Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

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 Malmö): study protocol for a randomized controlled trial

Authors: Sanjib Saha, Matti Leijon, Ulf Gerdtham, Kristina Sundquist, Jan Sundquist, Daniel Arvidsson, Louise Bennet

Published in: Trials | Issue 1/2013

Login to get access

Abstract

Background

Studies have shown that lifestyle interventions are effective in preventing or delaying the onset of type 2 diabetes in high-risk patients. However, research on the effectiveness of lifestyle interventions in high-risk immigrant populations with different cultural and socioeconomic backgrounds is scarce. The aim was to design a culturally adapted lifestyle intervention for an immigrant population and to evaluate its effectiveness and cost-effectiveness.

Methods/design

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.

Discussion

This study will provide a basis to measure the effectiveness of a lifestyle intervention designed for immigrants from the Middle East in terms of improvement in glucose metabolism, and will also assess its cost-effectiveness. Results from this trial may help health care providers and policy makers to adapt and implement lifestyle interventions suitable for this population group that can be conducted in the community.

Trial registration

ClinicalTrials.gov, NCT01420198
Appendix
Available only for authorised users
Literature
1.
Haffner SM, Lehto S, Rönnemaa T, Pyörälä K, Laakso M: Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998, 339: 229-234. 10.1056/NEJM199807233390404.CrossRefPubMed
2.
Writing C, Unwin N, Shaw J, Zimmet P, Alberti KGMM: Impaired glucose tolerance and impaired fasting glycaemia: the current status on definition and intervention. Diabet Med. 2002, 19: 708-723.CrossRef
3.
Zimmet P, Magliano D, Matsuzawa Y, Alberti G, Shaw J: The metabolic syndrome: A global public health problem and a new definition. J Atheroscler Thromb. 2005, 12: 295-300. 10.5551/jat.12.295.CrossRefPubMed
4.
Wild S, Roglic G, Green A, Sicree R, King H: Global prevalence of diabetes. Diabetes Care. 2004, 27: 1047-1053. 10.2337/diacare.27.5.1047.CrossRefPubMed
5.
Wandell PE, Johansson SE, Gafvels C, Hellenius ML, de Faire U, Sundquist J: Estimation of diabetes prevalence among immigrants from the Middle East in Sweden by using three different data sources. Diabetes Metab. 2008, 34: 328-333. 10.1016/j.diabet.2008.01.012.CrossRefPubMed
6.
Wandell PE, Wajngot A, de Faire U, Hellenius ML: Increased prevalence of diabetes among immigrants from non-European countries in 60-year-old men and women in Sweden. Diabetes Metab. 2007, 33: 30-36. 10.1016/j.diabet.2006.07.001.CrossRefPubMed
7.
Bennet L, Johansson S-E, Agardh C-D, Groop L, Sundquist J, Rastam L, Sundquist K: High prevalence of type 2 diabetes in Iraqi and Swedish residents in a deprived Swedish neighbourhood - a population based study. BMC Publ Health. 2011, 11: 303-10.1186/1471-2458-11-303.CrossRef
8.
Glans F, Elgzyri T, Shaat N, Lindholm E, Apelqvist J, Groop L: Immigrants from the Middle-East have a different form of type 2 diabetes compared with Swedish patients. Diabet Med. 2008, 25: 303-307. 10.1111/j.1464-5491.2007.02366.x.CrossRefPubMed
9.
Dela F, von Linstow ME, Mikines KJ, Galbo H: Physical training may enhance beta-cell function in type 2 diabetes. Am J Physiol Endocrinol Metab. 2004, 287: E1024-E1031. 10.1152/ajpendo.00056.2004.CrossRefPubMed
10.
Slentz CA, Tanner CJ, Bateman LA, Durheim MT, Huffman KM, Houmard JA, Kraus WE: Effects of exercise training intensity on pancreatic β-cell function. Diabetes Care. 2009, 32: 1807-1811. 10.2337/dc09-0032.CrossRefPubMedPubMedCentral
11.
Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002, 346: 393-403.
12.
Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M: Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001, 344: 1343-1350. 10.1056/NEJM200105033441801.CrossRefPubMed
