Lifestyle Intervention for Pakistani Women in Oslo

Type 2 Diabetes Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425269
• Other study ID #: NFR 166998/166977
• Secondary ID: EU-DEPLAN 200431
• Status: Completed
• Phase: N/A
• First received: January 19, 2007
• Last updated: June 24, 2014
• Start date: April 2006
• Est. completion date: September 2008

Study information

• Verified date: April 2014
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Metabolic Syndrome X
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Norway	Primary Health Care Health Center	Oslo	Holmlia, Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	European Commission, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Fasting Plasma Glucose Value, Baseline		baseline	No
Primary	Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline		baseline	No
Primary	The Fasting Plasma Glucose, Post-test		post-test	No
Primary	Plasma Glucose, 2-h, Post-test		post-test	No
Secondary	HbA1c, Baseline		baseline	No
Secondary	C-peptide, 0-h, Baseline		baseline	No
Secondary	C-peptid, 2-h, Baseline		baseline	No
Secondary	Insulin, 0-h, Baseline		baseline	No
Secondary	Insulin, 2-h, Baseline		baseline	No
Secondary	High-Density Lipoprotein Cholesterol, Baseline		baseline	No
Secondary	Triglycerides, Baseline		baseline	No
Secondary	Systolic Blood Pressure, Baseline		baseline	No
Secondary	Diastolic Blood Pressure, Baseline		baseline	No
Secondary	Waist Circumference, Baseline		baseline	No
Secondary	Body Mass Index, Baseline		baseline	No
Secondary	Intake of Vegetables, Fruit and Fruit Juice, Baseline		baseline	No
Secondary	Intake of Soft Drinks With Added Sugar, Baseline		baseline	No
Secondary	Intake of Red Meat, Baseline		baseline	No
Secondary	Intake of Poultry, Baseline		baseline	No
Secondary	Intake of Fish, Baseline		baseline	No
Secondary	HbA1C, Post-test		post-test, after completion of all six group sessions	No
Secondary	C-peptid, 0-h, Post-test		post-test, after completion of all six group sessions	No
Secondary	C-peptid, 2-h, Post-test		post-test, after completion of all six group sessions	No
Secondary	Insulin, 0-h, Post-test		post-test, after completion of all six group sessions	No
Secondary	Insulin, 2-h, Post-test		post-test, after completion of all six group sessions	No
Secondary	High-Density Lipoprotein Cholesterol, Post-test		post-test, after completion of all six group sessions	No
Secondary	Triglycerides, Post-test		post-test, after completion of all six group sessions	No
Secondary	Systolic Blood Pressure, Post-test		post-test, after completion of all six group sessions	No
Secondary	Diastolic Blood Pressure, Post-test		post-test, after completion of all six group sessions	No
Secondary	Waist Circumference		post-test, after completion of all six group sessions	No
Secondary	Body Mass Index, Post-test		post-test, after completion of all six group sessions	No
Secondary	Intake of Vegetables, Fruit and Fruit Juice, Post-test		post-test, after completion of all six group sessions	No
Secondary	Intake of Soft Drinks With Added Sugar, Post-test		post-test, after completion of all six group sessions	No
Secondary	Intake of Red Meat, Post-test		post-test, after completion of all six group sessions	No
Secondary	Intake of Poultry, Post-test		post-test, after completion of all six group sessions	No
Secondary	Intake of Fish, Post Test		post-test, after completion of all six group sessions	No