An interventional study of Video-based lifestyle intervention (own physician) and Video-based lifestyle intervention (unknown physician) in Diabetes Mellitus (Type 2), Glycemic Control for Diabetes Mellitus and Physical Activity, sponsored by Cardenal Herrera University. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment
Among 427 studies in Diabetes Mellitus, Type 2 with a site in Spain — 42 open to participants now, 53 under way, 16 of them phase 3. Diabetes Mellitus, Type 2 · Spain.
Among the 427 studies in Diabetes Mellitus, Type 2 with a site in Spain, this one is the 285th largest by planned enrollment of the 381 interventional ones, is one of 22 that started in 2026, is one of 77 with no phase, reaches primary completion later than 22 of the 52 other live ones, and was the 414th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 156 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →42 of the 427 studies in Diabetes Mellitus, Type 2 with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →427 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 22 started in 2026.
Median enrollment 480 across the 381 interventional studies, 842 across the 46 observational. Of the 346 that completed or were terminated, 197 (57%) have results posted.
302 of 427 have an industry lead sponsor. The 10 most frequent:
Cardenal Herrera University is the lead sponsor of 107 studies on the registry; 22 are open to participants now.
Cardenal Herrera University has 3 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
13 of the studies in Diabetes Mellitus, Type 2 with a site in Spain that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT03811561Phase 3Novo Nordisk A/SA Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes | 2027-11-07 |
| NCT03604198Corcept TherapeuticsExtension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | 2026-12 |
| NCT07269015Hospital Mutua de TerrassaCGM Accuracy in Pregnancy Study | 2026-12 |
| NCT06871059University of the Balearic IslandsEffectiveness, Implementation and Spillover Effects of a Culturally Adapted DPP in Spanish Primary Care Centers | 2027-02 |
Among the 427 studies in Diabetes Mellitus, Type 2 with a site in Spain, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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.
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)
Body Mass Index (BMI)
BMI will be calculated as weight divided by height squared (kg/m²).
Time frame: Baseline and 3 months
Blood Pressure (Systolic and Diastolic)
Measured in mmHg following standardized clinical guidelines.
Time frame: Baseline and 3 months
Lipid Profile
Total cholesterol, HDL, LDL, and triglycerides (mg/dL).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 6 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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