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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 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: April 7, 2015
Last verified: April 2015
  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.

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.

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.

  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, 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.
  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

Contacts
Contact: louise Bennet, MD, PhD +4640391388 louise.bennet@med.lu.se
Contact: Sonja AC Ruhnke, MSc +46 40 391148 Sonja.Ruhnke@med.lu.se

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
Investigators
Principal Investigator: Louise Bennet, MD,PhD Region Skane
  More Information

Additional Information:
Publications:

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: April 7, 2015
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:
Glucose Intolerance
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases

ClinicalTrials.gov processed this record on August 27, 2015