Metabolic Syndrome, Type 2 Diabetes
Conditions
Keywords
lifestyle intervention, Type 2 Diabetes, Metabolic syndrome, Pakistani women, dietary change, Physical activity, Norway
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.
Interventions
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.
Sponsors
European Commission
The Research Council of Norway
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| C-peptid, 2-h, Baseline | baseline |
| 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 |
| HbA1c, Baseline | 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 |
| Intake of Red Meat, Post-test | post-test, after completion of all six group sessions |
| 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 |
| Body Mass Index, Baseline | baseline |
| 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 |
| C-peptide, 0-h, Baseline | baseline |
Countries
Norway
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 101 |
| Control Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests. | 97 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 9 |
| Overall Study | moved or medical reason | 5 | 4 |
| Overall Study | Pregnancy | 5 | 7 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 101 Participants | 97 Participants | 198 Participants |
| Body Mass Index | 29.4 kg/m^2 STANDARD_DEVIATION 5.6 | 29.8 kg/m^2 STANDARD_DEVIATION 5.5 | 29.6 kg/m^2 STANDARD_DEVIATION 5.6 |
| Region of Enrollment Norway | 101 participants | 97 participants | 198 participants |
| Sex: Female, Male Female | 101 Participants | 97 Participants | 198 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Years of education | 9 years STANDARD_DEVIATION 4.7 | 9 years STANDARD_DEVIATION 4.3 | 9 years STANDARD_DEVIATION 4.5 |
| Years of residence in Norway | 18 years STANDARD_DEVIATION 7.9 | 19 years STANDARD_DEVIATION 7.6 | 19 years STANDARD_DEVIATION 7.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline | 8.52 mmol/L |
| Control | Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline | 8.41 mmol/L |
Primary
Plasma Glucose, 2-h, Post-test
Time frame: post-test
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Plasma Glucose, 2-h, Post-test | 8.00 mmol/L |
| Control | Plasma Glucose, 2-h, Post-test | 8.20 mmol/L |
Primary
The Fasting Plasma Glucose, Post-test
Time frame: post-test
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | The Fasting Plasma Glucose, Post-test | 5.39 mmol/L |
| Control | The Fasting Plasma Glucose, Post-test | 5.66 mmol/L |
Primary
The Fasting Plasma Glucose Value, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | The Fasting Plasma Glucose Value, Baseline | 5.55 mmol/L |
| Control | The Fasting Plasma Glucose Value, Baseline | 5.53 mmol/L |
Secondary
Body Mass Index, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Body Mass Index, Baseline | 29.39 kg/m^2 |
| Control | Body Mass Index, Baseline | 29.73 kg/m^2 |
Secondary
Body Mass Index, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Body Mass Index, Post-test | 29.11 kg/m^2 |
| Control | Body Mass Index, Post-test | 29.65 kg/m^2 |
Secondary
C-peptid, 0-h, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | C-peptid, 0-h, Post-test | 878.5 pmol/L |
| Control | C-peptid, 0-h, Post-test | 914.6 pmol/L |
Secondary
C-peptid, 2-h, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | C-peptid, 2-h, Baseline | 3851.5 pmol/L |
| Control | C-peptid, 2-h, Baseline | 3628.9 pmol/L |
Secondary
C-peptid, 2-h, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | C-peptid, 2-h, Post-test | 3618.1 pmol/L |
| Control | C-peptid, 2-h, Post-test | 3439.9 pmol/L |
Secondary
C-peptide, 0-h, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | C-peptide, 0-h, Baseline | 855.0 pmol/L |
| Control | C-peptide, 0-h, Baseline | 839.9 pmol/L |
Secondary
Diastolic Blood Pressure, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Diastolic Blood Pressure, Baseline | 80.0 mmHg |
| Control | Diastolic Blood Pressure, Baseline | 80.8 mmHg |
Secondary
Diastolic Blood Pressure, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Diastolic Blood Pressure, Post-test | 78.6 mmHg |
| Control | Diastolic Blood Pressure, Post-test | 80.1 mmHg |
Secondary
HbA1c, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | HbA1c, Baseline | 5.4 percent of Hb |
| Control | HbA1c, Baseline | 5.4 percent of Hb |
Secondary
HbA1C, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | HbA1C, Post-test | 5.4 percent of Hb |
| Control | HbA1C, Post-test | 5.5 percent of Hb |
Secondary
