Efficiency and Cost-effectiveness of a Culturally Adopted Lifestyle Intervention Program - the MEDIM Study. (MEDIM)
28. September 2018 aktualisiert von: Region Skane
A Middle Eastern Immigrant Population At-risk for Diabetes; Contributing Risk Factors and the Efficiency and Cost-effectiveness of a Culturally Adopted Lifestyle Intervention Program - the MEDIM Study.
An increasing proportion of Sweden's population comprises non-European immigrants, who constitute a high risk-population for T2D. Numbering almost 9,000 individuals, Iraqi citizens represent the largest immigrant group in Malmoe and are identified as a risk group for Type 2 Diabetes (T2D) in whom genetic and lifestyle factors probably play significant roles in the development of T2D.
Several studies have shown that adoption of an active lifestyle by at-risk individuals dramatically reduces the risk of T2D. However, there are currently no established methods for providing support to high-risk individuals from different cultural and social backgrounds to help them adopt beneficial lasting lifestyle changes. Instead of just waiting for Iraqi high-risk individuals to develop T2D, this project will implement and assess lifestyle intervention programs aimed at reducing the risk of developing T2D and tailored to individuals with a different social and cultural background.
The study thus seeks to optimize preventive action in health care and aims to facilitate the adoption of permanent changes in lifestyle in high-risk patients, taking account of cultural and social barriers.
Since T2D is associated with a sedentary lifestyle and develops earlier in men than women and an average 10 years earlier in immigrants from the Middle East than in native Swedes, it is crucial to study pathogenic mechanisms triggering T2D development in relation to sex, lifestyle and ethnic background. The results will provide the basis for deciding how health care providers can actively work to prevent T2D and other lifestyle-associated diseases in this high-risk population that has not been studied before.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Detaillierte Beschreibung
In this randomized controlled trial, 308 participants (born in Iraq, living in Malmö, Sweden and at high risk of type 2 diabetes) will be allocated to either a culturally adapted intervention or a control group.
The intervention will consist of 10 group counseling sessions focusing on diet, physical activity and behavioral change over 6 months, and the offer of exercise sessions.
Cultural adaptation includes gender-specific exercise sessions, and counseling by a health coach community member.
The control group will receive the information about healthy lifestyle habits provided by the primary health care center.
The primary outcome is change in fasting glucose level.
Secondary outcomes are changes in body mass index, insulin sensitivity,physical activity, food habits and health-related quality of life.
Measurements will be taken at baseline, after 3 and 6 months.
Data will be analyzed by the intention-to-treat approach.
The cost-effectiveness during the trial period and over the longer term will be assessed by simulation modeling from patient, health care and societal perspectives.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
96
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Skåne
-
Malmö, Skåne, Schweden, 20502
- Centre for Primary Health Care Research, Region Skåne and Lund University
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
30 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- (1) 30 to 75 years of age
- (2) individuals in the baseline survey diagnosed with prediabetes. OR BMI ≥ 28 kg/m2 OR waist >=80 cm in females and >=94cm in males.
Exclusion Criteria:
- pregnancy, severe mental illness, diabetes, and/or cognitive impairment, current CVD or history of CVD events. CVD includes stroke, angina or myocardial infarction (MI), percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (CHF), coronary artery bypass graft surgery (CABG), transient ischemic attack (TIA) and peripheral vascular disease (PVD) or other physical disorders that prevent physical exercise.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Lifestyle intervention
Lifestyle intervention: 500 participants from Iraq with obesity and/or prediabetes (impaired fasting glucose) and we expect to recruit 308 participants.
Half of them will be randomized to lifestyle intervention i.e. group counseling and physical activity during a period of 1 year.
An equal amount of controls will have treatment as usual.
Every third month blood tests and a physical exam will be conducted in the intervention group.
|
Increased physical activity and improved food habits
|
|
Kein Eingriff: Controls
Controls have treatment as usual.
Every third month blood tests and a physical exam will be conducted in the control group.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Body weight
Zeitfenster: 4 months
|
measured by study nurses
|
4 months
|
|
Physical activity
Zeitfenster: 4 months
|
self-reported
|
4 months
|
|
Caloric intake
Zeitfenster: 4 month
|
from food records
|
4 month
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
QALY
Zeitfenster: 4 month
|
The effectiveness will be measured as change in health related quality in life measures as Quality adjusted life years (QALY)
|
4 month
|
|
Glycemic changes
Zeitfenster: 4 month
|
fasting glucose, 2-hr glucose
|
4 month
|
|
HbA1C
Zeitfenster: 4 month
|
4 month
|
|
|
Insulin sensitivity and secretion
Zeitfenster: 4 month
|
insulin sensitivity index and disposition index
|
4 month
|
|
Blood lipid profile
Zeitfenster: 4 month
|
LDL, HDL, trilycerides
|
4 month
|
|
Blood pressure
Zeitfenster: 4 month
|
systolic and diastolic
|
4 month
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Louise Bennet, MD,PhD, Region Skåne
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Bennet L, Odeberg H. Resistance to activated protein C, highly prevalent amongst users of oral contraceptives with venous thromboembolism. J Intern Med. 1998 Jul;244(1):27-32. doi: 10.1046/j.1365-2796.1998.00310.x.
- Bennet L, Berglund J. Reinfection with Lyme borreliosis: a retrospective follow-up study in southern Sweden. Scand J Infect Dis. 2002;34(3):183-6. doi: 10.1080/00365540110080070.
- Bennet L, Danell S, Berglund J. Clinical outcome of erythema migrans after treatment with phenoxymethyl penicillin. Scand J Infect Dis. 2003;35(2):129-31. doi: 10.1080/0036554021000027009.
- Bennet L, Halling A, Berglund J. Increased incidence of Lyme borreliosis in southern Sweden following mild winters and during warm, humid summers. Eur J Clin Microbiol Infect Dis. 2006 Jul;25(7):426-32. doi: 10.1007/s10096-006-0167-2.
- Bennet L, Fraenkel CJ, Garpmo U, Halling A, Ingman M, Ornstein K, Stjernberg L, Berglund J. Clinical appearance of erythema migrans caused by Borrelia afzelii and Borrelia garinii--effect of the patient's sex. Wien Klin Wochenschr. 2006 Sep;118(17-18):531-7. doi: 10.1007/s00508-006-0659-1.
- Jarefors S, Bennet L, You E, Forsberg P, Ekerfelt C, Berglund J, Ernerudh J. Lyme borreliosis reinfection: might it be explained by a gender difference in immune response? Immunology. 2006 Jun;118(2):224-32. doi: 10.1111/j.1365-2567.2006.02360.x.
- Bennet L, Stiernstedt S, Berglund J, Hagberg L, Karlsson M, Olsson I, Ornstein K. [Penicillin V is the first choice in the treatment of erythema migrans]. Lakartidningen. 2006 May 3-9;103(18):1454; author reply 1455. No abstract available. Swedish.
- Bennet L, Stjernberg L, Berglund J. Effect of gender on clinical and epidemiologic features of Lyme borreliosis. Vector Borne Zoonotic Dis. 2007 Spring;7(1):34-41. doi: 10.1089/vbz.2006.0533.
- Ingelsson E, Bennet L, Ridderstrale M, Soderstrom M, Rastam L, Lindblad U. The PPARGC1A Gly482Ser polymorphism is associated with left ventricular diastolic dysfunction in men. BMC Cardiovasc Disord. 2008 Dec 11;8:37. doi: 10.1186/1471-2261-8-37.
- Leao TS, Sundquist J, Frank G, Johansson LM, Johansson SE, Sundquist K. Incidence of schizophrenia or other psychoses in first- and second-generation immigrants: a national cohort study. J Nerv Ment Dis. 2006 Jan;194(1):27-33. doi: 10.1097/01.nmd.0000195312.81334.81.
- Wang X, Sundquist J, Zoller B, Memon AA, Palmer K, Sundquist K, Bennet L. Determination of 14 circulating microRNAs in Swedes and Iraqis with and without diabetes mellitus type 2. PLoS One. 2014 Jan 30;9(1):e86792. doi: 10.1371/journal.pone.0086792. eCollection 2014.
