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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Holmlia, Oslo
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Oslo, Holmlia, Oslo, Norwegen, 1255
- Primary Health Care Health Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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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Kein Eingriff: Control
One lesson recieved after post-test
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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The Fasting Plasma Glucose Value, Baseline
Zeitfenster: baseline
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baseline
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Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
Zeitfenster: baseline
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baseline
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The Fasting Plasma Glucose, Post-test
Zeitfenster: post-test
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post-test
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Plasma Glucose, 2-h, Post-test
Zeitfenster: post-test
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post-test
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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HbA1c, Baseline
Zeitfenster: baseline
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baseline
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C-peptide, 0-h, Baseline
Zeitfenster: baseline
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baseline
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C-peptid, 2-h, Baseline
Zeitfenster: baseline
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baseline
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Insulin, 0-h, Baseline
Zeitfenster: baseline
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baseline
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Insulin, 2-h, Baseline
Zeitfenster: baseline
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baseline
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High-Density Lipoprotein Cholesterol, Baseline
Zeitfenster: baseline
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baseline
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Triglycerides, Baseline
Zeitfenster: baseline
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baseline
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Systolic Blood Pressure, Baseline
Zeitfenster: baseline
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baseline
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Diastolic Blood Pressure, Baseline
Zeitfenster: baseline
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baseline
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Waist Circumference, Baseline
Zeitfenster: baseline
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baseline
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Body Mass Index, Baseline
Zeitfenster: baseline
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baseline
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Intake of Vegetables, Fruit and Fruit Juice, Baseline
Zeitfenster: baseline
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baseline
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Intake of Soft Drinks With Added Sugar, Baseline
Zeitfenster: baseline
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baseline
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Intake of Red Meat, Baseline
Zeitfenster: baseline
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baseline
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Intake of Poultry, Baseline
Zeitfenster: baseline
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baseline
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Intake of Fish, Baseline
Zeitfenster: baseline
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baseline
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HbA1C, Post-test
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Gerd Holmboe-Ottesen, Dr. Philos., University of Oslo
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NFR 166998/166977
- EU-DEPLAN 2004310
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