High-Density Lipoprotein Cholesterol, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | High-Density Lipoprotein Cholesterol, Baseline | 1.26 mmol/L |
| Control | High-Density Lipoprotein Cholesterol, Baseline | 1.25 mmol/L |
Secondary
High-Density Lipoprotein Cholesterol, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | High-Density Lipoprotein Cholesterol, Post-test | 1.24 mmol/L |
| Control | High-Density Lipoprotein Cholesterol, Post-test | 1.20 mmol/L |
Secondary
Insulin, 0-h, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Insulin, 0-h, Baseline | 127.6 pmol/L |
| Control | Insulin, 0-h, Baseline | 116.3 pmol/L |
Secondary
Insulin, 0-h, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Insulin, 0-h, Post-test | 121.8 pmol/L |
| Control | Insulin, 0-h, Post-test | 123.3 pmol/L |
Secondary
Insulin, 2-h, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Insulin, 2-h, Baseline | 931.1 pmol/L |
| Control | Insulin, 2-h, Baseline | 839.5 pmol/L |
Secondary
Insulin, 2-h, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Insulin, 2-h, Post-test | 861.8 pmol/L |
| Control | Insulin, 2-h, Post-test | 786.1 pmol/L |
Secondary
Intake of Fish, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Intake of Fish, Baseline | 0.97 portions/week |
| Control | Intake of Fish, Baseline | 0.77 portions/week |
Secondary
Intake of Fish, Post Test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Intake of Fish, Post Test | 1.13 portions/week |
| Control | Intake of Fish, Post Test | 1.11 portions/week |
Secondary
Intake of Poultry, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Intake of Poultry, Baseline | 2.1 portions/week |
| Control | Intake of Poultry, Baseline | 2.1 portions/week |
Secondary
Intake of Poultry, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Intake of Poultry, Post-test | 1.9 portions/week |
| Control | Intake of Poultry, Post-test | 1.8 portions/week |
Secondary
Intake of Red Meat, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Intake of Red Meat, Baseline | 2.1 portions/week |
| Control | Intake of Red Meat, Baseline | 2.0 portions/week |
Secondary
Intake of Red Meat, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Intake of Red Meat, Post-test | 1.6 portions/week |
| Control | Intake of Red Meat, Post-test | 2.0 portions/week |
Secondary
Intake of Soft Drinks With Added Sugar, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Intake of Soft Drinks With Added Sugar, Baseline | 5.0 dL/week |
| Control | Intake of Soft Drinks With Added Sugar, Baseline | 4.4 dL/week |
Secondary
Intake of Soft Drinks With Added Sugar, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Intake of Soft Drinks With Added Sugar, Post-test | 2.5 dl/week |
| Control | Intake of Soft Drinks With Added Sugar, Post-test | 5.1 dl/week |
Secondary
Intake of Vegetables, Fruit and Fruit Juice, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Intake of Vegetables, Fruit and Fruit Juice, Baseline | 328.9 gram per day |
| Control | Intake of Vegetables, Fruit and Fruit Juice, Baseline | 306.3 gram per day |
Secondary
Intake of Vegetables, Fruit and Fruit Juice, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Intake of Vegetables, Fruit and Fruit Juice, Post-test | 375.4 grams per day |
| Control | Intake of Vegetables, Fruit and Fruit Juice, Post-test | 328.3 grams per day |
Secondary
Systolic Blood Pressure, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Systolic Blood Pressure, Baseline | 115.6 mmHg |
| Control | Systolic Blood Pressure, Baseline | 118.7 mmHg |
Secondary
Systolic Blood Pressure, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Systolic Blood Pressure, Post-test | 114.4 mmHg |
| Control | Systolic Blood Pressure, Post-test | 117.1 mmHg |
Secondary
Triglycerides, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Triglycerides, Baseline | 1.4 mmol/L |
| Control | Triglycerides, Baseline | 1.4 mmol/L |
Secondary
Triglycerides, Post-test
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Triglycerides, Post-test | 1.3 mmol/L |
| Control | Triglycerides, Post-test | 1.5 mmol/L |
Secondary
Waist Circumference
Time frame: post-test, after completion of all six group sessions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Waist Circumference | 95.1 cm |
| Control | Waist Circumference | 96.8 cm |
Secondary
Waist Circumference, Baseline
Time frame: baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Waist Circumference, Baseline | 95.3 cm |
| Control | Waist Circumference, Baseline | 96.2 cm |