Video-Based Lifestyle Counseling in Adults With Type 2 Diabetes.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCardenal Herrera University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Video-based lifestyle intervention (own physician)

    Behavioral

    The 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)

    Behavioral

    The 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

156 Participants
are divided into 2 treatment groups
Group A: Experimental: Own Physician GroupExperimental treatment 1 intervention
Group B: Active Comparator: Unknown Physician GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (pre-intervention) and 3 months (post-intervention)

Secondary outcomes

1

Body Mass Index (BMI)

BMI will be calculated as weight divided by height squared (kg/m²).

Time frame
Baseline and 3 months
2

Blood Pressure (Systolic and Diastolic)

Measured in mmHg following standardized clinical guidelines.

Time frame
Baseline and 3 months
3

Lipid Profile

Total cholesterol, HDL, LDL, and triglycerides (mg/dL).

Time frame
Baseline and 3 months
4

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.

Time frame
Baseline and 3 months

Other outcomes

Sponsors and contacts

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