Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes mellitus: study protocol of myDIDeA

Amutha Ramadas, Kia Fatt Quek, Carina K Y Chan, Brian Oldenburg, Zanariah Hussein, Amutha Ramadas, Kia Fatt Quek, Carina K Y Chan, Brian Oldenburg, Zanariah Hussein

Abstract

Background: The potential of web-based interventions in dietary behaviour modification of the diabetics has not been fully explored. We describe the protocol of a 12-month match-design randomised controlled trial of a web-based dietary intervention for type 2 diabetic patients with primary aim to evaluate the effect of the intervention on their dietary knowledge, attitude and behaviour (KAB). The secondary objective of this study is to improve the participants' dietary practices, physical measurements and biomarkers.

Methods/design: A minimum total sample of 82 Type 2 diabetics will be randomised, either to the control group, who will receive the standard diabetes care or the e-intervention group, who will participate in a 6-month web-based dietary intervention in addition to the standard care. The dietary recommendations are based on existing guidelines, but personalised according to the patients' Stages of Change (SOC). The participants will be followed up for 6 months post-intervention with data collection scheduled at baseline, 6-month and 12-month.

Discussion: We are aiming for a net improvement in the KAB score in participants of the e-intervention group, besides investigating the impact of the e-intervention on the dietary practices, physical measurements and blood biomarkers of those patients. The successful outcome of this study can be a precursor for policy makers to initiate more rigorous promotion of such web-based programmes in the country.

Trial registration: Clinicaltrials.gov NCT01246687.

Figures

Figure 1
Figure 1
Flow chart of the proposed study.
Figure 2
Figure 2
Conceptual framework.
Figure 3
Figure 3
The website structure.