- Arvidsson D, Lindblad U, Sundquist J, Sundquist K, Groop L, Bennet L. Vigorous physical activity may be important for the insulin sensitivity in immigrants from the Middle East and native Swedes. J Phys Act Health. 2015 Feb;12(2):273-81. doi: 10.1123/jpah.2013-0222. Epub 2014 May 6.
- Bennet L, Groop L, Lindblad U, Agardh CD, Franks PW. Ethnicity is an independent risk indicator when estimating diabetes risk with FINDRISC scores: a cross sectional study comparing immigrants from the Middle East and native Swedes. Prim Care Diabetes. 2014 Oct;8(3):231-8. doi: 10.1016/j.pcd.2014.01.002. Epub 2014 Jan 25.
- Olaya-Contreras P, Balcker-Lundgren K, Siddiqui F, Bennet L. Perceptions, experiences and barriers to lifestyle modifications in first-generation Middle Eastern immigrants to Sweden: a qualitative study. BMJ Open. 2019 Oct 19;9(10):e028076. doi: 10.1136/bmjopen-2018-028076.
- Siddiqui F, Lindblad U, Nilsson PM, Bennet L. Effects of a randomized, culturally adapted, lifestyle intervention on mental health among Middle-Eastern immigrants. Eur J Public Health. 2019 Oct 1;29(5):888-894. doi: 10.1093/eurpub/ckz020.
- Siddiqui F, Koivula RW, Kurbasic A, Lindblad U, Nilsson PM, Bennet L. Physical Activity in a Randomized Culturally Adapted Lifestyle Intervention. Am J Prev Med. 2018 Aug;55(2):187-196. doi: 10.1016/j.amepre.2018.04.016.
- Saha S, Leijon M, Gerdtham U, Sundquist K, Sundquist J, Arvidsson D, Bennet L. A culturally adapted lifestyle intervention addressing a Middle Eastern immigrant population at risk of diabetes, the MEDIM (impact of Migration and Ethnicity on Diabetes In Malmo): study protocol for a randomized controlled trial. Trials. 2013 Sep 3;14:279. doi: 10.1186/1745-6215-14-279.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2015
Primärer Abschluss (Tatsächlich)
1. Juni 2015
Studienabschluss (Tatsächlich)
1. Juni 2015
Studienanmeldedaten
Zuerst eingereicht
27. Juni 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. August 2011
Zuerst gepostet (Schätzen)
19. August 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
2. Oktober 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. September 2018
Zuletzt verifiziert
1. September 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2009/36
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Lifestyle intervention
-
University of FloridaAbgeschlossenEmpfindlichkeitVereinigte Staaten
-
Case Western Reserve UniversityAmerican UniversityNoch keine RekrutierungErnährung, gesund
-
Thomas Jefferson UniversityRekrutierungProstatakarzinomVereinigte Staaten
-
Rabin Medical CenterAcademic College of Tel Aviv-Jaffa; Israel Cancer AssociationUnbekanntEierstockkrebs | Krebs des Gebärmutterhalses | Krebs des EndometriumsIsrael
-
University of Kansas Medical CenterAbgeschlossen
-
Biolux Research Holdings, Inc.BeendetKieferorthopädische ZahnbewegungKanada
-
University of WashingtonNational Cancer Institute (NCI)AbgeschlossenMelanom | Lymphom | Gebärmutterhalskrebs | Leukämie | Brustkrebs | Darmkrebs | Darmkrebs | Bösartige NeubildungVereinigte Staaten
-
German Institute of Human NutritionBeneo GmbHAbgeschlossenDiabetes mellitus, Typ 2 | Metabolisches SyndromDeutschland
-
University MariborAktiv, nicht rekrutierendHerzkrankheiten | Herz-Kreislauf-Erkrankungen | Koronare Herzkrankheit | Koronare Herzerkrankung | Lebensstil | Kontinuierliche Glukoseüberwachung | Verhaltensänderung | CGM | Visuelle AnalyseSlowenien
-
Ohio State University Comprehensive Cancer CenterAbgeschlossenHumanes Papillomavirus-assoziiertes KarzinomVereinigte Staaten