Clinical trial NCT00425269: Lifestyle Intervention for Pakistani Women in Oslo
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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Type 2 Diabetes
Keywords: lifestyle intervention
Type 2 Diabetes
Metabolic syndrome
Pakistani women
dietary change
Physical activity
Norway
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: European Commission
name: The Research Council of Norway
First posted: 2007-01-22
Enrollment: 198
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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.

Primary outcomes:
measure: The Fasting Plasma Glucose Value, Baseline
timeFrame: baseline
measure: Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
timeFrame: baseline
measure: The Fasting Plasma Glucose, Post-test
timeFrame: post-test
measure: Plasma Glucose, 2-h, Post-test
timeFrame: post-test
Secondary outcomes:
measure: HbA1c, Baseline
timeFrame: baseline
measure: C-peptide, 0-h, Baseline
timeFrame: baseline
measure: C-peptid, 2-h, Baseline
timeFrame: baseline
measure: Insulin, 0-h, Baseline
timeFrame: baseline
measure: Insulin, 2-h, Baseline
timeFrame: baseline
measure: High-Density Lipoprotein Cholesterol, Baseline
timeFrame: baseline
measure: Triglycerides, Baseline
timeFrame: baseline
measure: Systolic Blood Pressure, Baseline
timeFrame: baseline
measure: Diastolic Blood Pressure, Baseline
timeFrame: baseline
measure: Waist Circumference, Baseline
timeFrame: baseline
measure: Body Mass Index, Baseline
timeFrame: baseline
measure: Intake of Vegetables, Fruit and Fruit Juice, Baseline
timeFrame: baseline
measure: Intake of Soft Drinks With Added Sugar, Baseline
timeFrame: baseline
measure: Intake of Red Meat, Baseline
timeFrame: baseline
measure: Intake of Poultry, Baseline
timeFrame: baseline
measure: Intake of Fish, Baseline
timeFrame: baseline
measure: HbA1C, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: C-peptid, 0-h, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: C-peptid, 2-h, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: Insulin, 0-h, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: Insulin, 2-h, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: High-Density Lipoprotein Cholesterol, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: Triglycerides, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: Systolic Blood Pressure, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: Diastolic Blood Pressure, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: Waist Circumference
timeFrame: post-test, after completion of all six group sessions
measure: Body Mass Index, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: Intake of Vegetables, Fruit and Fruit Juice, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: Intake of Soft Drinks With Added Sugar, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: Intake of Red Meat, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: Intake of Poultry, Post-test
timeFrame: post-test, after completion of all six group sessions
measure: Intake of Fish, Post Test
timeFrame: post-test, after completion of all six group sessions
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Primary Health Care Health Center
state: Holmlia, Oslo
Study officials:
affiliation: University of Oslo
name: Gerd Holmboe-Ottesen, Dr. Philos.
role: PRINCIPAL_INVESTIGATOR
References: