Video-Based Lifestyle Counseling in Adults With Type 2 Diabetes.
LIDM2
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
1 other identifier
interventional
156
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Sep 2026
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2026
CompletedFirst Posted
Study publicly available on registry
April 29, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
Study Completion
Last participant's last visit for all outcomes
May 1, 2027
April 29, 2026
April 1, 2026
6 months
April 22, 2026
April 22, 2026
Conditions
Outcome Measures
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.
Baseline (pre-intervention) and 3 months (post-intervention)
Secondary Outcomes (7)
Body Mass Index (BMI)
Baseline and 3 months
Blood Pressure (Systolic and Diastolic)
Baseline and 3 months
Lipid Profile
Baseline and 3 months
Physical Activity Level (IPAQ-SF)
Baseline and 3 months
Adherence to Mediterranean Diet (MEDAS)
Baseline and 3 months
- +2 more secondary outcomes
Study Arms (2)
Experimental: Own Physician Group
EXPERIMENTALParticipants 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.
Active Comparator: Unknown Physician Group
ACTIVE COMPARATORParticipants will receive the same 3 month video-based lifestyle intervention, with identical content delivered by physicians unknown to the participants.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Juan Fco. Lisón. City: Valencia (Spain)
Valencia, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 22, 2026
First Posted
April 29, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04