Lifestyle Intervention for Pakistani Women in Oslo (InnvaDiab)
Evaluation of a Lifestyle Intervention to Prevent Type 2 Diabetes/Metabolic Syndrome Among Pakistani Immigrants - Focusing on Changes in Diet and Physical Activity
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Holmlia, Oslo
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Oslo, Holmlia, Oslo, Norsko, 1255
- Primary Health Care Health Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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
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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.
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Žádný zásah: Control
One lesson recieved after post-test
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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The Fasting Plasma Glucose Value, Baseline
Časové okno: baseline
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baseline
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Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
Časové okno: baseline
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baseline
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The Fasting Plasma Glucose, Post-test
Časové okno: post-test
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post-test
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Plasma Glucose, 2-h, Post-test
Časové okno: post-test
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post-test
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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HbA1c, Baseline
Časové okno: baseline
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baseline
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C-peptide, 0-h, Baseline
Časové okno: baseline
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baseline
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C-peptid, 2-h, Baseline
Časové okno: baseline
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baseline
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Insulin, 0-h, Baseline
Časové okno: baseline
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baseline
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Insulin, 2-h, Baseline
Časové okno: baseline
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baseline
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High-Density Lipoprotein Cholesterol, Baseline
Časové okno: baseline
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baseline
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Triglycerides, Baseline
Časové okno: baseline
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baseline
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Systolic Blood Pressure, Baseline
Časové okno: baseline
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baseline
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Diastolic Blood Pressure, Baseline
Časové okno: baseline
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baseline
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Waist Circumference, Baseline
Časové okno: baseline
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baseline
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Body Mass Index, Baseline
Časové okno: baseline
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baseline
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Intake of Vegetables, Fruit and Fruit Juice, Baseline
Časové okno: baseline
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baseline
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Intake of Soft Drinks With Added Sugar, Baseline
Časové okno: baseline
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baseline
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Intake of Red Meat, Baseline
Časové okno: baseline
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baseline
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Intake of Poultry, Baseline
Časové okno: baseline
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baseline
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Intake of Fish, Baseline
Časové okno: baseline
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baseline
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HbA1C, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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C-peptid, 0-h, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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C-peptid, 2-h, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Insulin, 0-h, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Insulin, 2-h, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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High-Density Lipoprotein Cholesterol, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Triglycerides, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Systolic Blood Pressure, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Diastolic Blood Pressure, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Waist Circumference
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Body Mass Index, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Vegetables, Fruit and Fruit Juice, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Soft Drinks With Added Sugar, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Red Meat, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Poultry, Post-test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Intake of Fish, Post Test
Časové okno: post-test, after completion of all six group sessions
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post-test, after completion of all six group sessions
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Gerd Holmboe-Ottesen, Dr. Philos., University of Oslo
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NFR 166998/166977
- EU-DEPLAN 2004310
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