Development and Evaluation of Lifestyle Assessment and Educational Tools for Diabetic People With Limited Literacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in lifestyle knowledge
研究概览
简要总结
Aim: To evaluate a culturally-adapted method of lifestyle assessment, counseling, and education among Arab people with diabetes who have varying literacy skills using an interactive computerized tool and graphically-enhanced patient logs for dietary and physical activity.
The investigators hypothesize that this tool will: a) increase patients' knowledge and understanding of the role of lifestyle (diet and physical activity) in diabetes management; b) improve patients' engagement in monitoring dietary intake and physical activity; c) improve dietary and physical activity behaviors and self-blood glucose monitoring (SBGM) practices; d) improve glycemic control; and, e) improve the efficiency of lifestyle assessment, education and counseling while increasing patients' engagement in the process.
详细描述
Aim: To evaluate a culturally-adapted method of lifestyle assessment, counseling, and education among Arab people with diabetes who have varying literacy skills using an interactive computerized tool and graphically-enhanced patient logs for dietary and physical activity. The investigators will evaluate the effectiveness of this method for: a) increasing patients' knowledge and understanding of the role of lifestyle (diet and physical activity) in diabetes management; b) improving patients' engagement in monitoring dietary intake and physical activity; c) improving dietary and physical activity behaviors and self-blood glucose monitoring (SBGM) practices; d) improving glycaemic control; and, e) improving the efficiency of lifestyle assessment, education and counseling while increasing patients' engagement in the process.
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
- None
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-64 years old
- •BMI 27-45 kg/m2
- •Diagnosis of type 2 diabetes mellitus in medical record
- •HbA1c 8.0%-11.5%
排除标准
- •Short-acting insulin treatment
- •Inadequate control of co-morbid conditions
- •Factors that may limit adherence to interventions (e.g., any medical or physical condition that limits the ability to participate in physical activity or standard diets recommended for people with diabetes, pregnancy, uncontrolled psychiatric condition, significant cognitive impairment, blindness).
结局指标
主要结局
Change in lifestyle knowledge
时间窗: Baseline, 3rd,6th,12th months
Change in diabetes-related lifestyle (diet and physical activity) knowledge, will be assessed with a diet knowledge questionnaire specially adapted for this population. Change in physical activity knowledge will be measured with the SKILLD diabetes knowledge questionnaire.
次要结局
- Dietary and physical activity behaviours(Baseline and 12 months.)
- Glycaemic control(Baseline, 3rd,6th, and 12th months.)
- Patients' lifestyle monitoring(1st,2nd,3rd,6th months)
- Weight and waist circumference(Baseline, 3rd, 6th, and 12th months.)
- SBGM practices(1st, 2nd, 3rd, 6th, 12th months.)
研究者
Ofra Kalter-Leibovici MD
Director of the Unit of Cardiovascular Epidemiology, The Gertner Institute for Epidemiology & Health Policy Research.
Sheba Medical Center