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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01420198
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : October 2, 2018
Lund University
Information provided by (Responsible Party):
Region Skane

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Impaired Glucose Tolerance Obesity Physical Activity Behavioral: Lifestyle intervention Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Behavioral: Lifestyle intervention
Increased physical activity and improved food habits

No Intervention: Controls
Controls have treatment as usual. Every third month blood tests and a physical exam will be conducted in the control group.

Primary Outcome Measures :
  1. Body weight [ Time Frame: 4 months ]
    measured by study nurses

  2. Physical activity [ Time Frame: 4 months ]

  3. Caloric intake [ Time Frame: 4 month ]
    from food records

Secondary Outcome Measures :
  1. QALY [ Time Frame: 4 month ]
    The effectiveness will be measured as change in health related quality in life measures as Quality adjusted life years (QALY)

  2. Glycemic changes [ Time Frame: 4 month ]
    fasting glucose, 2-hr glucose

  3. HbA1C [ Time Frame: 4 month ]
  4. Insulin sensitivity and secretion [ Time Frame: 4 month ]
    insulin sensitivity index and disposition index

  5. Blood lipid profile [ Time Frame: 4 month ]
    LDL, HDL, trilycerides

  6. Blood pressure [ Time Frame: 4 month ]
    systolic and diastolic

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420198

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Centre for Primary Health Care Research, Region Skåne and Lund University
Malmö, Skåne, Sweden, 20502
Sponsors and Collaborators
Region Skane
Lund University
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Principal Investigator: Louise Bennet, MD,PhD Region Skane

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01420198    
Other Study ID Numbers: 2009/36
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Keywords provided by Region Skane:
Diabetes type 2
Lifestyle intervention
Ethnic group
Impaired glucose tolerance
Impaired fasting glucose
Additional relevant MeSH terms:
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Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases