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Lifestyle Intervention for Pakistani Women in Oslo (InnvaDiab)

24 giugno 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

198

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

25 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Comportamentale: 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.
Nessun intervento: Control
One lesson recieved after post-test

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
The Fasting Plasma Glucose Value, Baseline
Lasso di tempo: baseline
baseline
Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline
Lasso di tempo: baseline
baseline
The Fasting Plasma Glucose, Post-test
Lasso di tempo: post-test
post-test
Plasma Glucose, 2-h, Post-test
Lasso di tempo: post-test
post-test

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Oslo

Collaboratori

The Research Council of Norway
European Commission

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2006

Completamento primario (Effettivo)

1 settembre 2008

Completamento dello studio (Effettivo)

1 settembre 2008

Date di iscrizione allo studio

Primo inviato

19 gennaio 2007

Primo inviato che soddisfa i criteri di controllo qualità

19 gennaio 2007

Primo Inserito (Stima)

22 gennaio 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

21 luglio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2014

Ultimo verificato

1 aprile 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NFR 166998/166977
  • EU-DEPLAN 2004310

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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