13.
Group TDPPR: Costs associated with the primary prevention of type 2 diabetes mellitus in the Diabetes Prevention Program. Diabetes Care. 2003, 26: 36-47.CrossRef
14.
Li G, Zhang P, Wang J, Gregg EW, Yang W, Gong Q, Li H, Li H, Jiang Y, An Y: The long-term effect of lifestyle interventions to prevent diabetes in the China Da Qing Diabetes Prevention Study: a 20-year follow-up study. Lancet. 2008, 371: 1783-1789. 10.1016/S0140-6736(08)60766-7.CrossRefPubMed
15.
Lindström J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemiö K, Hämäläinen H, Härkönen P, Keinänen-Kiukaanniemi S, Laakso M: Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet. 2008, 368: 1673-1679.CrossRef
16.
Diabetes Prevention Program Research G: 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009, 374: 1677-1686. 10.1016/S0140-6736(09)61457-4.CrossRef
17.
Jaber LA, Pinelli NR, Brown MB, Funnell MM, Anderson R, Hammad A, Herman WH: Feasibility of group lifestyle intervention for diabetes prevention in Arab Americans. Diabetes Res Clin Pract. 2011, 91: 307-315. 10.1016/j.diabres.2010.11.032.CrossRefPubMed
18.
Lirussi F: The global challenge of type 2 diabetes and the strategies for response in ethnic minority groups. Diabetes Metab Res Rev. 2010, 26: 421-432. 10.1002/dmrr.1105.CrossRefPubMed
19.
Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stoddart GL: Methods for the Economic Evaluation of Health Care Programmes. 2005, Oxford: Oxford University Press
20.
Hoerger TJ, Hicks KA, Sorensen SW, Herman WH, Ratner RE, Ackermann RT, Zhang P, Engelgau MM: Cost-effectiveness of screening for pre-diabetes among overweight and obese U.S. adults. Diabetes Care. 2007, 30: 2874-2879. 10.2337/dc07-0885.CrossRefPubMed
21.
Lindström J, Tuomilehto J: The diabetes risk score: a practical tool to predict type 2 diabetes risk. Diabetes Care. 2003, 26: 725-731. 10.2337/diacare.26.3.725.CrossRefPubMed
22.
Pinelli NR, Herman WH, Brown MB, Jaber LA: Perceived risk and the willingness to enroll in a diabetes prevention lifestyle intervention in Arab-Americans. Diabetes Res Clin Pract. 2010, 90: e27-e29. 10.1016/j.diabres.2010.08.010.CrossRefPubMedPubMedCentral
23.
Paulweber B, Valensi P, Lindstrom J, Lalic NM, Greaves CJ, McKee M, Kissimova-Skarbek K, Liatis S, Cosson E, Szendroedi J: A European evidence-based guideline for the prevention of type 2 diabetes. Horm Metab Res. 2010, 42 (1): S3-S36.CrossRefPubMed
24.
Lindstrom J, Neumann A, Sheppard KE, Gilis-Januszewska A, Greaves CJ, Handke U, Pajunen P, Puhl S, Polonen A, Rissanen A: Take action to prevent diabetes--the IMAGE toolkit for the prevention of type 2 diabetes in Europe. Horm Metab Res. 2010, 42 (1): S37-S55.CrossRefPubMed
25.
Eriksson KF, Lindgarde F: Prevention of type 2 (non-insulin-dependent) diabetes mellitus by diet and physical exercise. The 6-year Malmo feasibility study. Diabetologia. 1991, 34: 891-898. 10.1007/BF00400196.CrossRefPubMed
26.
Lindström J, Louheranta A, Mannelin M, Rastas M, Salminen V, Eriksson J, Uusitupa M, Tuomilehto J: The Finnish Diabetes Prevention Study (DPS): lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care. 2003, 26: 3230-3236. 10.2337/diacare.26.12.3230.CrossRefPubMed
27.
Kallings LV, Leijon M, Hellénius ML, Ståhle A: Physical activity on prescription in primary health care: a follow-up of physical activity level and quality of life. Scand J Med Sci Sports. 2008, 18: 154-161.CrossRefPubMed
28.
Thorell J, Larson SM: Radioimmunoassay and Related Techniques: Methodology and Clinical Applications. 1978, St louis: The CV Mosby Company
29.
Allain CC, Poon LS, Chan CSG, Richmond W, Fu PC: Enzymatic determination of total serum cholesterol. Clin Chem. 1974, 20: 470-475.PubMed
30.
Friedewald WT, Levy RI, Fredrickson DS: Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972, 18: 499-502.PubMed
31.
