Lifestyle Intervention for Pakistani Women in Oslo

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Evaluation of a Lifestyle Intervention to Prevent Type 2 Diabetes/Metabolic Syndrome Among Pakistani Immigrants - Focusing on Changes in Diet and Physical Activity

Conditions
-----------------
Metabolic Syndrome, Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: lifestyle intervention (diet and physical activity)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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 | Behavioral: lifestyle intervention (diet and physical activity)<br>* 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.<br>|
| No Intervention: Control<br>One lesson recieved after post-test | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Fasting Plasma Glucose Value, Baseline |  | baseline | 
| Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline |  | baseline | 
| The Fasting Plasma Glucose, Post-test |  | post-test | 
| Plasma Glucose, 2-h, Post-test |  | post-test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Systolic Blood Pressure, Baseline |  | baseline | 
| Diastolic Blood Pressure, Baseline |  | baseline | 
| Waist Circumference, 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 | 
| Intake of Red Meat, Baseline |  | baseline | 
| Intake of Poultry, Baseline |  | baseline | 
| Intake of Fish, 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lifestyle intervention, Type 2 Diabetes, Metabolic syndrome, Pakistani women, dietary change, Physical activity, Norway