Efficiency and Cost-effectiveness of a Culturally Adopted Lifestyle Intervention Program - the MEDIM Study.

NCT01420198 | Completed

• 1 other identifier: 2009/36
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Impaired Glucose Tolerance; Obesity; Physical Activity

Keywords

Diabetes type 2; Lifestyle intervention; QALY; Ethnic group; Impaired glucose tolerance; Impaired fasting glucose

Outcome Measures

Primary Outcomes (3)

• Body weight

  measured by study nurses

  4 months

• Physical activity

  self-reported

  4 months

• Caloric intake

  from food records

  4 month

Secondary Outcomes (6)

• QALY

  4 month

• Glycemic changes

  4 month

• HbA1C

  4 month

• Insulin sensitivity and secretion

  4 month

• Blood lipid profile

  4 month

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

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.

Behavioral: Lifestyle intervention

Controls

NO INTERVENTION

Controls have treatment as usual. Every third month blood tests and a physical exam will be conducted in the control group.

Interventions

Lifestyle intervention BEHAVIORAL

Increased physical activity and improved food habits

Lifestyle intervention

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Centre for Primary Health Care Research, Region Skåne and Lund University

Malmo, Skåne County, 20502, Sweden

Location

Related Publications (17)

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  PMID: 9698021 BACKGROUND

• 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.

  PMID: 12030390 BACKGROUND

• 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.

  PMID: 12693565 BACKGROUND

• 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.

  PMID: 16810531 BACKGROUND

• 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.

  PMID: 17009065 BACKGROUND

• 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.

  PMID: 16771857 BACKGROUND

• 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.

  PMID: 16729462 BACKGROUND

• 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.

  PMID: 17417955 BACKGROUND

• 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.

  PMID: 19077249 BACKGROUND

• 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.

  PMID: 16462552 BACKGROUND

• 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.

  PMID: 24497980 BACKGROUND

• 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.

  PMID: 24809593 BACKGROUND

• 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.

  PMID: 24472421 BACKGROUND

• 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.

  PMID: 31630098 DERIVED

• 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.

  PMID: 30809646 DERIVED

• 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.

  PMID: 30031454 DERIVED

• 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.

  PMID: 24006857 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Louise Bennet, MD,PhD

  Region Skane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: August 19, 2011
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

SE (1)