von Schenck H, Falkensson M, Lundberg B: Evaluation of "HemoCue," a new device for determining hemoglobin. Clin Chem. 1986, 32: 526-529.PubMed
32.
Matsuda M, DeFronzo RA: Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999, 22: 1462-1470. 10.2337/diacare.22.9.1462.CrossRefPubMed
33.
Hanson RL, Pratley RE, Bogardus C, Narayan KMV, Roumain JML, Imperatore G, Fagot-Campagna A, Pettitt DJ, Bennett PH, Knowler WC: Evaluation of simple indices of insulin sensitivity and insulin secretion for use in epidemioiogic studies. Am J Epidemiol. 2000, 151: 190-198. 10.1093/oxfordjournals.aje.a010187.CrossRefPubMed
34.
Sluiter WJ, Erkelens DW, Reitsma WD, Doorenbos H: Glucose tolerance and insulin release, a mathematical approach: I. Assay of the beta-cell response after oral glucose loading. Diabetes. 1976, 25: 241-244. 10.2337/diabetes.25.4.241.CrossRefPubMed
35.
Bergman RN, Ader M, Huecking K, Van Citters G: Accurate assessment of β-cell function: the hyperbolic correction. Diabetes. 2002, 51: S212-S220. 10.2337/diabetes.51.2007.S212.CrossRefPubMed
36.
van Poppel MNM, Chinapaw MJM, Mokkink LB, van Mechelen W, Terwee CB: Physical activity questionnaires for adults: a systematic review of measurement properties. Sports Med. 2010, 40: 565-600. 10.2165/11531930-000000000-00000. doi.org/10.2165/11531930-000000000-00000CrossRefPubMed
37.
Prince S, Adamo K, Hamel M, Hardt J, Gorber S, Tremblay M: A comparison of direct versus self-report measures for assessing physical activity in adults: a systematic review. Int J Behav Nutr Phys Act. 2008, 5: 56-10.1186/1479-5868-5-56.CrossRefPubMedPubMedCentral
38.
Santos-Lozano A, Marin PJ, Torres-Luque G, Ruiz JR, Lucia A, Garatachea N: Technical variability of the GT3X accelerometer. Med Eng Phys. 2012, 34: 787-790. 10.1016/j.medengphy.2012.02.005.CrossRefPubMed
39.
Santos-Lozano A, Torres-Luque G, Marin PJ, Ruiz JR, Lucia A, Garatachea N: Intermonitor variability of GT3X accelerometer. Int J Sports Med. 2012, 33: 994-999.CrossRefPubMed
40.
Kozey-Keadle S, Libertine A, Lyden K, Staudenmayer J, Freedson PS: Validation of wearable monitors for assessing sedentary behavior. Med Sci Sports Exerc. 2011, 43: 1561-1567. 10.1249/MSS.0b013e31820ce174.CrossRefPubMed
41.
Sasaki JE, John D, Freedson PS: Validation and comparison of ActiGraph activity monitors. J Sci Med Sport. 2011, 14: 411-416. 10.1016/j.jsams.2011.04.003.CrossRefPubMed
42.
Wickel EE, Welk GJ: Applying generalizability theory to estimate habitual activity levels. Med Sci Sports Exerc. 2010, 42: 1528-1534. 10.1249/MSS.0b013e3181d107c4.CrossRefPubMed
43.
Burr JF, Bredin SS, Faktor MD, Warburton DE: The 6-minute walk test as a predictor of objectively measured aerobic fitness in healthy working-aged adults. Phys Sportsmed. 2011, 39: 133-139.CrossRefPubMed
44.
Oja P, Laukkanen R, Pasanen M, Tyry T, Vuori I: A 2-km walking test for assessing the cardiorespiratory fitness of healthy adults. Int J Sports Med. 1991, 12: 356-362. 10.1055/s-2007-1024694.CrossRefPubMed
45.
46.
Agardh E, Moradi T, Allebeck P: The contribution of risk factors to the burden of disease in Sweden. A comparison between Swedish and WHO data. Lakartidningen. 2008, 105: 816-821.PubMed
47.
Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG: The Alcohol Use Disorders Identification Test Guidelines for Use in Primary Care. 2001, Geneva: World Health Organization, Secondth
48.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X: Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011, 20: 1727-1736. 10.1007/s11136-011-9903-x.CrossRefPubMedPubMedCentral
49.
Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983, 67: 361-370. 10.1111/j.1600-0447.1983.tb09716.x.CrossRefPubMed
50.
Bunevicius A, Peceliuniene J, Mickuviene N, Valius L, Bunevicius R: Screening for depression and anxiety disorders in primary care patients. Depress Anxiety. 2007, 24: 455-460. 10.1002/da.20274.CrossRefPubMed
