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NCT Number: NCT07557264

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

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.

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Key information

Conditions

Diabetes Mellitus (Type 2) Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Glycemic Control for Diabetes Mellitus Healthy Eating Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Physical Activity Therapeutic Alliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juan Fco. Lisón. City: Valencia (Spain)

Valencia, Spain

Location contact

Juan Francisco Lisón Párraga

CONTACT

[email protected]

96 136 90 00 ext. 64540

About this study

Type 2 diabetes mellitus (DM2) is a major global public health challenge associated with increased morbidity and mortality. Lifestyle modification is a cornerstone of treatment; however, long-term adherence remains limited. Digital health interventions offer scalable and accessible tools to improve self-management and behavioral change.

This prospective, multicenter, randomized controlled trial will evaluate a video-based lifestyle intervention. A total of 156 adults with DM2 under routine medical follow-up will be recruited from healthcare centers in Sagunto and Castellón (Spain) and randomly assigned (1:1) to one of two parallel groups.

The experimental group will receive the intervention through audiovisual content 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.

Assessments will be conducted at baseline and immediately after the 3 month intervention. Additional follow up assessments are planned at 6 and 12 months. The study explores how extent the physician's identity influences 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Ability to provide informed consent

Exclusion criteria

  • Pregnancy
  • Type 1 diabetes or other specific forms of diabetes
  • Severe acute or unstable medical condition
  • Contraindication to diet or exercise
  • Severe psychiatric disorder
  • Eating disorder
  • Physical disability limiting physical activity
  • Participation in another structured weight-loss or lifestyle program
  • No medical visit in the last 2 years

Treatment and study plan

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.

Primary outcomes

  1. Glycated Hemoglobin (HbA1c)

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

    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

  1. Body Mass Index (BMI)

    Time frame: Baseline and 3 months

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

  2. Blood Pressure (Systolic and Diastolic)

    Time frame: Baseline and 3 months

    Measured in mmHg following standardized clinical guidelines.

  3. Lipid Profile

    Time frame: Baseline and 3 months

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

  4. Physical Activity Level (IPAQ-SF)

    Time frame: Baseline and 3 months

    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.

  5. Adherence to Mediterranean Diet (MEDAS)

    Time frame: Baseline and 3 months

    Adherence to the Mediterranean Diet will be assessed using the MEDAS (Mediterranean Diet Adherence Screener) from the PREDIMED study. This 14-item questionnaire evaluates adherence based on 12 questions about food consumption frequency and 2 questions on dietary habits associated with the Mediterranean diet. Each item is scored 0 or 1 point, with a total possible score ranging from 0 to 14 points. Higher scores indicate greater adherence.

  6. Therapeutic Alliance (WAI)

    Time frame: Baseline and 3 months

    Therapeutic Alliance will be assessed using the Working Alliance Inventory (WAI) questionnaire. This tool evaluates the relationship between a patient and their therapist across three key dimensions: (1) therapeutic goals, (2) tasks, and (3) therapeutic bond. Each item is scored on a Likert scale, with a total possible score ranging from low to high alliance strength. Higher scores indicate a stronger therapeutic alliance, which is associated with better treatment outcomes.

  7. Health-Related Quality of Life (EQ-5D-3L)

    Time frame: Baseline and 3 months

    Health-Related Quality of Life (HRQoL) will be assessed using the EuroQol-5D (EQ-5D) questionnaire. This tool evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a multi-level scale. A health index score will be generated based on these dimensions. The visual analog scale (VAS) will not be used in this study.

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Francisco Lisón

CONTACT

[email protected]

+34 96 136 90 00 ext. 64540

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Effectiveness of a Video-Based Lifestyle Intervention Delivered by Patients' Own Primary Care Physicians Versus an Unfamiliar Physician in Adults With Type 2 Diabetes Mellitus

Acronym: LIDM2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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