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| ID | Type | Description | Link |
|---|---|---|---|
| EU-DEPLAN 2004310 |
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| Name | Class |
|---|---|
| European Commission | OTHER |
| The Research Council of Norway | OTHER |
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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.
Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control | No Intervention | One lesson recieved after post-test |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lifestyle intervention (diet and physical activity) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Fasting Plasma Glucose Value, Baseline | baseline | |
| Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline | baseline | |
| The Fasting Plasma Glucose, Post-test | post-test | |
| Plasma Glucose, 2-h, Post-test | post-test |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c, Baseline | baseline | |
| C-peptide, 0-h, Baseline | baseline | |
| C-peptid, 2-h, Baseline |
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Inclusion Criteria:
Risk score developed by Ramachandran et al for Asian Indians:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerd Holmboe-Ottesen, Dr. Philos. | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Health Care Health Center | Oslo | Holmlia, Oslo | 1255 | Norway |
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A multi-recruitment strategy included visits to mosques and other formal and informal gatherings in the local community, as well as word of mouth. Interested women came to an appointment at the local mother and baby health care centre where the intervention took place. An Urdu-speaking research assistant was in charge of the recruitment
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention. The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants. |
| FG001 | Control | Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Women, aged 18-65 years, more than 50 percent rated their command of the Norwegian language as poor, and mean number of years of education was 9.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention. The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Fasting Plasma Glucose Value, Baseline | Posted | Mean | 95% Confidence Interval | mmol/L | baseline |
|
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serious and/or other [non-serious] adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10-12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention. The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Telle Hjellset | University of Oslo | 0047 22 85 06 12 | t.v.t.hjellset@medisin.uio.no |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
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|
| baseline |
| Insulin, 0-h, Baseline | baseline |
| Insulin, 2-h, Baseline | baseline |
| High-Density Lipoprotein Cholesterol, Baseline | baseline |
| Triglycerides, Baseline | baseline |
| Systolic Blood Pressure, Baseline | baseline |
| Diastolic Blood Pressure, Baseline | baseline |
| Waist Circumference, Baseline | baseline |
| Body Mass Index, Baseline | baseline |
| Intake of Vegetables, Fruit and Fruit Juice, Baseline | baseline |
| Intake of Soft Drinks With Added Sugar, Baseline | baseline |
| Intake of Red Meat, Baseline | baseline |
| Intake of Poultry, Baseline | baseline |
| Intake of Fish, Baseline | baseline |
| HbA1C, Post-test | post-test, after completion of all six group sessions |
| C-peptid, 0-h, Post-test | post-test, after completion of all six group sessions |
| C-peptid, 2-h, Post-test | post-test, after completion of all six group sessions |
| Insulin, 0-h, Post-test | post-test, after completion of all six group sessions |
| Insulin, 2-h, Post-test | post-test, after completion of all six group sessions |
| High-Density Lipoprotein Cholesterol, Post-test | post-test, after completion of all six group sessions |
| Triglycerides, Post-test | post-test, after completion of all six group sessions |
| Systolic Blood Pressure, Post-test | post-test, after completion of all six group sessions |
| Diastolic Blood Pressure, Post-test | post-test, after completion of all six group sessions |
| Waist Circumference | post-test, after completion of all six group sessions |
| Body Mass Index, Post-test | post-test, after completion of all six group sessions |
| Intake of Vegetables, Fruit and Fruit Juice, Post-test | post-test, after completion of all six group sessions |
| Intake of Soft Drinks With Added Sugar, Post-test | post-test, after completion of all six group sessions |
| Intake of Red Meat, Post-test | post-test, after completion of all six group sessions |
| Intake of Poultry, Post-test | post-test, after completion of all six group sessions |
| Intake of Fish, Post Test | post-test, after completion of all six group sessions |
| moved or medical reason |
|
| BG001 | Control | Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years of residence in Norway | Mean | Standard Deviation | years |
|