51.
el-Rufaie OE, Absood GH: Retesting the validity of the Arabic version of the Hospital Anxiety and Depression (HAD) scale in primary health care. Soc Psychiatry Psychiatr Epidemiol. 1995, 30: 26-31. 10.1007/BF00784431.CrossRefPubMed
52.
DiClemente CC, Prochaska JO: Self-change and therapy change of smoking behavior: a comparison of processes of change in cessation and maintenance. Addict Behav. 1982, 7: 133-142. 10.1016/0306-4603(82)90038-7.CrossRefPubMed
53.
Norcross JC, Krebs PM, Prochaska JO: Stages of change. J Clin Psychol. 2011, 67: 143-154. 10.1002/jclp.20758.CrossRefPubMed
54.
van Sluijs EM, van Poppel MN, van Mechelen W: Stage-based lifestyle interventions in primary care: are they effective?. Am J Prev Med. 2004, 26: 330-343.CrossRefPubMed
55.
Deci EL, Ryan RM: The" what" and" why" of goal pursuits: human needs and the self-determination of behavior. Psychol Inq. 2000, 11: 227-268. 10.1207/S15327965PLI1104_01.CrossRef
56.
Teixeira PJ, Carraca EV, Markland D, Silva MN, Ryan RM: Exercise, physical activity, and self-determination theory: a systematic review. Int J Behav Nutr Phys Act. 2012, 9: 78-10.1186/1479-5868-9-78.CrossRefPubMedPubMedCentral
57.
Levesque CS, Williams GC, Elliot D, Pickering MA, Bodenhamer B, Finley PJ: Validating the theoretical structure of the Treatment Self-Regulation Questionnaire (TSRQ) across three different health behaviors. Heal Educ Res. 2007, 22: 691-702.CrossRef
58.
59.
Bala MV, Mauskopf JA, Wood LL: Willingness to pay as a measure of health benefits. Pharmacoeconomics. 1999, 15: 9-18. 10.2165/00019053-199915010-00002.CrossRefPubMed
60.
Jacobs N, Drost R, Ament A, Evers S, Claes N: Willingness to pay for a cardiovascular prevention program in highly educated adults: a randomized controlled trial. Int J Technol Assess Health Care. 2011, 27: 283-289. 10.1017/S0266462311000341.CrossRefPubMed
61.
Romé Å, Persson U, Ekdahl C, Gard G: Willingness to pay for health improvements of physical activity on prescription. Scand J Public Health. 2010, 38: 151-159. 10.1177/1403494809357099.CrossRefPubMed
62.
63.
Kalter-Leibovici O, Younis-Zeidan N, Atamna A, Lubin F, Alpert G, Chetrit A, Novikov I, Daoud N, Freedman LS: Lifestyle intervention in obese Arab women: a randomized controlled trial. Arch Intern Med. 2010, 170: 970-976. 10.1001/archinternmed.2010.103.CrossRefPubMed
64.
Glick HA: Sample size and power for cost-effectiveness analysis (Part 2): the effect of maximum willingness to pay. Pharmacoeconomics. 2011, 29: 287-296.CrossRefPubMed
65.
Glick HA: Sample size and power for cost-effectiveness analysis (part 1). Pharmacoeconomics. 2011, 29: 189-198. 10.2165/11585070-000000000-00000.CrossRefPubMed
66.
Sofian M, Omar-Fauzee UPM, Abd-Latif R: The perspective of Arabic Muslim women toward sport participation. J Asia Pacific Studies. 2010, 1: 364-377.
Metadata
Title
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 Malmö): study protocol for a randomized controlled trial
Authors
Sanjib Saha
Matti Leijon
Ulf Gerdtham
Kristina Sundquist
Jan Sundquist
Daniel Arvidsson
Louise Bennet
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-279

Other articles of this Issue 1/2013

Trials 1/2013 Go to the issue

Research

Data sharing among data monitoring committees and responsibilities to patients and science

Study protocol

Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial

Research

Early treatment of posterior crossbite - a randomised clinical trial

Study protocol

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

Study protocol

The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial

Study protocol

Reducing patients’ suicide ideation through training mental health teams in the application of the Dutch multidisciplinary practice guideline on assessment and treatment of suicidal behavior: study protocol of a randomized controlled trial