Effectiveness of a Primary Care Diet and Physical Activity Educational Program for Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Change in Physical activity recommendations (mean)
研究概览
简要总结
An individualized educational intervention are going to be developed. Its based on the COM-B model, designed and applied by Primary Care nursing professionals for patients with type 2 diabetes mellitus. Its expected that participants, after a 6 month intervention, face to face and telephone, will improve their adherence to healthy behaviors related to diet and physical activity, their quality of life and the glycosylated hemoglobin figures.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be cared for by one of the nurses participating in the research team
- •Ability to complete the questionnaire
- •Sign the informed consent
- •Keep the Primary care health center during till the end of the research
排除标准
- 未提供
研究组 & 干预措施
Intervention Group (IG)
- Completing the consent and the pre-intervention questionnaires, anthropometric and HbA1c measurements.
- Dietary and/ or physical activity: face to face plus written material
- 3 months later: motivational phone call.
干预措施: Intervention (Behavioral)
Control group (CG)
- Completing the consent and the pre-intervention questionnaires, anthropometric and HbA1c measurements.
- Usual care
结局指标
主要结局
Change in Physical activity recommendations (mean)
时间窗: Change from Baseline physical activity recommendations at 6 months
Compliance with physical activity recommendations. We are going to use the Motiva.Diaf DM2 questionnaire. Includes 4 questions for physical activity recommendations. Response in dichotomous option 0 (do not follow the recommendation) or 1 (follow the recommendation). Total score range from 0 (worst dietary compliance) to 4 (best dietary compliance). Result: mean number of recommendations followed.
Change in Diet recommendations (mean)
时间窗: Change from Baseline dietary recommendations at 6 months
Compliance with dietary recommendations. We are going to use the Motiva.Diaf DM2 questionnaire. Includes 8 questions for dietary adherence. Response in dichotomous option 0 (do not follow the recommendation) or 1 (follow the recommendation). Total score range from 0 (worst dietary compliance) to 8 (best dietary compliance).
次要结局
- Change in HbA1c (Mean percentage)(Change from Baseline % of HbA1c at 6 months)
研究者
Rubén Martín Payo
Lecturer, Researcher, PhD
University of Oviedo