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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Region Skane
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01420198
First received: June 27, 2011
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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 Intervention
Type 2 Diabetes
Impaired Glucose Tolerance
Obesity
Physical Activity
Behavioral: Lifestyle intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • fasting glucose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    fasting glucose is measured in the fasting state.


Secondary Outcome Measures:
  • QALY [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The effectiveness will be measured as change in health related quality in life measures as Quality adjusted life years (QALY)


Estimated Enrollment: 1244
Study Start Date: July 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • (1) Non-diabetic individuals 30 to 75 years of age, (2) individuals in the baseline survey diagnosed with IGT or IFG + IGT or with a moderate or large diabetes risk (i.e. over 10% risk of diabetes in 10 years measured with FINDRISC scores).

Exclusion Criteria:

  • pregnancy, severe mental illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420198

Locations
Sweden
Centre for Primary Health Care Research, Region Skåne and Lund University Recruiting
Malmö, Skåne, Sweden, 20502
Contact: Louise Bennet, MD PhD    +4640391388    louise.bennet@med.lu.se   
Sponsors and Collaborators
Region Skane
Lund University
  More Information

No publications provided by Region Skane

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01420198     History of Changes
Other Study ID Numbers: 2009/36
Study First Received: June 27, 2011
Last Updated: July 5, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
diabetes type 2
lifestyle intervention
QALY
ethnic group
impaired glucose tolerance
impaired fasting glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperglycemia

ClinicalTrials.gov processed this record on July 29, 2014