- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00425269
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Holmlia, Oslo
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Oslo, Holmlia, Oslo, Norway, 1255
- Primary Health Care Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Fasting Plasma Glucose Value, Baseline
Time Frame: baseline
|
baseline
|
Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
Time Frame: baseline
|
baseline
|
The Fasting Plasma Glucose, Post-test
Time Frame: post-test
|
post-test
|
Plasma Glucose, 2-h, Post-test
Time Frame: post-test
|
post-test
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c, Baseline
Time Frame: baseline
|
baseline
|
C-peptide, 0-h, Baseline
Time Frame: baseline
|
baseline
|
C-peptid, 2-h, Baseline
Time Frame: baseline
|
baseline
|
Insulin, 0-h, Baseline
Time Frame: baseline
|
baseline
|
Insulin, 2-h, Baseline
Time Frame: baseline
|
baseline
|
High-Density Lipoprotein Cholesterol, Baseline
Time Frame: baseline
|
baseline
|
Triglycerides, Baseline
Time Frame: baseline
|
baseline
|
Systolic Blood Pressure, Baseline
Time Frame: baseline
|
baseline
|
Diastolic Blood Pressure, Baseline
Time Frame: baseline
|
baseline
|
Waist Circumference, Baseline
Time Frame: baseline
|
baseline
|
Body Mass Index, Baseline
Time Frame: baseline
|
baseline
|
Intake of Vegetables, Fruit and Fruit Juice, Baseline
Time Frame: baseline
|
baseline
|
Intake of Soft Drinks With Added Sugar, Baseline
Time Frame: baseline
|
baseline
|
Intake of Red Meat, Baseline
Time Frame: baseline
|
baseline
|
Intake of Poultry, Baseline
Time Frame: baseline
|
baseline
|
Intake of Fish, Baseline
Time Frame: baseline
|
baseline
|
HbA1C, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
C-peptid, 0-h, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
C-peptid, 2-h, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Insulin, 0-h, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Insulin, 2-h, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
High-Density Lipoprotein Cholesterol, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Triglycerides, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Systolic Blood Pressure, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Diastolic Blood Pressure, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Waist Circumference
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Body Mass Index, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Intake of Vegetables, Fruit and Fruit Juice, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Intake of Soft Drinks With Added Sugar, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Intake of Red Meat, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Intake of Poultry, Post-test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Intake of Fish, Post Test
Time Frame: post-test, after completion of all six group sessions
|
post-test, after completion of all six group sessions
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gerd Holmboe-Ottesen, Dr. Philos., University of Oslo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NFR 166998/166977
- EU-DEPLAN 2004310
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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