Video-Based Lifestyle Counseling in Adults With Type 2 Diabetes.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Video-based lifestyle intervention (own physician), Video-based lifestyle intervention (unknown physician).
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus (Type 2), Glycemic Control for Diabetes Mellitus, Physical Activity, Healthy Eating. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Glycated Hemoglobin (HbA1c) [Time frame: Baseline (pre-intervention) and 3 months (post-intervention)]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Juan Fco. Lisón. City: Valencia (Spain) — Valencia
Identifiers
NCT: NCT07557264 · UNIVERSITY CARDENAL HERRERA101