Lifestyle Intervention for Pakistani Women in Oslo (InnvaDiab)

• ClinicalTrials.gov Identifier: NCT00425269
• Recruitment Status: Completed
• First Posted: January 22, 2007
• Results First Posted: July 21, 2014
• Last Update Posted: July 21, 2014
• Sponsor: University of Oslo
• Collaborators: European Commission; The Research Council of Norway
• Information provided by (Responsible Party): Gerd Holmboe-Ottesen, University of Oslo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome; Type 2 Diabetes	Behavioral: lifestyle intervention (diet and physical activity)	Not Applicable

Detailed Description:

Objectives:

1. 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.
2. 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Study Start Date: April 2006
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Behavioral: lifestyle intervention (diet and physical activity); 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.
No Intervention: Control; One lesson recieved after post-test

Outcome Measures

Primary Outcome Measures :

1. The Fasting Plasma Glucose Value, Baseline [ Time Frame: baseline ]
2. Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline [ Time Frame: baseline ]
3. The Fasting Plasma Glucose, Post-test [ Time Frame: post-test ]
4. Plasma Glucose, 2-h, Post-test [ Time Frame: post-test ]

Secondary Outcome Measures :

1. HbA1c, Baseline [ Time Frame: baseline ]
2. C-peptide, 0-h, Baseline [ Time Frame: baseline ]
3. C-peptid, 2-h, Baseline [ Time Frame: baseline ]
4. Insulin, 0-h, Baseline [ Time Frame: baseline ]
5. Insulin, 2-h, Baseline [ Time Frame: baseline ]
6. High-Density Lipoprotein Cholesterol, Baseline [ Time Frame: baseline ]
7. Triglycerides, Baseline [ Time Frame: baseline ]
8. Systolic Blood Pressure, Baseline [ Time Frame: baseline ]
9. Diastolic Blood Pressure, Baseline [ Time Frame: baseline ]
10. Waist Circumference, Baseline [ Time Frame: baseline ]
11. Body Mass Index, Baseline [ Time Frame: baseline ]
12. Intake of Vegetables, Fruit and Fruit Juice, Baseline [ Time Frame: baseline ]
13. Intake of Soft Drinks With Added Sugar, Baseline [ Time Frame: baseline ]
14. Intake of Red Meat, Baseline [ Time Frame: baseline ]
15. Intake of Poultry, Baseline [ Time Frame: baseline ]
16. Intake of Fish, Baseline [ Time Frame: baseline ]
17. HbA1C, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
18. C-peptid, 0-h, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
19. C-peptid, 2-h, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
20. Insulin, 0-h, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
21. Insulin, 2-h, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
22. High-Density Lipoprotein Cholesterol, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
23. Triglycerides, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
24. Systolic Blood Pressure, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
25. Diastolic Blood Pressure, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
26. Waist Circumference [ Time Frame: post-test, after completion of all six group sessions ]
27. Body Mass Index, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
28. Intake of Vegetables, Fruit and Fruit Juice, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
29. Intake of Soft Drinks With Added Sugar, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
30. Intake of Red Meat, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
31. Intake of Poultry, Post-test [ Time Frame: post-test, after completion of all six group sessions ]
32. Intake of Fish, Post Test [ Time Frame: post-test, after completion of all six group sessions ]

Eligibility Criteria

• Ages Eligible for Study: 25 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Norway

Primary Health Care Health Center

Oslo, Holmlia, Oslo, Norway, 1255

Sponsors and Collaborators

University of Oslo

European Commission

The Research Council of Norway

Investigators

• Principal Investigator: Gerd Holmboe-Ottesen, Dr. Philos.; University of Oslo

More Information

• Responsible Party: Gerd Holmboe-Ottesen, PhD, University of Oslo
• ClinicalTrials.gov Identifier: NCT00425269
• Other Study ID Numbers: NFR 166998/166977; EU-DEPLAN 2004310
• First Posted: January 22, 2007
• Results First Posted: July 21, 2014
• Last Update Posted: July 21, 2014
• Last Verified: April 2014

Keywords provided by Gerd Holmboe-Ottesen, University of Oslo:

lifestyle intervention; Type 2 Diabetes; Metabolic syndrome; Pakistani women; dietary change; Physical activity; Norway

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism