Lifestyle Intervention for Pakistani Women in Oslo (InnvaDiab)

This study has been completed.
Sponsor:
Collaborators:
European Commission
The Research Council of Norway
Information provided by (Responsible Party):
Gerd Holmboe-Ottesen, University of Oslo
ClinicalTrials.gov Identifier:
NCT00425269
First received: January 19, 2007
Last updated: June 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Type 2 Diabetes
Behavioral: lifestyle intervention (diet and physical activity)

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

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • The Fasting Plasma Glucose Value, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • The Fasting Plasma Glucose, Post-test [ Time Frame: post-test ] [ Designated as safety issue: No ]
  • Plasma Glucose, 2-h, Post-test [ Time Frame: post-test ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • C-peptide, 0-h, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • C-peptid, 2-h, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Insulin, 0-h, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Insulin, 2-h, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • High-Density Lipoprotein Cholesterol, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Triglycerides, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Systolic Blood Pressure, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Diastolic Blood Pressure, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Waist Circumference, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Body Mass Index, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Intake of Vegetables, Fruit and Fruit Juice, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Intake of Soft Drinks With Added Sugar, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Intake of Red Meat, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Intake of Poultry, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Intake of Fish, Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • HbA1C, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • C-peptid, 0-h, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • C-peptid, 2-h, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • Insulin, 0-h, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • Insulin, 2-h, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • High-Density Lipoprotein Cholesterol, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • Triglycerides, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • Systolic Blood Pressure, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • Diastolic Blood Pressure, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • Waist Circumference [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • Body Mass Index, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • Intake of Vegetables, Fruit and Fruit Juice, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • Intake of Soft Drinks With Added Sugar, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • Intake of Red Meat, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • Intake of Poultry, Post-test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]
  • Intake of Fish, Post Test [ Time Frame: post-test, after completion of all six group sessions ] [ Designated as safety issue: No ]

Enrollment: 198
Study Start Date: April 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
No Intervention: Control
One lesson recieved after post-test

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

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425269

Locations
Norway
Primary Health Care Health Center
Oslo, Holmlia, Oslo, Norway, 1255
Sponsors and Collaborators
University of Oslo
European Commission
The Research Council of Norway
Investigators
Principal Investigator: Gerd Holmboe-Ottesen, Dr. Philos. University of Oslo
  More Information

No publications provided

Responsible Party: Gerd Holmboe-Ottesen, PhD, University of Oslo
ClinicalTrials.gov Identifier: NCT00425269     History of Changes
Other Study ID Numbers: NFR 166998/166977, EU-DEPLAN 2004310
Study First Received: January 19, 2007
Results First Received: April 11, 2014
Last Updated: June 24, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Oslo:
lifestyle intervention
Type 2 Diabetes
Metabolic syndrome
Pakistani women
dietary change
Physical activity
Norway

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Metabolic Syndrome X
Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014