Examining the impact of genetic testing for type 2 diabetes on health behaviors: Study protocol for a randomized controlled trial

Trials

Volumn 13, Issue , 2012, Pages

  Voils, Corrine I ^a,b   Coffman, Cynthia J ^a,b   Edelman, David ^a,b   Maciejewski, Matthew L ^a,b   Grubber, Janet M ^a   Sadeghpour, Azita ^a   Cho, Alex ^b   McKenzie, Jamiyla ^a   Blanpain, Francoise ^b   Scheuner, Maren ^c,d   Sandelowski, Margarete ^e   Gallagher, M P ^a   Ginsburg, Geoffrey S ^b   Yancy Jr, William S ^a,b  

^a DURHAM VA MEDICAL CENTER   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c VA GREATER LOS ANGELES HEALTHCARE SYSTEM   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e UNIVERSITY OF NORTH CAROLINA   (United States)

Author keywords

Genetic testing; Type II diabetes; Weight loss

Indexed keywords

ADULT; AGED; ARTICLE; BODY MASS; CONTROLLED STUDY; DISEASE ASSOCIATION; EYE DISEASE; GENETIC COUNSELING; GENETIC SCREENING; HEALTH BEHAVIOR; HUMAN; LIFESTYLE MODIFICATION; MAJOR CLINICAL STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT COUNSELING; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; STUDY DESIGN; ATTITUDE TO HEALTH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; FEMALE; GENETIC PREDISPOSITION; GENETICS; MALE; METHODOLOGY; MIDDLE AGED; PATIENT SELECTION; PREDICTIVE VALUE; RISK FACTOR; RISK REDUCTION; TIME; UNITED STATES;

ADULT; AGED; DIABETES MELLITUS, TYPE 2; FEMALE; GENETIC COUNSELING; GENETIC PREDISPOSITION TO DISEASE; GENETIC TESTING; HEALTH BEHAVIOR; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; MALE; MIDDLE AGED; NORTH CAROLINA; PATIENT SELECTION; PREDICTIVE VALUE OF TESTS; RESEARCH DESIGN; RISK ASSESSMENT; RISK FACTORS; RISK REDUCTION BEHAVIOR; TIME FACTORS; YOUNG ADULT;

EID: 84864398715     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-121     Document Type: Article

References (36)

