Improving Physical Activity Levels in the Arabic- Speaking Residents of East Jerusalem With Prediabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 375
- 主要终点
- Physical activity level assessed through average weekly steps
研究概览
简要总结
This three-arm clinical trial aims to improve levels of physical activity among Arabic- speaking residents of East Jerusalem with prediabetes. Levels of daily physical activity (assessed through activity trackers), dietary habits and self-assessed health will be compared between patients that receive only the activity tracker and written information (group A), receive the activity tracker, written information and a personalized physical activity prescription (group B), and those that receive in addition also intensive follow-up with motivational interview by physician assistants and a dietitian (group C)
详细描述
This is a three-arm clinical trial studying the effect of providing activity trackers with intensive motivational interview by trained physician assistants, and dietitian counselling, on the levels of daily physical activity among Arabic- speaking residents of East Jerusalem with prediabetes from Clalit Health Services. In addition, this study will also assess healthy dietary changes, and self assessed health and quality of life.
The study will compare three groups (total 375, each group 125):
Group A - will receive activity trackers and written educational handouts in addition to their usual care.
Group B - will receive all of group A intervention components and also a personalized physical activity prescription.
Group C - will receive all of group B components and also intensive motivational interview support by trained physician assistants (3 sessions), and dietitian support (two sessions).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-diabetes patients - Impaired fasting glucose at least twice between 100-125 mg/dL in the two years prior to the study; or HbA1C 5.7%-6.4% twice in the two years prior to the study; or one test of fasting glucose of 100-125 mg/dL, and one test of HbA1C between 5.7%-6.4% in the two years prior to the study.
排除标准
- •Diabetes including a doctor's diagnosis based on a medical file or a recurrence of fasting blood glucose values above 126 mg/dL in the year preceding the study or a glucose value greater than 200 mg/dL in the year prior to the study or HbA1C above 6.5%
- •Treatment with diabetes drugs other than metformin, as prescribed in the medical file with regular or chronic medications
- •Artificial lower limbs or inability to walk normally (eg: stroke with plegia)
- •Chronic obstructive pulmonary disease
- •Known heart disease (with impaired exercise tolerance)
- •Medical conditions:
- •a cardiac event/ Transient ischemic attack in the last year
- •Cerebrovascular attack with residual impairment
- •Surgery that required hospitalization in the last year
- •Injury to lower limbs that prevents regular walking
- •Malignancy excluding skin cancer small cell carcinoma or basal cell carcinoma
研究组 & 干预措施
Group A
Patients will receive an activity tracker and written information for pre-diabetic, on top of their usual care.
干预措施: Activity tracker plus usual care (Behavioral)
Group B
Patients will receive an activity tracker, written information for pre-diabetic, and personalized physical activity prescription, on top of their usual care.
干预措施: Activity tracker plus usual care (Behavioral)
Group B
Patients will receive an activity tracker, written information for pre-diabetic, and personalized physical activity prescription, on top of their usual care.
干预措施: Personalized physical activity prescription (Behavioral)
Group C
Patients will receive an activity tracker, written information for pre-diabetic, personalized physical activity prescription, three sessions of motivational interview support from trained physician assistants, and two session of dietitian support, on top of their usual care.
干预措施: Motivational Interview support and Dietitian support (Behavioral)
Group C
Patients will receive an activity tracker, written information for pre-diabetic, personalized physical activity prescription, three sessions of motivational interview support from trained physician assistants, and two session of dietitian support, on top of their usual care.
干预措施: Activity tracker plus usual care (Behavioral)
Group C
Patients will receive an activity tracker, written information for pre-diabetic, personalized physical activity prescription, three sessions of motivational interview support from trained physician assistants, and two session of dietitian support, on top of their usual care.
干预措施: Personalized physical activity prescription (Behavioral)
结局指标
主要结局
Physical activity level assessed through average weekly steps
时间窗: six months
次要结局
- Blood pressure(six months)
- Iron intake 0<mg/day<50(six months)
- Fasting glucose levels(six months)
- HbA1C levels(six months)
- Body Mass Index(six months)
- Lipid profile(six months)
- Energy intake 500< kcal/d <6000 kcal/d(Six months)
- Waist circumference(six months)
- Fat intake 15 <gram/day<200(six months)
- Protein intake 10<gram/day<300(six months)
- Vitamin A intake 20< μg RAE/day<2500(six months)
- Vitamin C intake 0<mg/day<2500(six months)
- Folic acid intake 15< μg/day<3000(six months)
研究者
Prof. Amnon Lahad
Director of Medical Quality unit and Chairman department of Family Medicine, Clalit Health Services, Jerusalem district
Clalit Health Services