References

    1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27(5):1047–53. doi: 10.2337/diacare.27.5.1047.
    1. National Health Morbidity Survery III. The Third National Health and Morbidity Survey (NHMS III) 2006. Institute for Public Health, Kuala Lumpur; 2008.
    1. Stratton IM, Adler AI, Neil HAW, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321(7258):405–12. doi: 10.1136/bmj.321.7258.405.
    1. Deshpande AD, Harris-Hayes M, Schootman M. Epidemiology of Diabetes and Diabetes-Related Complications. Phys Ther. 2008;88(11):1254–64. doi: 10.2522/ptj.20080020.
    1. Glasgow RE, Boles SM, McKay HG, Feil EG, Barrera M Jr. The D-Net diabetes self-management program: Long-term implementation, outcomes, and generalization results. Prev Med. 2003;36(4):410–9. doi: 10.1016/S0091-7435(02)00056-7.
    1. Meigs JB, Cagliero E, Dubey A, Murphy-Sheehy P, Gildesgame C, Chueh H, Barry MJ, Singer DE, Nathan DM. A Controlled Trial of Web-Based Diabetes Disease Management: The MGH Diabetes Primary Care Improvement Project. Diabetes Care. 2003;26(3):750–7. doi: 10.2337/diacare.26.3.750.
    1. Kim HS, Yoo YS, Shim H-S. Effects of an Internet-based Intervention on Plasma Glucose Levels in Patients With Type 2 Diabetes. J Nurs Care Qual. 2005;20(4):335–40. doi: 10.1097/00001786-200510000-00009.
    1. Lee TI, Yeh YT, Liu CT, Chen P-L. Development and evaluation of a patient-oriented education system for diabetes management. Int J Med Inform. 2007;76(9):655–63. doi: 10.1016/j.ijmedinf.2006.05.030.
    1. McKay HG, King D, Eakin EG, Seeley JR, Glasgow RE. The diabetes network internet-based physical activity intervention: a randomized pilot study. Diabetes Care. 2001;24(8):1328–34. doi: 10.2337/diacare.24.8.1328.
    1. Kim CJ, Kang DH. Utility of a Web-based Intervention for Individuals With Type 2 Diabetes: The Impact on Physical Activity Levels and Glycemic Control. CIN. 2006;24(6):337–45.
    1. Tate DF, Jackvony EH, Wing RR. Effects of Internet Behavioral Counseling on Weight Loss in Adults at Risk for Type 2 Diabetes: A Randomized Trial. JAMA. 2003;289(14):1833–6. doi: 10.1001/jama.289.14.1833.
    1. McCoy MR, Couch D, Duncan ND, Lynch GS. Evaluating an Internet weight loss program for diabetes prevention. Health Promot Int. 2005;20(3):221–8. doi: 10.1093/heapro/dai006.
    1. Long JD, Armstrong ML, Amos E, Shriver B, Roman-Shriver C, Feng D, Harrison L, Luker S, Nash A, Blevins MW. Pilot Using World Wide Web to Prevent Diabetes in Adolescents. Clin Nurs Res. 2006;15(1):67–79. doi: 10.1177/1054773805282446.
    1. Wolf AM, Conaway MR, Crowther JQ, Hazen KY, L.Nadler J, Oneida B, Bovbjerg VE. Translating Lifestyle Intervention to Practice in Obese Patients With Type 2 Diabetes. Diabetes Care. 2004;27(7):1570–6. doi: 10.2337/diacare.27.7.1570.
    1. Singh PM, Wight CA, Sercinoglu O, Wilson DC, Boytsov A, Raizada MN. Language Preferences on Websites and in Google Searches for Human Health and Food Information. J Med Internet Res. 2007;9(2):e18. doi: 10.2196/jmir.9.2.e18.
    1. Woodall WG, Buller DB, Saba L, Zimmerman D, Waters E, Hines JM, Cutter GR, Starling R. Effect of emailed messages on return use of a nutrition education website and subsequent changes in dietary behavior. J Med Internet Res. 2007;9(3):e27. doi: 10.2196/jmir.9.3.e27.
    1. Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983;51(3):390–5.
    1. de Vet E, dN J, de Vries NK, Brug J. The Transtheoretical model for fruit, vegetable and fish consumption: associations between intakes, stages of change and stage transition determinants. Int J Behav Nutr Phys Act. 2006;3:13. doi: 10.1186/1479-5868-3-13.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, Group ftC. Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration. Ann Intern Med. 2008;148(4):295–309.
    1. Glasgow RE, Toobert DJ, Hampson SE, Strycker LA. Implementation, generalization and long-term results of the "choosing well" diabetes self-management intervention. Patient Educ Counsel. 2003;48(2):115–22.
    1. Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: A flexible statistical power analysis for the social, behavioral, and biomedical sciences. Behav Res Method. 2007;39:175–91. doi: 10.3758/BF03193146.
    1. American Diabetes Association. Nutrition Recommendations and Interventions for Diabetes: A position statement of the American Diabetes Association. Diabetes Care. 2008;31(Supp 1):S61–78.
    1. Ministry of Health and Academy of Medicine of Malaysia. Malaysian Clinical Practice Guidelines: Management of Type 2 Diabetes Mellitus. 4. 2009.
    1. Malaysian Dietitians' Association, Ministry of Health. Malaysian Medical Nutrition Therapy for Type 2 Diabetes. Malaysian Dietitians' Association; 2005.
    1. Gibson R. In: Measuring food consumption of individuals. Gibson R, editor. Oxford University Press, New York; 2005.
    1. Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallies JF, Oja P. International Physical Activity Questionnaire: 12-Country Reliability and Validity. Med Sci Sports Exerc. 2003;35(8):1381–95. doi: 10.1249/01.MSS.0000078924.61453.FB.
    1. Williams JH, Auslander WF, de Groot M, Robinson AD, Houston C, Haire-Joshu D. Cultural Relevancy of a Diabetes Prevention Nutrition Program for African American Women. Health Promot Pract. 2006;7(1):56–67. doi: 10.1177/1524839905275393.

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren