Efficiency and Cost-effectiveness of a Culturally Adopted Lifestyle Intervention Program - the MEDIM Study. (MEDIM)
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|ClinicalTrials.gov Identifier: NCT01420198|
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : October 2, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Body weight [ Time Frame: 4 months ]measured by study nurses
- Physical activity [ Time Frame: 4 months ]self-reported
- Caloric intake [ Time Frame: 4 month ]from food records
- 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)
- Glycemic changes [ Time Frame: 4 month ]fasting glucose, 2-hr glucose
- HbA1C [ Time Frame: 4 month ]
- Insulin sensitivity and secretion [ Time Frame: 4 month ]insulin sensitivity index and disposition index
- Blood lipid profile [ Time Frame: 4 month ]LDL, HDL, trilycerides
- Blood pressure [ Time Frame: 4 month ]systolic and diastolic
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
|Centre for Primary Health Care Research, Region Skåne and Lund University|
|Malmö, Skåne, Sweden, 20502|
|Principal Investigator:||Louise Bennet, MD,PhD||Region Skane|