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 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Public Health
Published in: BMC Public Health 1/2014

Open Access 01-12-2014 | Study protocol

SLIMMER: a randomised controlled trial of diabetes prevention in Dutch primary health care: design and methods for process, effect, and economic evaluation

Authors: Geerke Duijzer, Annemien Haveman-Nies, Sophia C Jansen, Josien ter Beek, Gerrit J Hiddink, Edith JM Feskens

Published in: BMC Public Health | Issue 1/2014

Login to get access

Abstract

Background

Implementation of interventions in real-life settings requires a comprehensive evaluation approach. The aim of this article is to describe the evaluation design of the SLIMMER diabetes prevention intervention in a Dutch real-life setting.

Methods/Design

The SLIMMER study is a randomised, controlled intervention study including subjects aged 40 through 70 years with impaired fasting glucose or high risk of diabetes. The 10-month SLIMMER intervention involves a dietary and physical activity intervention, including case management and a maintenance programme. The control group receives usual health care and written information about a healthy lifestyle. A logic model of change is composed to link intervention activities with intervention outcomes in a logical order. Primary outcome is fasting insulin. Measurements are performed at baseline and after 12 and 18 months and cover quality of life, cardio-metabolic risk factors (e.g. glucose tolerance, serum lipids, body fatness, and blood pressure), eating and physical activity behaviour, and behavioural determinants. A process evaluation gives insight in how the intervention was delivered and received by participants and health care professionals. The economic evaluation consists of a cost-effectiveness analysis and a cost-utility analysis. Costs are assessed from both a societal and health care perspective.

Discussion

This study is expected to provide insight in the effectiveness, including its cost-effectiveness, and delivery of the SLIMMER diabetes prevention intervention conducted in Dutch primary health care. Results of this study provide valuable information for primary health care professionals, researchers, and policy makers.

