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Lifestyle Intervention for Pakistani Women in Oslo (InnvaDiab)

Primary Purpose

Metabolic Syndrome, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
lifestyle intervention (diet and physical activity)
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring lifestyle intervention, Type 2 Diabetes, Metabolic syndrome, Pakistani women, dietary change, Physical activity, Norway

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Primary Health Care Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

One lesson recieved after post-test

Outcomes

Primary Outcome Measures

The Fasting Plasma Glucose Value, Baseline
Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
The Fasting Plasma Glucose, Post-test
Plasma Glucose, 2-h, Post-test

Secondary Outcome Measures

HbA1c, Baseline
C-peptide, 0-h, Baseline
C-peptid, 2-h, Baseline
Insulin, 0-h, Baseline
Insulin, 2-h, Baseline
High-Density Lipoprotein Cholesterol, Baseline
Triglycerides, Baseline
Systolic Blood Pressure, Baseline
Diastolic Blood Pressure, Baseline
Waist Circumference, Baseline
Body Mass Index, Baseline
Intake of Vegetables, Fruit and Fruit Juice, Baseline
Intake of Soft Drinks With Added Sugar, Baseline
Intake of Red Meat, Baseline
Intake of Poultry, Baseline
Intake of Fish, Baseline
HbA1C, Post-test
C-peptid, 0-h, Post-test
C-peptid, 2-h, Post-test
Insulin, 0-h, Post-test
Insulin, 2-h, Post-test
High-Density Lipoprotein Cholesterol, Post-test
Triglycerides, Post-test
Systolic Blood Pressure, Post-test
Diastolic Blood Pressure, Post-test
Waist Circumference
Body Mass Index, Post-test
Intake of Vegetables, Fruit and Fruit Juice, Post-test
Intake of Soft Drinks With Added Sugar, Post-test
Intake of Red Meat, Post-test
Intake of Poultry, Post-test
Intake of Fish, Post Test

Full Information

First Posted
January 19, 2007
Last Updated
June 24, 2014
Sponsor
University of Oslo
Collaborators
European Commission, The Research Council of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT00425269
Brief Title
Lifestyle Intervention for Pakistani Women in Oslo
Acronym
InnvaDiab
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
European Commission, The Research Council of Norway

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Type 2 Diabetes
Keywords
lifestyle intervention, Type 2 Diabetes, Metabolic syndrome, Pakistani women, dietary change, Physical activity, Norway

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
One lesson recieved after post-test
Intervention Type
Behavioral
Intervention Name(s)
lifestyle intervention (diet and physical activity)
Intervention Description
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 Outcome Measure Information:
Title
The Fasting Plasma Glucose Value, Baseline
Time Frame
baseline
Title
Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
Time Frame
baseline
Title
The Fasting Plasma Glucose, Post-test
Time Frame
post-test
Title
Plasma Glucose, 2-h, Post-test
Time Frame
post-test
Secondary Outcome Measure Information:
Title
HbA1c, Baseline
Time Frame
baseline
Title
C-peptide, 0-h, Baseline
Time Frame
baseline
Title
C-peptid, 2-h, Baseline
Time Frame
baseline
Title
Insulin, 0-h, Baseline
Time Frame
baseline
Title
Insulin, 2-h, Baseline
Time Frame
baseline
Title
High-Density Lipoprotein Cholesterol, Baseline
Time Frame
baseline
Title
Triglycerides, Baseline
Time Frame
baseline
Title
Systolic Blood Pressure, Baseline
Time Frame
baseline
Title
Diastolic Blood Pressure, Baseline
Time Frame
baseline
Title
Waist Circumference, Baseline
Time Frame
baseline
Title
Body Mass Index, Baseline
Time Frame
baseline
Title
Intake of Vegetables, Fruit and Fruit Juice, Baseline
Time Frame
baseline
Title
Intake of Soft Drinks With Added Sugar, Baseline
Time Frame
baseline
Title
Intake of Red Meat, Baseline
Time Frame
baseline
Title
Intake of Poultry, Baseline
Time Frame
baseline
Title
Intake of Fish, Baseline
Time Frame
baseline
Title
HbA1C, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
C-peptid, 0-h, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
C-peptid, 2-h, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
Insulin, 0-h, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
Insulin, 2-h, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
High-Density Lipoprotein Cholesterol, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
Triglycerides, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
Systolic Blood Pressure, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
Diastolic Blood Pressure, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
Waist Circumference
Time Frame
post-test, after completion of all six group sessions
Title
Body Mass Index, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
Intake of Vegetables, Fruit and Fruit Juice, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
Intake of Soft Drinks With Added Sugar, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
Intake of Red Meat, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
Intake of Poultry, Post-test
Time Frame
post-test, after completion of all six group sessions
Title
Intake of Fish, Post Test
Time Frame
post-test, after completion of all six group sessions

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerd Holmboe-Ottesen, Dr. Philos.
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Health Care Health Center
City
Oslo
State/Province
Holmlia, Oslo
ZIP/Postal Code
1255
Country
Norway

12. IPD Sharing Statement

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Lifestyle Intervention for Pakistani Women in Oslo

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