).

Ferritin: ng/mL (nanograms per milliliter).

Sodium: mmol/L (millimoles per liter).

Potassium: mmol/L (millimoles per liter).

C-reactive protein (CRP): mg/L (milligrams per liter).

Measurements will be taken over the brachial artery, after 5 minutes of rest while seated and with the arms resting at heart level. Long-sleeved shirts will be removed for a correct reading and the cuff size must be adequate.

Anthropometric measurements of weight are collected by healthcare personnel using calibrated instruments and clinical standard procedures. Weight will be measured in kilograms (kg).

Anthropometric measurements of height are collected by healthcare personnel using calibrated instruments and clinical standard procedures. Height will be measured in centimeters (cm).

Weight and height will be combined to report the BMI in kg/m².

Anthropometric measurements of waist-hip circumference are collected by healthcare personnel using calibrated instruments and clinical standard procedures. Waist-hip circumference will be measured in centimeters (cm).