| Years of education | Mean | Standard Deviation | years |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
|
|
| Primary | Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline | Posted | Mean | 95% Confidence Interval | mmol/L | baseline |
|
|
|
| Secondary | HbA1c, Baseline | Posted | Mean | 95% Confidence Interval | percent of Hb | baseline |
|
|
|
| Secondary | C-peptide, 0-h, Baseline | Posted | Mean | 95% Confidence Interval | pmol/L | baseline |
|
|
|
| Secondary | C-peptid, 2-h, Baseline | Posted | Mean | 95% Confidence Interval | pmol/L | baseline |
|
|
|
| Secondary | Insulin, 0-h, Baseline | Posted | Mean | 95% Confidence Interval | pmol/L | baseline |
|
|
|
| Secondary | Insulin, 2-h, Baseline | Posted | Mean | 95% Confidence Interval | pmol/L | baseline |
|
|
|
| Secondary | High-Density Lipoprotein Cholesterol, Baseline | Posted | Mean | 95% Confidence Interval | mmol/L | baseline |
|
|
|
| Secondary | Triglycerides, Baseline | Posted | Mean | 95% Confidence Interval | mmol/L | baseline |
|
|
|
| Secondary | Systolic Blood Pressure, Baseline | Posted | Mean | 95% Confidence Interval | mmHg | baseline |
|
|
|
| Secondary | Diastolic Blood Pressure, Baseline | Posted | Mean | 95% Confidence Interval | mmHg | baseline |
|
|
|
| Secondary | Waist Circumference, Baseline | Posted | Mean | 95% Confidence Interval | cm | baseline |
|
|
|
| Secondary | Body Mass Index, Baseline | Posted | Mean | 95% Confidence Interval | kg/m^2 | baseline |
|
|
|
| Secondary | Intake of Vegetables, Fruit and Fruit Juice, Baseline | Posted | Mean | Inter-Quartile Range | gram per day | baseline |
|
|
|
| Secondary | Intake of Soft Drinks With Added Sugar, Baseline | Posted | Mean | Inter-Quartile Range | dL/week | baseline |
|
|
|
| Secondary | Intake of Red Meat, Baseline | Posted | Mean | Inter-Quartile Range | portions/week | baseline |
|
|
|
| Secondary | Intake of Poultry, Baseline | Posted | Mean | Inter-Quartile Range | portions/week | baseline |
|
|
|
| Secondary | Intake of Fish, Baseline | Posted | Mean | Inter-Quartile Range | portions/week | baseline |
|
|
|
| Primary | The Fasting Plasma Glucose, Post-test | Posted | Mean | 95% Confidence Interval | mmol/L | post-test |
|
|
|
| Primary | Plasma Glucose, 2-h, Post-test | Posted | Mean | 95% Confidence Interval | mmol/L | post-test |
|
|
|
| Secondary | HbA1C, Post-test | Posted | Mean | 95% Confidence Interval | percent of Hb | post-test, after completion of all six group sessions |
|
|
|
| Secondary | C-peptid, 0-h, Post-test | Posted | Mean | 95% Confidence Interval | pmol/L | post-test, after completion of all six group sessions |
|
|
|
| Secondary | C-peptid, 2-h, Post-test | Posted | Mean | 95% Confidence Interval | pmol/L | post-test, after completion of all six group sessions |
|
|
|
| Secondary | Insulin, 0-h, Post-test | Posted | Mean | 95% Confidence Interval | pmol/L | post-test, after completion of all six group sessions |
|
|
|
| Secondary | Insulin, 2-h, Post-test | Posted | Mean | 95% Confidence Interval | pmol/L | post-test, after completion of all six group sessions |
|
|
|
| Secondary | High-Density Lipoprotein Cholesterol, Post-test | Posted | Mean | 95% Confidence Interval | mmol/L | post-test, after completion of all six group sessions |
|
|
|
| Secondary | Triglycerides, Post-test | Posted | Mean | 95% Confidence Interval | mmol/L | post-test, after completion of all six group sessions |
|
|
|
| Secondary | Systolic Blood Pressure, Post-test | Posted | Mean | 95% Confidence Interval | mmHg | post-test, after completion of all six group sessions |
|
|
|
| Secondary | Diastolic Blood Pressure, Post-test | Posted | Mean | 95% Confidence Interval | mmHg | post-test, after completion of all six group sessions |
|
|
|
| Secondary | Waist Circumference | Posted | Mean | 95% Confidence Interval | cm | post-test, after completion of all six group sessions |
|
|
|
| Secondary | Body Mass Index, Post-test | Posted | Mean | 95% Confidence Interval | kg/m^2 | post-test, after completion of all six group sessions |
|
|
|
| Secondary | Intake of Vegetables, Fruit and Fruit Juice, Post-test | Posted | Mean | Inter-Quartile Range | grams per day | post-test, after completion of all six group sessions |
|
|
|
| Secondary | Intake of Soft Drinks With Added Sugar, Post-test | Posted | Mean | Inter-Quartile Range | dl/week | post-test, after completion of all six group sessions |
|
|
|
| Secondary | Intake of Red Meat, Post-test | Posted | Mean | Inter-Quartile Range | portions/week | post-test, after completion of all six group sessions |
|
|
|
| Secondary | Intake of Poultry, Post-test | Posted | Mean | Inter-Quartile Range | portions/week | post-test, after completion of all six group sessions |
|
|
|
| Secondary | Intake of Fish, Post Test | Posted | Mean | Inter-Quartile Range | portions/week | post-test, after completion of all six group sessions |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control | Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests. | 0 | 0 | 0 | 0 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |