Video-Based Lifestyle Counseling in Adults With Type 2 Diabetes. (LIDM2)

April 22, 2026 updated by: Juan F. Lisón Párraga, Dr, Cardenal Herrera University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Juan Francisco Lisón
  • Phone Number: 64540 +34 96 136 90 00
  • Email: juanfran@uchceu.es

Study Locations

  • Spain
      • Valencia, Spain
        • Juan Fco. Lisón. City: Valencia (Spain)
        • Contact:
          • Juan Francisco Lisón Párraga
          • Phone Number: 64540 96 136 90 00
          • Email: juanfran@uchceu.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Own Physician Group
Participants will receive a 3-month video-based lifestyle intervention including audiovisual counseling on healthy eating, physical activity, strength training, and psychological strategies. Content will be delivered by the participant's own physician.
Behavioral: Video-based lifestyle intervention (own physician)
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.
Active Comparator: Active Comparator: Unknown Physician Group
Participants will receive the same 3 month video-based lifestyle intervention, with identical content delivered by physicians unknown to the participants.
Behavioral: Video-based lifestyle intervention (unknown physician)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (pre-intervention) and 3 months (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: Baseline and 3 months
BMI will be calculated as weight divided by height squared (kg/m²).
Baseline and 3 months
Blood Pressure (Systolic and Diastolic)
Time Frame: Baseline and 3 months
Measured in mmHg following standardized clinical guidelines.
Baseline and 3 months
Lipid Profile
Time Frame: Baseline and 3 months
Total cholesterol, HDL, LDL, and triglycerides (mg/dL).
Baseline and 3 months
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.
Baseline and 3 months
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.
Baseline and 3 months
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.
Baseline and 3 months
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.
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIVERSITY CARDENAL HERRERA101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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