Trial registration

The SLIMMER study is registered with ClinicalTrials.gov (NCT02094911) since March 19, 2014.
Appendix
Available only for authorised users
Literature
1.
International Diabetes Federation: IDF Diabetes Atlas sixth edition. 2013
2.
Yoon U, Kwok LL, Magkidis A: Efficacy of lifestyle interventions in reducing diabetes incidence in patients with impaired glucose tolerance: A systematic review of randomized controlled trials. Metab Clin Exp. 2013, 62 (2): 303-314. 10.1016/j.metabol.2012.07.009.CrossRefPubMed
3.
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 (9702): 1677-1686.CrossRef
4.
Lindstrom J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemio K, Hamalainen H, Harkonen P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Mannelin M, Paturi M, Sundvall J, Valle TT, Uusitupa M, Tuomilehto J: Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet. 2006, 368 (9548): 1673-1679. 10.1016/S0140-6736(06)69701-8.CrossRefPubMed
5.
Roumen C, Corpeleijn E, Feskens EJM, Mensink M, Saris WHM, Blaak EE: Impact of 3-year lifestyle intervention on postprandial glucose metabolism: The SLIM study. Diabet Med. 2008, 25 (5): 597-605. 10.1111/j.1464-5491.2008.02417.x.CrossRefPubMed
6.
Garfield SA, Malozowski S, Chin MH, Narayan KMV, Glasgow RE, Green LW, Hiss RG, Krumholz HM: Considerations for diabetes translational research in real-world settings. Diabetes Care. 2003, 26 (9): 2670-2674. 10.2337/diacare.26.9.2670.CrossRefPubMed
7.
Johnson M, Jones R, Freeman C, Woods HB, Gillett M, Goyder E, Payne N: Can diabetes prevention programmes be translated effectively into real-world settings and still deliver improved outcomes? A synthesis of evidence. Diabet Med. 2013, 30 (1): 3-15. 10.1111/dme.12018.CrossRefPubMed
8.
Cardona-Morrell M, Rychetnik L, Morrell SL, Espinel PT, Bauman A: Reduction of diabetes risk in routine clinical practice: Are physical activity and nutrition interventions feasible and are the outcomes from reference trials replicable? A systematic review and meta-analysis. BMC Public Health. 2010, 10: 653-10.1186/1471-2458-10-653.CrossRefPubMedPubMedCentral
9.
10.
Dunkley AJ, Bodicoat DH, Greaves CJ, Russell C, Yates T, Davies MJ, Khunti K: Diabetes prevention in the real world: Effectiveness of pragmatic lifestyle interventions for the prevention of type 2 diabetes and of the impact of adherence to guideline recommendations - A systematic review and meta-analysis. Diabetes Care. 2014, 37 (4): 922-933. 10.2337/dc13-2195.CrossRefPubMed
11.
O'Hara BJ, Bauman AE, Eakin EG, King L, Haas M, Allman-Farinelli M, Owen N, Cardona-Morell M, Farrell L, Milat AJ, Phongsavan P: Evaluation Framework for Translational Research: Case Study of Australia’s Get Healthy Information and Coaching Service®. Health Promot Pract. 2013, 14 (3): 380-389. 10.1177/1524839912456024.CrossRefPubMed
12.
Rychetnik L, Frommer M, Hawe P, Shiell A: Criteria for evaluating evidence on public health interventions. J Epidemiol Community Health. 2002, 56 (2): 119-127. 10.1136/jech.56.2.119.CrossRefPubMedPubMedCentral
13.
Greaves CJ, Sheppard KE, Abraham C, Hardeman W, Roden M, Evans PH, Schwarz P: Systematic review of reviews of intervention components associated with increased effectiveness in dietary and physical activity interventions. BMC Public Health. 2011, 11: 119-10.1186/1471-2458-11-119.CrossRefPubMedPubMedCentral
14.
Vermunt PWA, Milder IEJ, Wielaard F, De Vries JHM, Baan CA, Van Oers JAM, Westert GP: A lifestyle intervention to reduce Type 2 diabetes risk in Dutch primary care: 2.5-year results of a randomized controlled trial. Diabet Med. 2012, 29 (8): e223-e231. 10.1111/j.1464-5491.2012.03648.x.CrossRefPubMed
15.
Lakerveld J, Bot SD, Chinapaw MJ, Van Tulder MW, Kostense PJ, Dekker JM, Nijpels G: Motivational interviewing and problem solving treatment to reduce type 2 diabetes and cardiovascular disease risk in real life: A randomized controlled trial. Int J Behav Nutr Phys Act. 2013, 10: 47-10.1186/1479-5868-10-47.CrossRefPubMedPubMedCentral
16.
Jansen H, Den Engelsen C, Rutten GEHM: Physical activity in patients with metabolic syndrome: At screening and three years thereafter. Metab Syndr Relat Disord. 2013, 11 (3): 163-168. 10.1089/met.2012.0110.CrossRefPubMed
17.
Admiraal WM, Vlaar EM, Nierkens V, Holleman F, Middelkoop BJC, Stronks K, Van Valkengoed IGM: Intensive Lifestyle Intervention in General Practice to Prevent Type 2 Diabetes among 18 to 60-Year-Old South Asians: 1-Year Effects on the Weight Status and Metabolic Profile of Participants in a Randomized Controlled Trial. PLoS ONE. 2013, 8: 7-CrossRef
18.
Jansen SC, Haveman-Nies A, Duijzer G, Ter Beek J, Hiddink GJ, Feskens EJ: Adapting the SLIM diabetes prevention intervention to a Dutch real-life setting: Joint decision making by science and practice. BMC Public Health. 2013, 13: 1-10.1186/1471-2458-13-1.CrossRef
