Metabolic SyndromeInnvaDiabNCT00425269
Lifestyle Intervention for Pakistani Women in Oslo
A study testing lifestyle intervention (diet and physical activity) in people with Metabolic Syndrome and Type 2 Diabetes, run by University of Oslo at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Type 2 Diabetes
- What is being tested?
- lifestyle intervention (diet and physical activity)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2006to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Risk score developed by Ramachandran et al for Asian Indians:
- BMI, waist circumference, family history of diabetes and sedentary physical activity
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Metabolic Syndrome, Type 2 Diabetes
- Being tested
- lifestyle intervention (diet and physical activity)
- Keywords
- lifestyle intervention, Type 2 Diabetes, Metabolic syndrome, Pakistani women, dietary change, Physical activity, Norway
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle intervention (diet and physical activity)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Behavioral: lifestyle intervention (diet and physical activity) |
| Control | No intervention | One lesson recieved after post-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fasting Plasma Glucose Value, Baseline
Measured: baseline
Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
Measured: baseline
The Fasting Plasma Glucose, Post-test
Measured: post-test
Plasma Glucose, 2-h, Post-test
Measured: post-test
Secondary outcomes (32)
HbA1c, Baseline
Measured: baseline
C-peptide, 0-h, Baseline
Measured: baseline
C-peptid, 2-h, Baseline
Measured: baseline
Insulin, 0-h, Baseline
Measured: baseline
Insulin, 2-h, Baseline
Measured: baseline
High-Density Lipoprotein Cholesterol, Baseline
Measured: baseline
Triglycerides, Baseline
Measured: baseline
Systolic Blood Pressure, Baseline
Measured: baseline
Diastolic Blood Pressure, Baseline
Measured: baseline
Waist Circumference, Baseline
Measured: baseline
Body Mass Index, Baseline
Measured: baseline
Intake of Vegetables, Fruit and Fruit Juice, Baseline
Measured: baseline
Intake of Soft Drinks With Added Sugar, Baseline
Measured: baseline
Intake of Red Meat, Baseline
Measured: baseline
Intake of Poultry, Baseline
Measured: baseline
Intake of Fish, Baseline
Measured: baseline
HbA1C, Post-test
Measured: post-test, after completion of all six group sessions
C-peptid, 0-h, Post-test
Measured: post-test, after completion of all six group sessions
C-peptid, 2-h, Post-test
Measured: post-test, after completion of all six group sessions
Insulin, 0-h, Post-test
Measured: post-test, after completion of all six group sessions
Insulin, 2-h, Post-test
Measured: post-test, after completion of all six group sessions
High-Density Lipoprotein Cholesterol, Post-test
Measured: post-test, after completion of all six group sessions
Triglycerides, Post-test
Measured: post-test, after completion of all six group sessions
Systolic Blood Pressure, Post-test
Measured: post-test, after completion of all six group sessions
Diastolic Blood Pressure, Post-test
Measured: post-test, after completion of all six group sessions
Waist Circumference
Measured: post-test, after completion of all six group sessions
Body Mass Index, Post-test
Measured: post-test, after completion of all six group sessions
Intake of Vegetables, Fruit and Fruit Juice, Post-test
Measured: post-test, after completion of all six group sessions
Intake of Soft Drinks With Added Sugar, Post-test
Measured: post-test, after completion of all six group sessions
Intake of Red Meat, Post-test
Measured: post-test, after completion of all six group sessions
Intake of Poultry, Post-test
Measured: post-test, after completion of all six group sessions
Intake of Fish, Post Test
Measured: post-test, after completion of all six group sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startApr 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, The Research Council of Norway
- Responsible party
- Principal investigator, Gerd Holmboe-Ottesen, University of Oslo
- Investigators
- Gerd Holmboe-Ottesen, Dr. Philos., Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425269
- Sponsor's protocol ID
- NFR 166998/166977
- Other IDs
- EU-DEPLAN 2004310
- Acronym
- InnvaDiab
- Status last verified
- Apr 2014
- First submitted
- 19 Jan 2007
- Last updated
- 21 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00425269
- Acronym / sponsor ID
- InnvaDiab / NFR 166998/166977
- Conditions
- Metabolic Syndrome, Type 2 Diabetes
- Keywords
- lifestyle intervention, Type 2 Diabetes, Metabolic syndrome, Pakistani women, dietary change, Physical activity, Norway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- European Commission, The Research Council of Norway
- Study start
- Apr 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 Jan 2007 (estimated)
- Results
- Posted 21 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: lifestyle intervention (diet and physical activity)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 |
| Control | No intervention | –One lesson recieved after post-test |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Risk score developed by Ramachandran et al for Asian Indians:
Key exclusion criteria (7 listed)
- Type 1 diabetes.
- Positive auto antibodies.
- Diagnosis of type 2 diabetes more than 6 months.
- Medication for type 2 diabetes.
- Pregnancy at intervention start.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
Primary outcome
The Fasting Plasma Glucose Value, Baseline
Time frame: baseline
Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
Time frame: baseline
The Fasting Plasma Glucose, Post-test
Time frame: post-test
Plasma Glucose, 2-h, Post-test
Time frame: post-test
32 secondary outcomes
HbA1c, Baseline
Time frame: baseline
C-peptide, 0-h, Baseline
Time frame: baseline
C-peptid, 2-h, Baseline
Time frame: baseline
Insulin, 0-h, Baseline
Time frame: baseline
Insulin, 2-h, Baseline
Time frame: baseline
High-Density Lipoprotein Cholesterol, Baseline
Time frame: baseline
Triglycerides, Baseline
Time frame: baseline
Systolic Blood Pressure, Baseline
Time frame: baseline
Diastolic Blood Pressure, Baseline
Time frame: baseline
Waist Circumference, Baseline
Time frame: baseline
Body Mass Index, Baseline
Time frame: baseline
Intake of Vegetables, Fruit and Fruit Juice, Baseline
Time frame: baseline
Intake of Soft Drinks With Added Sugar, Baseline
Time frame: baseline
Intake of Red Meat, Baseline
Time frame: baseline
Intake of Poultry, Baseline
Time frame: baseline
Intake of Fish, Baseline
Time frame: baseline
HbA1C, Post-test
Time frame: 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
C-peptid, 2-h, Post-test
Time frame: 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
Insulin, 2-h, Post-test
Time frame: 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
Triglycerides, Post-test
Time frame: 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
Diastolic Blood Pressure, Post-test
Time frame: post-test, after completion of all six group sessions
Waist Circumference
Time frame: 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
Intake of Vegetables, Fruit and Fruit Juice, Post-test
Time frame: 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
Intake of Red Meat, Post-test
Time frame: 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
Intake of Fish, Post Test
Time frame: post-test, after completion of all six group sessions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerd Holmboe-Ottesen, Dr. Philos. principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle intervention (diet and physical activity) in people with Metabolic Syndrome and Type 2 Diabetes, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fasting Plasma Glucose Value, Baseline (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.