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Completed

NCT Number: NCT00425269

Lifestyle Intervention for Pakistani Women in Oslo

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.

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Key information

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Primary Health Care Health Center

Oslo, Holmlia, Oslo, 1255, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lifestyle intervention (diet and physical activity)

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • European Commission
  • The Research Council of Norway

Registry information

Official study title

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

Acronym: InnvaDiab

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 22, 2007
Registry last updated
Jul 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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