Diabetes Mellitus (Type 2)LIDM2NCT07557264
Video-Based Lifestyle Counseling in Adults With Type 2 Diabetes.
A study testing Video-based lifestyle intervention (own physician) and Video-based lifestyle intervention (unknown physician) in people with Diabetes Mellitus (Type 2) and Glycemic Control for Diabetes Mellitus, run by Cardenal Herrera University at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus (Type 2), Glycemic Control for Diabetes Mellitus, Physical Activity
- What is being tested?
- Video-based lifestyle intervention (own physician) and Video-based lifestyle intervention (unknown physician)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Physical disability limiting physical activity
- Participation in another structured weight-loss or lifestyle program
- No medical visit in the last 2 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Juan Fco. Lisón. City: Valencia (Spain)
Valencia
Juan Francisco Lisón Párraga, 96 136 90 00 ext. 64540, juanfran@uchceu.es
About this study
Official 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
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.
Read the 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.
- Conditions
- Diabetes Mellitus (Type 2), Glycemic Control for Diabetes Mellitus, Physical Activity, Healthy Eating, Therapeutic Alliance
- Being tested
- Video-based lifestyle intervention (own physician), Video-based lifestyle intervention (unknown physician)
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based lifestyle intervention (own physician)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Own Physician Group | Experimental | 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. Receives: Behavioral: Video-based lifestyle intervention (own physician) |
| Active Comparator: Unknown Physician Group | Active comparator | Participants will receive the same 3 month video-based lifestyle intervention, with identical content delivered by physicians unknown to the participants. Receives: Behavioral: Video-based lifestyle intervention (unknown physician) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-intervention) and 3 months (post-intervention)
Secondary outcomes (7)
Body Mass Index (BMI)
BMI will be calculated as weight divided by height squared (kg/m²).
Measured: Baseline and 3 months
Blood Pressure (Systolic and Diastolic)
Measured in mmHg following standardized clinical guidelines.
Measured: Baseline and 3 months
Lipid Profile
Total cholesterol, HDL, LDL, and triglycerides (mg/dL).
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
Adherence to Mediterranean Diet (MEDAS)
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.
Measured: Baseline and 3 months
Therapeutic Alliance (WAI)
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.
Measured: Baseline and 3 months
Health-Related Quality of Life (EQ-5D-3L)
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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus (Type 2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557264
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA101
- Acronym
- LIDM2
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07557264
- Acronym / sponsor ID
- LIDM2 / UNIVERSITY CARDENAL HERRERA101
- Conditions
- Diabetes Mellitus (Type 2), Glycemic Control for Diabetes Mellitus, Physical Activity, Healthy Eating, Therapeutic Alliance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Own Physician Group | Experimental | Behavioral: Video-based lifestyle intervention (own physician)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. |
| Active Comparator: Unknown Physician Group | Active comparator | Behavioral: Video-based lifestyle intervention (unknown physician)Participants will receive the same 3 month video-based lifestyle intervention, with identical content delivered by physicians unknown to the participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Pregnancy
- Type 1 diabetes or other specific forms of diabetes
- Severe acute or unstable medical condition
- Contraindication to diet or exercise
- Severe psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Experimental: Own Physician Group |
| 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. | Behavioural | Active Comparator: Unknown Physician Group |
Primary outcome
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.
7 secondary outcomes
Body Mass Index (BMI)
Time frame: Baseline and 3 months
Blood Pressure (Systolic and Diastolic)
Time frame: Baseline and 3 months
Lipid Profile
Time frame: Baseline and 3 months
Physical Activity Level (IPAQ-SF)
Time frame: Baseline and 3 months
Adherence to Mediterranean Diet (MEDAS)
Time frame: Baseline and 3 months
Therapeutic Alliance (WAI)
Time frame: Baseline and 3 months
Health-Related Quality of Life (EQ-5D-3L)
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based lifestyle intervention (own physician) and Video-based lifestyle intervention (unknown physician) in people with Diabetes Mellitus (Type 2) and Glycemic Control for Diabetes Mellitus, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Francisco Lisón (+34 96 136 90 00 ext. 64540, juanfran@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Hemoglobin (HbA1c) (time frame: Baseline (pre-intervention) and 3 months (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.