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Lifestyle Intervention for Pakistani Women in Oslo (InnvaDiab)

24. juni 2014 oppdatert av: Gerd Holmboe-Ottesen, University of Oslo

Evaluation of a Lifestyle Intervention to Prevent Type 2 Diabetes/Metabolic Syndrome Among Pakistani Immigrants - Focusing on Changes in Diet and Physical Activity

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

198

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Norge
    • Holmlia, Oslo
      • Oslo, Holmlia, Oslo, Norge, 1255
        • Primary Health Care Health Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

25 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Atferdsmessig: lifestyle intervention (diet and physical activity)
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.
Ingen inngripen: Control
One lesson recieved after post-test

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The Fasting Plasma Glucose Value, Baseline
Tidsramme: baseline
baseline
Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
Tidsramme: baseline
baseline
The Fasting Plasma Glucose, Post-test
Tidsramme: post-test
post-test
Plasma Glucose, 2-h, Post-test
Tidsramme: post-test
post-test

Sekundære resultatmål

Resultatmål
Tidsramme
HbA1c, Baseline
Tidsramme: baseline
baseline
C-peptide, 0-h, Baseline
Tidsramme: baseline
baseline
C-peptid, 2-h, Baseline
Tidsramme: baseline
baseline
Insulin, 0-h, Baseline
Tidsramme: baseline
baseline
Insulin, 2-h, Baseline
Tidsramme: baseline
baseline
High-Density Lipoprotein Cholesterol, Baseline
Tidsramme: baseline
baseline
Triglycerides, Baseline
Tidsramme: baseline
baseline
Systolic Blood Pressure, Baseline
Tidsramme: baseline
baseline
Diastolic Blood Pressure, Baseline
Tidsramme: baseline
baseline
Waist Circumference, Baseline
Tidsramme: baseline
baseline
Body Mass Index, Baseline
Tidsramme: baseline
baseline
Intake of Vegetables, Fruit and Fruit Juice, Baseline
Tidsramme: baseline
baseline
Intake of Soft Drinks With Added Sugar, Baseline
Tidsramme: baseline
baseline
Intake of Red Meat, Baseline
Tidsramme: baseline
baseline
Intake of Poultry, Baseline
Tidsramme: baseline
baseline
Intake of Fish, Baseline
Tidsramme: baseline
baseline
HbA1C, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
C-peptid, 0-h, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
C-peptid, 2-h, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
Insulin, 0-h, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
Insulin, 2-h, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
High-Density Lipoprotein Cholesterol, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
Triglycerides, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
Systolic Blood Pressure, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
Diastolic Blood Pressure, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
Waist Circumference
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
Body Mass Index, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
Intake of Vegetables, Fruit and Fruit Juice, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
Intake of Soft Drinks With Added Sugar, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
Intake of Red Meat, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
Intake of Poultry, Post-test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions
Intake of Fish, Post Test
Tidsramme: post-test, after completion of all six group sessions
post-test, after completion of all six group sessions

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Oslo

Samarbeidspartnere

The Research Council of Norway
European Commission

Etterforskere

  • Hovedetterforsker: Gerd Holmboe-Ottesen, Dr. Philos., University of Oslo

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2006

Primær fullføring (Faktiske)

1. september 2008

Studiet fullført (Faktiske)

1. september 2008

Datoer for studieregistrering

Først innsendt

19. januar 2007

Først innsendt som oppfylte QC-kriteriene

19. januar 2007

Først lagt ut (Anslag)

22. januar 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

21. juli 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juni 2014

Sist bekreftet

1. april 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NFR 166998/166977
  • EU-DEPLAN 2004310

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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