Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425269
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2007-01-19
Brief Title:
Lifestyle Intervention for Pakistani Women in Oslo
Sponsor:
University of Oslo
Organization:
University of Oslo
Study Overview
Official Title:
Evaluation of a Lifestyle Intervention to Prevent Type 2 DiabetesMetabolic Syndrome Among Pakistani Immigrants - Focusing on Changes in Diet and Physical Activity
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InnvaDiab
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
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 dietlifestyle 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 eg 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 groupsThe 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
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 dietlifestyle 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 eg 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 groupsThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-DEPLAN 2004310 | None | None | None |