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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Holmlia, Oslo
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Oslo, Holmlia, Oslo, Noruega, 1255
- Primary Health Care Health Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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
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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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Sin intervención: Control
One lesson recieved after post-test
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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The Fasting Plasma Glucose Value, Baseline
Periodo de tiempo: baseline
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baseline
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Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
Periodo de tiempo: baseline
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baseline
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The Fasting Plasma Glucose, Post-test
Periodo de tiempo: post-test
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post-test
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Plasma Glucose, 2-h, Post-test
Periodo de tiempo: post-test
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post-test
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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HbA1c, Baseline
Periodo de tiempo: baseline
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baseline
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C-peptide, 0-h, Baseline
Periodo de tiempo: baseline
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baseline
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C-peptid, 2-h, Baseline
Periodo de tiempo: baseline
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baseline
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Insulin, 0-h, Baseline
Periodo de tiempo: baseline
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baseline
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Insulin, 2-h, Baseline
Periodo de tiempo: baseline
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baseline
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High-Density Lipoprotein Cholesterol, Baseline
Periodo de tiempo: baseline
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baseline
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Triglycerides, Baseline
Periodo de tiempo: baseline
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baseline
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Systolic Blood Pressure, Baseline
Periodo de tiempo: baseline
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baseline
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Diastolic Blood Pressure, Baseline
Periodo de tiempo: baseline
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baseline
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Waist Circumference, Baseline
Periodo de tiempo: baseline
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baseline
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Body Mass Index, Baseline
Periodo de tiempo: baseline
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baseline
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Intake of Vegetables, Fruit and Fruit Juice, Baseline
Periodo de tiempo: baseline
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baseline
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Intake of Soft Drinks With Added Sugar, Baseline
Periodo de tiempo: baseline
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baseline
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Intake of Red Meat, Baseline
Periodo de tiempo: baseline
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baseline
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Intake of Poultry, Baseline
Periodo de tiempo: baseline
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baseline
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Intake of Fish, Baseline
Periodo de tiempo: baseline
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baseline
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HbA1C, Post-test
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gerd Holmboe-Ottesen, Dr. Philos., University of Oslo
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NFR 166998/166977
- EU-DEPLAN 2004310
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