Efficiency and Cost-effectiveness of a Culturally Adopted Lifestyle Intervention Program - the MEDIM Study. (MEDIM)
28 de septiembre de 2018 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
96
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Skåne
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Malmö, Skåne, Suecia, 20502
- Centre for Primary Health Care Research, Region Skåne and Lund University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
30 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: 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.
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Increased physical activity and improved food habits
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Sin intervención: Controls
Controls have treatment as usual.
Every third month blood tests and a physical exam will be conducted in the control group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body weight
Periodo de tiempo: 4 months
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measured by study nurses
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4 months
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Physical activity
Periodo de tiempo: 4 months
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self-reported
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4 months
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Caloric intake
Periodo de tiempo: 4 month
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from food records
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4 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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QALY
Periodo de tiempo: 4 month
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The effectiveness will be measured as change in health related quality in life measures as Quality adjusted life years (QALY)
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4 month
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Glycemic changes
Periodo de tiempo: 4 month
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fasting glucose, 2-hr glucose
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4 month
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HbA1C
Periodo de tiempo: 4 month
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4 month
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Insulin sensitivity and secretion
Periodo de tiempo: 4 month
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insulin sensitivity index and disposition index
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4 month
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Blood lipid profile
Periodo de tiempo: 4 month
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LDL, HDL, trilycerides
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4 month
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Blood pressure
Periodo de tiempo: 4 month
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systolic and diastolic
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4 month
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Louise Bennet, MD,PhD, Region Skane
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2015
Finalización primaria (Actual)
1 de junio de 2015
Finalización del estudio (Actual)
1 de junio de 2015
Fechas de registro del estudio
Enviado por primera vez
27 de junio de 2011
Primero enviado que cumplió con los criterios de control de calidad
18 de agosto de 2011
Publicado por primera vez (Estimar)
19 de agosto de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de octubre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
28 de septiembre de 2018
Última verificación
1 de septiembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2009/36
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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