Evaluation of a Lifestyle Intervention to Prevent Type 2 Diabetes/Metabolic Syndrome Among Pakistani Immigrants - Focusing on Changes in Diet and Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
研究概览
简要总结
Immigrants from South Asia in Norway have a high prevalence of type 2 diabetes and conditions related to the metabolic syndrome. It has been documented that these conditions may be prevented by changes in lifestyle. No previous intervention studies on immigrants with focus on diet and physical activity have been carried out in Norway. This project concerns a randomized controlled trial with intervention to change diet and physical activity in 200 high risk female Pakistani immigrants living in Oslo. The intervention will be evaluated both in terms of outcome and process.
详细描述
Objectives:
- To evaluate the health effects of systematic dietary education and counselling and physical training in a group of Pakistani women with high risk of type 2 diabetes.
- To evaluate the intervention process in order to identify the most effective methods of intervention in regard to diet and physical activity for immigrant women of Pakistani origin.
Background: Immigrants from South Asia have a high prevalence of type 2 diabetes, which may be prevented by intensive on physical activity and diet. This application concerns intervention with diet and physical activity in female (ongoing study) and male (extended study) Pakistani immigrants living in Oslo to reduce their risk for these diseases.
Intervention design: The subjects will be 200 women randomized into an intervention group and a control group (100 in each). The women are being recruited from a township in Oslo with a high proportion of immigrants by using a network approach. Inclusion criteria is based on a risk score developed by Ramachandran et al for Asian Indians, entailing age, Body Mass Index, waist circumference, family history of diabetes and sedentary physical activity.
The intervention will include a combination of individual counselling and group sessions. The intervention group will be divided into subgroups of 10-12 subjects. Each subgroup will have 10 group sessions on diet/lifestyle in the 6 months the intervention period lasts, and will additionally have the possibility to join a cultural adapted exercise program of low intensity twice a week. This includes indoor activities (exercise with music) and outdoor activities (walking groups).
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Risk score developed by Ramachandran et al for Asian Indians:
- •BMI, waist circumference, family history of diabetes and sedentary physical activity
排除标准
- •Type 1 diabetes.
- •Positive auto antibodies.
- •Diagnosis of type 2 diabetes more than 6 months.
- •Medication for type 2 diabetes.
- •Pregnancy at intervention start.
- •Suffering from heart attack or stroke the last 3 months.
- •Already participating in organised physical exercise.
结局指标
主要结局
Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
时间窗: baseline
The Fasting Plasma Glucose, Post-test
时间窗: post-test
Plasma Glucose, 2-h, Post-test
时间窗: post-test
The Fasting Plasma Glucose Value, Baseline
时间窗: baseline
次要结局
- HbA1c, Baseline(baseline)
- C-peptide, 0-h, Baseline(baseline)
- C-peptid, 2-h, Baseline(baseline)
- Insulin, 0-h, Baseline(baseline)
- Insulin, 2-h, Baseline(baseline)
- High-Density Lipoprotein Cholesterol, Baseline(baseline)
- Triglycerides, Baseline(baseline)
- Diastolic Blood Pressure, Baseline(baseline)
- Waist Circumference, Baseline(baseline)
- Systolic Blood Pressure, Baseline(baseline)
- Body Mass Index, Baseline(baseline)
- Intake of Vegetables, Fruit and Fruit Juice, Baseline(baseline)
- Intake of Soft Drinks With Added Sugar, Baseline(baseline)
- HbA1C, Post-test(post-test, after completion of all six group sessions)
- C-peptid, 0-h, Post-test(post-test, after completion of all six group sessions)
- C-peptid, 2-h, Post-test(post-test, after completion of all six group sessions)
- Insulin, 0-h, Post-test(post-test, after completion of all six group sessions)
- Insulin, 2-h, Post-test(post-test, after completion of all six group sessions)
- High-Density Lipoprotein Cholesterol, Post-test(post-test, after completion of all six group sessions)
- Triglycerides, Post-test(post-test, after completion of all six group sessions)
- Systolic Blood Pressure, Post-test(post-test, after completion of all six group sessions)
- Diastolic Blood Pressure, Post-test(post-test, after completion of all six group sessions)
- Intake of Red Meat, Baseline(baseline)
- Intake of Poultry, Baseline(baseline)
- Intake of Fish, Baseline(baseline)
- Waist Circumference(post-test, after completion of all six group sessions)
- Body Mass Index, Post-test(post-test, after completion of all six group sessions)
- Intake of Vegetables, Fruit and Fruit Juice, Post-test(post-test, after completion of all six group sessions)
- Intake of Soft Drinks With Added Sugar, Post-test(post-test, after completion of all six group sessions)
- Intake of Red Meat, Post-test(post-test, after completion of all six group sessions)
- Intake of Poultry, Post-test(post-test, after completion of all six group sessions)
- Intake of Fish, Post Test(post-test, after completion of all six group sessions)
研究者
Gerd Holmboe-Ottesen
PhD
University of Oslo