Lifestyle Intervention for Pakistani Women in Oslo (InnvaDiab)
Evaluation of a Lifestyle Intervention to Prevent Type 2 Diabetes/Metabolic Syndrome Among Pakistani Immigrants - Focusing on Changes in Diet and Physical Activity
研究概览
详细说明
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).
Evaluation: The main end point of the intervention will be the fasting and 2-h plasma glucose value after an oral glucose tolerance test (OGTT). This will be measured at baseline and after 6 months of intervention.
Secondary end-points will be Serum lipid profile (e.g. triglycerides, High-Density Lipoprotein-cholesterol) ; HbA1c ; C-peptide ; serum insulin; serum albumin; body weight; waist and hip circumference; maximum heart rate on treadmill test; self-reported level of intensity, duration and frequency of physical activity; self-reported level of "Stages of change" in regard to motivation and behavioural change; self- reported subjective health complaints; self-reported coping strategies; self-reported sleeping habits.
Dietary information will be collected by 2 x 48 hours dietary recalls. The intake of energy and nutrients will be calculated from the recalls, as well as the intake of food groups.The diet will also be evaluated by a culturally adapted food frequency questionnaire including 20 food groups (with portion sizes). In addition, the use of cooking oils will be registered by questions about the type and quantity oil used per time unit in the household. Additionally, information on knowledge and perceptions on diet and health before and after the intervention will be registered.
Physical activity will be registered using an advanced continuous body monitor, SenseWear Armband yielding information on total energy expenditure, level of intensity, duration and frequency of physical activity, duration of lying down, duration of sleeping, and sleeping quality.
The completion of the questionnaires will take the form of an interview by Urdu speaking staff.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
Holmlia, Oslo
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Oslo、Holmlia, Oslo、挪威、1255
- Primary Health Care Health Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Risk score developed by Ramachandran et al for Asian Indians:
- BMI, waist circumference, family history of diabetes and sedentary physical activity
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Intervention
The intervention group was divided into nine subgroups of ten to twelve women who were offered six educational sessions, each lasting 2 h, during a 7 +- 1-month period.
The main focus was on the physiological importance of blood glucose and its regulation by diet and physical activity, and on knowledge about the Pakistani lifestyle in Pakistan and Norway
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The intervention will include a combination of individual counselling group sessions.
The intervention groups will be divided into subgroups of 10-12 subjects.
Each group 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 culturally adapted exercise program of low intensity twice a week.
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无干预:Control
One lesson recieved after post-test
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
The Fasting Plasma Glucose Value, Baseline
大体时间:baseline
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baseline
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Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
大体时间:baseline
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baseline
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The Fasting Plasma Glucose, Post-test
大体时间:post-test
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post-test
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Plasma Glucose, 2-h, Post-test
大体时间:post-test
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post-test
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次要结果测量
结果测量 |
大体时间 |
---|---|
HbA1c, Baseline
大体时间:baseline
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baseline
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C-peptide, 0-h, Baseline
大体时间:baseline
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baseline
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C-peptid, 2-h, Baseline
大体时间:baseline
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baseline
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Insulin, 0-h, Baseline
大体时间:baseline
|
baseline
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Insulin, 2-h, Baseline
大体时间:baseline
|
baseline
|
High-Density Lipoprotein Cholesterol, Baseline
大体时间:baseline
|
baseline
|
Triglycerides, Baseline
大体时间:baseline
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baseline
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Systolic Blood Pressure, Baseline
大体时间:baseline
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baseline
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Diastolic Blood Pressure, Baseline
大体时间:baseline
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baseline
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Waist Circumference, Baseline
大体时间:baseline
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baseline
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Body Mass Index, Baseline
大体时间:baseline
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baseline
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Intake of Vegetables, Fruit and Fruit Juice, Baseline
大体时间:baseline
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baseline
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Intake of Soft Drinks With Added Sugar, Baseline
大体时间:baseline
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baseline
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Intake of Red Meat, Baseline
大体时间:baseline
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baseline
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Intake of Poultry, Baseline
大体时间:baseline
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baseline
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Intake of Fish, Baseline
大体时间:baseline
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baseline
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HbA1C, Post-test
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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C-peptid, 0-h, Post-test
大体时间:post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
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C-peptid, 2-h, Post-test
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Insulin, 0-h, Post-test
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Insulin, 2-h, Post-test
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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High-Density Lipoprotein Cholesterol, Post-test
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Triglycerides, Post-test
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Systolic Blood Pressure, Post-test
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Diastolic Blood Pressure, Post-test
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Waist Circumference
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
|
Body Mass Index, Post-test
大体时间:post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
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Intake of Vegetables, Fruit and Fruit Juice, Post-test
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Soft Drinks With Added Sugar, Post-test
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Red Meat, Post-test
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
|
Intake of Poultry, Post-test
大体时间:post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Fish, Post Test
大体时间:post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
合作者和调查者
调查人员
- 首席研究员:Gerd Holmboe-Ottesen, Dr. Philos.、University of Oslo
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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代谢综合征的临床试验
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