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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Glycated Hemoglobin (HbA1c)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Video-based lifestyle intervention (own physician) (Behavioral)
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.
干预措施: Video-based lifestyle intervention (unknown physician) (Behavioral)
结局指标
主要结局
Glycated Hemoglobin (HbA1c)
时间窗: 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.
次要结局
- 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)
- Therapeutic Alliance (WAI)(Baseline and 3 months)
- Health-Related Quality of Life (EQ-5D-3L)(Baseline and 3 months)
研究者
Juan F. Lisón Párraga, Dr
Professor
Cardenal Herrera University