1. Bloss CS, Schork NJ, Topol EJ. Effect of direct-to-consumer genomewide profiling to assess disease risk. N Engl J Med 2011, 364:524-534. 10.1056/NEJMoa1011893, 21226570.
2. Mountcastle-Shah E, Holtzman NA. Primary care physicians' perceptions of barriers to genetic testing and their willingness to participate in research. Am J Med Gen 2000, 94:409-416.
3. Adriaanse MC, Snoek FJ, Dekker JM, Spijkerman AM, Nijpels G, van der Ploeg HM, Heine RJ. Perceived risk for Type 2 diabetes in participants in a stepwise population-screening programme. Diabet Med 2003, 20:210-215. 10.1046/j.1464-5491.2003.00901.x, 12675665.
4. Wee H-L, Cheung Y-B, Li S-C, Fong K-Y, Thumboo J. The impact of diabetes mellitus and other chronic medical conditions on health-related Quality of Life: Is the whole greater than the sum of its parts?. Health Qual Life Outcomes 2005, 3:2. 10.1186/1477-7525-3-2, 548134, 15644146.
5. Lyssenko V, Jonsson A, Almgren P, Pulizzi N, Isomaa B, Tuomi T, Berglund G, Altshuler D, Nilsson P, Groop L. Clinical risk factors, DNA variants, and the development of type 2 diabetes. N Engl J Med 2008, 359:2220-2232. 10.1056/NEJMoa0801869, 19020324.
6. Florez JC, Jablonski KA, Bayley N, Pollin TI, de Bakker PI, Shuldiner AR, Knowler WC, Nathan DM, Altshuler D. TCF7L2 polymorphisms and progression to diabetes in the Diabetes Prevention Program. N Engl J Med 2006, 355:241-250. 10.1056/NEJMoa062418, 1762036, 16855264.
7. Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care 2002, 40:771-781. 10.1097/00005650-200209000-00007, 12218768.
8. Fagerlin A, Zikmund-Fisher BJ, Ubel PA, Jankovic A, Derry HA, Smith DM. Measuring numeracy without a math test: Development of the Subjective Numeracy Scale. Med Decis Making 2007, 27:672-680. 10.1177/0272989X07304449, 17641137.
9. Chang M-, Valdez R, Ned RM, Liu T, Yang Q, Yesupriya A, Dowling NF, Meigs JB, Bowen MS, Khoury MJ. Influence of familial risk on diabetes risk-reducing behaviors among U.S. adults without diabetes. Diabetes Care 2011,
10. Weedon MN, McCarthy MI, Hitman G, Walker M, Groves CJ, Zeggini E, Rayner NW, Shields B, Owen KR, Hattersley AT, Frayling TM. Combining information from common type 2 diabetes risk polymorphisms improves disease prediction. PLoS Med 2006, 3:e374. 10.1371/journal.pmed.0030374, 1584415, 17020404.
11. Weinstein N. What does it mean to understand a risk? Evaluation risk comprehension. J Natl Cancer Inst Monogr 1999, 25:15-20.
12. Hsee CK. The evaluability hypothesis: An explanation for preference reversals between joint and separate evaluations of alternatives. Organ Behav Hum 1996, 67:247-257.
13. Hsee CK. Less is better: When low-value options are valued more highly than high-value options. J Behav Decis Making 1998, 11:107-121.
14. Nelson W, Reyna VF, Fagerlin A, Lipkus I, Peters E. Clinical implications of numeracy: Theory and practice. Ann Behav Med 2008, 35:261-274. 10.1007/s12160-008-9037-8, 18677452.
15. Narayan KM, Boyle JP, Thompson TJ, Gregg EW, Williamson DF. Effect of BMI on lifetime risk for diabetes in the U.S. Diabetes Care 2007, 30:1562-1566. 10.2337/dc06-2544, 17372155.
16. Hariri S, Yoon P, Qureshi N, Valdez R, Scheuner M, Khoury M. Family history of type 2 diabetes: A population-based screening tool for prevention?. Genet Med 2006, 8:102-108. 10.1097/01.gim.0000200949.52795.df, 16481893.
17. Nichols GA, Hillier TA, Brown JB. Progression from newly acquired impaired fasting glusose to type 2 diabetes. Diabetes Care 2007, 30:228-233. 10.2337/dc06-1392, 1851903, 17259486.
18. Hill S, Spink J, Cadilhac D, Edwards A, Kaufman C, Rogers S, Ryan R, Tonkin A. Absolute risk representation in cardiovascular disease prevention: comprehension and preferences of health care consumers and general practitioners involved in a focus group study. BMC Public Health 2010, 10:108. 10.1186/1471-2458-10-108, 2845101, 20199692.
19. Tay J, Brinkworth GD, Noakes M, Keogh J, Clifton PM. Metabolic effects of weight loss on a very-low-carbohydrate diet compared with an isocaloric high-carbohydrate diet in abdominally obese subjects. J Am Coll Cardiol 2008, 51:59-67. 10.1016/j.jacc.2007.08.050, 18174038.
20. Gregg EW, Cheng YJ, Narayan KM, Thompson TJ, Williamson DF. The relative contributions of different levels of overweight and obesity to the increased prevalence of diabetes in the United States: 1976-2004. Prev Med 2007, 45:348-352. 10.1016/j.ypmed.2007.07.020, 17889292.
21. Hamman RF, Wing RR, Edelstein SL, Lachin JM, Bray GA, Delahanty L, Hoskin M, Kriska AM, Mayer-Davis EJ, Pi-Sunyer X, et al. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care 2006, 29:2102-2107. 10.2337/dc06-0560, 1762038, 16936160.
22. Broadbent E, Petrie KJ, Main J, Weinman J. The Brief Illness Perception questionnaire. J Psychosom Res 2006, 60:631-637. 10.1016/j.jpsychores.2005.10.020, 16731240.
23. Cancer Prevention Research Center Measures http://www.uri.edu/research/cprc/measures.htm.
24. McCann BS, Bovbjerg VE, Brief DJ, Turner C, Follette WC, Fitzpatrick V, Dowdy A, Retzlaff B, Walden CE, Knopp RH. Relationship of self-efficacy to cholesterol lowering and dietary change in hyperlipidemia. Ann Beh Med 1995, 17:221-226.
25. Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res 2000, 49:154-159. 10.1097/00006199-200005000-00007, 10882320.
26. Cella D, Hughes C, Peterman A, Chang CH, Peshkin BN, Schwartz MD, Wenzel L, Lemke A, Marcus AC, Lerman C. A brief assessment of concerns associated with genetic testing for cancer: The Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire. Health Psychol 2002, 21:564-572.
27. Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc 2003, 35:1381-1395. 10.1249/01.MSS.0000078924.61453.FB, 12900694.
28. Group IEEW. ICH harmonised tripartite guideline - statistical principles for clinical trials. Stat Med 1999, 18:1905-1942.
29. Verbeke G, Molenbergh G. Linear mixed models for longitudinal data 2000, Springer, New York.
30. Schafer J. Analysis of incomplete multivariate data 1997, Chapman & Hall, London.
31. Borm G, Fransen J, Lemmens W. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol 2007, 60:1234-1238. 10.1016/j.jclinepi.2007.02.006, 17998077.
32. Yancy W, Westman E, McDuffie J, Grambow S, Jeffreys A, Bolton J, Chalecki A, Oddone EZ. A randomized trial of a low-carbohydrate, ketogenic diet versus orlistat plus a low-fat diet for weight loss. Arch Int Med 2010, 170:136-145.
33. Lindstrom 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, 14633807.
34. Garrison L, Mansley E, Abbott T, Bresnahan B, Hay J, Smeeding J. Good research practices for measuring drug costs in cost-effectiveness analyses: A societal perspective: The ISPOR Drug Cost Task Force Report-Part II. Value Health 2010, 13:8-13. 10.1111/j.1524-4733.2009.00660.x, 19883405.
35. Bloss CS, Madlensky L, Schork NJ, Topol EJ. Genomic information as a behavioral health intervention: Can it work?. Per Med 2011, 8:659-667. 10.2217/pme.11.73, 22199991.
36. Bloss CS, Darst BF, Topol EJ, Schork NJ. Direct-to-consumer personalized genomic testing. Hum Mol Genet 2011, 20:R132-R141. 10.1093/hmg/ddr349, 21828075.