19.
20.
Bartholomew LK, Mullen PD: Five roles for using theory and evidence in the design and testing of behavior change interventions. J Publ Health Dent. 2011, 71 (SUPPL. 1): S20-S33.CrossRef
21.
Michie S, Johnston M, Francis J, Hardeman W, Eccles M: From Theory to Intervention: Mapping Theoretically Derived Behavioural Determinants to Behaviour Change Techniques. Appl Psychol. 2008, 57 (4): 660-680. 10.1111/j.1464-0597.2008.00341.x.CrossRef
22.
Mensink M, Feskens EJM, Saris WHM, De Bruin TWA, Blaak EE: Study on lifestyle intervention and impaired glucose tolerance Maastricht (SLIM): Preliminary results after one year. Int J Obes. 2003, 27 (3): 377-384. 10.1038/sj.ijo.0802249.CrossRef
23.
Littenberg B, MacLean CD: Intra-cluster correlation coefficients in adults with diabetes in primary care practices: The Vermont Diabetes Information System field survey. BMC Med Res Methodol. 2006, 6: 20-10.1186/1471-2288-6-20.CrossRefPubMedPubMedCentral
24.
World Health Organization: Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia: report of a WHO/IDF consultation. 2006, Geneva: World Health Organization
25.
De Weerdt I, Kuipers B, Kok G: ‘Kijk op diabetes’ met perspectief voor de toekomst. 2007, Eindverslag van de eerste fase. In. Amersfoort: Nederlandse Diabetes Federatie
26.
Prochaska JO, Velicer WF: The transtheoretical model of health behavior change. AM J HEALTH PROMOT. 1997, 12 (1): 38-48. 10.4278/0890-1171-12.1.38.CrossRefPubMed
27.
Ajzen I: The theory of planned behavior. Organ Behav Hum Decis Process. 1991, 50 (2): 179-211. 10.1016/0749-5978(91)90020-T.CrossRef
28.
Miller WR, Rollnick S: Motivational interviewing: preparing people to change addictive behaviour. 1991, New York: Guilford Press
29.
Health Council of the Netherlands: Guidelines for a healthy diet 2006. publication no. 2006/21E. The Hague. 2006
30.
Praet SFE, Van Uden C, Hartgens F, Savelberg HHCM, Toereppel K, De Bie RA: KNGF-standaard Beweeginterventie diabetes mellitus type 2 [Royal Dutch Society for Physical Therapy’s guidelines on physical activity intervention type 2 diabetes mellitus]. Amersfoort: Koninklijk Nederlands Genootschap voor Fysiotherapie. 2009
31.
32.
Du H, Van Der ADL, Van Bakel MME, Van Der Kallen CJH, Blaak EE, Van Greevenbroek MMJ, Jansen EHJM, Nijpels G, Stehouwer CDA, Dekker JM, Feskens EJM: Glycemic index and glycemic load in relation to food and nutrient intake and metabolic risk factors in a Dutch population. Am J Clin Nutr. 2008, 87 (3): 655-661.PubMed
33.
Aaronson NK, Muller M, Cohen PDA, Essink-Bot ML, Fekkes M, Sanderman R, Sprangers MAG, Te Velde A, Verrips E: Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998, 51 (11): 1055-1068. 10.1016/S0895-4356(98)00097-3.CrossRefPubMed
34.
Ware JE, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992, 30 (6): 473-483. 10.1097/00005650-199206000-00002.CrossRefPubMed
35.
Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC: Homeostasis model assessment: insulin resistance and β-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985, 28 (7): 412-419. 10.1007/BF00280883.CrossRefPubMed
36.
Crapo RO, Casaburi R, Coates AL, Enright PL, MacIntyre NR, McKay RT, Johnson D, Wanger JS, Zeballos RJ, Bittner V, Mottram C: ATS statement: Guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002, 166 (1): 111-117.CrossRef
37.
Du H, Newton PJ, Salamonson Y, Carrieri-Kohlman VL, Davidson PM: A review of the six-minute walk test: Its implication as a self-administered assessment tool. Eur J Cardiovasc Nurs. 2009, 8 (1): 2-8. 10.1016/j.ejcnurse.2008.07.001.CrossRefPubMed
38.
39.
De Groot LCPGM, Van Staveren WA: Nutrition and the elderly. A European collaborative study in cooperation with the World Health Organization Special Programme for Research on Aging (WHO-SPRA) and the International Union of Nutritional Sciences (IUNS), Committee on Geriatric Nutrition. Manual of Operations, Euronut Report 11. 1988, Wageningen, the Netherlands: EURONUT
40.
Streppel MT, De Vries JH, Meijboom S, Beekman M, De Craen AJ, Slagboom PE, Feskens EJ: Relative validity of the food frequency questionnaire used to assess dietary intake in the Leiden Longevity Study. Nutr J. 2013, 12: 1-10.1186/1475-2891-12-1.CrossRef
41.
Siebelink E, Geelen A, De Vries JHM: Self-reported energy intake by FFQ compared with actual energy intake to maintain body weight in 516 adults. Br J Nutr. 2011, 106 (2): 274-281. 10.1017/S0007114511000067.CrossRefPubMed
42.
Stichting NEVO: Dutch food composition table 2006. The Hague: Netherlands Nutrition Centre. 2006
43.
44.
Wendel-Vos GCW, Schuit AJ, Saris WHM, Kromhout D: Reproducibility and relative validity of the short questionnaire to assess health-enhancing physical activity. J Clin Epidemiol. 2003, 56 (12): 1163-1169. 10.1016/S0895-4356(03)00220-8.CrossRefPubMed
45.
De Hollander EL, Zwart L, De Vries SI, Wendel-Vos W: The SQUASH was a more valid tool than the OBiN for categorizing adults according to the Dutch physical activity and the combined guideline. J Clin Epidemiol. 2012, 65 (1): 73-81. 10.1016/j.jclinepi.2011.05.005.CrossRefPubMed
46.
Chinapaw MJM, Slootmaker SM, Schuit AJ, Van Zuidam M, Van Mechelen W: Reliability and validity of the activity questionnaire for adults and adolescents (AQuAA). BMC Med Res Methodol. 2009, 9: 1-10.1186/1471-2288-9-1.CrossRef
47.
Cane J, O’Connor D, Michie S: Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012, 7: 1-10.1186/1748-5908-7-1.CrossRef
48.
Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A: Making psychological theory useful for implementing evidence based practice: A consensus approach. Qual Saf Health Care. 2005, 14 (1): 26-33. 10.1136/qshc.2004.011155.CrossRefPubMedPubMedCentral
49.
Fishbein M, Ajzen I: Predicting and changing behavior: The reasoned action approach. 2010, New York: Psychology Press
50.
Lakerveld J, Bot SDM, Chinapaw MJM, Knol DL, De Vet HCW, Nijpels G: Measuring pathways towards a healthier lifestyle in the Hoorn Prevention Study: The Determinants of Lifestyle Behavior Questionnaire (DLBQ). Patient Educ Couns. 2011, 85 (2): e53-e58. 10.1016/j.pec.2011.01.014.CrossRefPubMed
51.
Helmink JHM, Van Boekel LC, Kremers SJP: Pilot Beweegkuur overweight and obesity. Results of a follow-up measurement of participants. Pilot BeweegKuur overgewicht & obesitas. Resultaten van een follow-up meting onder deelnemers. 2010, Maastricht: Universiteit Maastricht
52.
Steckler A, Linnan L: Process evaluation for public health interventions and research. 2002, San Francisco: Jossey-Bass
53.
Saunders RP, Evans MH, Joshi P: Developing a process-evaluation plan for assessing health promotion program implementation: a how-to guide. Health Promot Pract. 2005, 6 (2): 134-147. 10.1177/1524839904273387.CrossRefPubMed
54.
Nutbeam D: Evaluating health promotion - progress, problems and solutions. Health Promot Int. 1998, 13 (1): 27-44. 10.1093/heapro/13.1.27.CrossRef
55.
Wang S, Moss JR, Hiller JE: Applicability and transferability of interventions in evidence-based public health. Health Promot Int. 2006, 21 (1): 76-83. Epub 2005 Oct 2025CrossRefPubMed
56.
Brazier J, Roberts J, Deverill M: The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002, 21 (2): 271-292. 10.1016/S0167-6296(01)00130-8.CrossRefPubMed
57.
Brazier J, Usherwood T, Harper R, Thomas K: Deriving a preference-based single index from the UK SF-36 Health Survey. J Clin Epidemiol. 1998, 51 (11): 1115-1128. 10.1016/S0895-4356(98)00103-6.CrossRefPubMed
58.
Hakkaart-van Roijen L, Tan SS, Bouwmans CAM: Handleiding voor kostenonderzoek. Methoden en standaard kostprijzen voor economische evaluaties in de gezondheidszorg. Geactualiseerde versie 2010. Diemen: College voor Zorgverzekeringen. 2010
59.
Tan SS, Bouwmans CAM, Rutten FFH, Hakkaart-Van Roijen L: Update of the dutch manual for costing in economic evaluations. Int J Technol Assess Health Care. 2012, 28 (2): 152-158. 10.1017/S0266462312000062.CrossRefPubMed
60.
Thomas DR: A general inductive approach for analyzing qualitative evaluation data. Am J Eval. 2006, 27 (2): 237-246. 10.1177/1098214005283748.CrossRef
Metadata
Title
SLIMMER: a randomised controlled trial of diabetes prevention in Dutch primary health care: design and methods for process, effect, and economic evaluation
Authors
Geerke Duijzer
Annemien Haveman-Nies
Sophia C Jansen
Josien ter Beek
Gerrit J Hiddink
Edith JM Feskens
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2014
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/1471-2458-14-602

Other articles of this Issue 1/2014

BMC Public Health 1/2014 Go to the issue

Research article

Hand hygiene compliance and associated factors among health care providers in Gondar University Hospital, Gondar, North West Ethiopia

Research article

Which activity monitor to use? Validity, reproducibility and user friendliness of three activity monitors

Research article

Assessment of occupational injuries among Addis Ababa city municipal solid waste collectors: a cross-sectional study

Research article

Violence and reproductive health preceding flight from war: accounts from Somali born women in Sweden

Research article

Tuberculosis among health care workers in KwaZulu-Natal, South Africa: a retrospective cohort analysis

Research article

Beyond BMI: The “Metabolically healthy obese” phenotype & its association with clinical/subclinical cardiovascular disease and all-cause mortality -- a systematic review