Randomized controlled trial of the effectiveness of genetic counseling and a distance, computer-based, lifestyle intervention program for adult offspring of patients with type 2 diabetes: Background, study protocol, and baseline patient characteristics

Journal of Nutrition and Metabolism

Volumn 2012, Issue , 2012, Pages

  Nishigaki, M ^a   Tokunaga Nakawatase, Y ^a   Nishida, J ^b   Taru, C ^c   Miyawaki, I ^c   Sanada, H ^a   Kazuma, K ^a  

^a UNIVERSITY OF TOKYO   (Japan)

^b Social Insurance Central General Hospital   (Japan)

^c KOBE UNIVERSITY   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84873868654     PISSN: 20900724     EISSN: 20900732     Source Type: Journal    
DOI: 10.1155/2012/831735     Document Type: Article

References (67)

1. Diabetes Prevention Program Research Group, Knowler W. C., Fowler S. E., 10-year follow-up of Diabetes incidence and weight loss in the Diabetes prevention program outcomes study. The Lancet 2009 374 9702 1677 1686 2-s2.0-70449517253 10.1016/S0140-6736(09)61457-4
2. Knowler W. C., Barrett-Connor E., Fowler S. E., Hamman R. F., Lachin J. M., Walker E. A., Nathan D. M., Reduction in the incidence of type 2 Diabetes with lifestyle intervention or metformin. The New England Journal of Medicine 2002 346 6 393 403 2-s2.0-0037034257 10.1056/NEJMoa012512 (Pubitemid 34437694)
3. Tuomilehto J., Lindström J., Eriksson J. G., Valle T. T., Hamäläinen H., Ianne-Parikka P., Keinänen-Kiukaanniemi S., Laakso M., Louheranta A., Rastas M., Salminen V., Uusitupa M., Prevention of type 2 Diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. The New England Journal of Medicine 2001 344 18 1343 1350 2-s2.0-0035799806 10.1056/NEJM200105033441801 (Pubitemid 32378388)
4. Li G., guangwei-li@medmail.com.cn Zhang P., pzhang@cdc.gov Wang J., Gregg E. W., Yang W., Gong Q., Li H., Li H., Jiang Y., An Y., Shuai Y., Zhang B., Zhang J., Thompson T. J., Gerzoff R. B., Roglic G., Hu Y., Bennett P. H., The long-term effect of lifestyle interventions to prevent diabetes in the China Da Qing Diabetes Prevention Study: a 20-year follow-up study. The Lancet 2008 371 9626 1783 1789 10.1016/S0140-6736(08)60766-7 (Pubitemid 351697954)
5. Pan X. R., Li G. W., Hu Y. H., Wang J. X., Yang W. Y., An Z. X., Hu Z. X., Lin J., Xiao J. Z., Cao H. B., Liu P. A., Jiang X. G., Jiang Y. Y., Wang J. P., Zheng H., Zhang H., Bennett P. H., Howard B. V., Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance: the Da Qing IGT and Diabetes study. Diabetes Care 1997 20 4 537 544 2-s2.0-0030935652 (Pubitemid 27143412)
6. Kosaka K., Noda M., Kuzuya T., Prevention of type 2 Diabetes by lifestyle intervention: a Japanese trial in IGT males. Diabetes Research and Clinical Practice 2005 67 2 152 162 2-s2.0-11844305996 10.1016/j.diabres.2004.06.010 (Pubitemid 40093025)
7. Ramachandran A., Snehalatha C., Mary S., Mukesh B., Bhaskar A. D., Vijay V., The Indian Diabetes prevention programme shows that lifestyle modification and metformin prevent type 2 Diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia 2006 49 2 289 297 2-s2.0-31844452061 10.1007/s00125-005-0097-z (Pubitemid 43185397)
8. Crandall J. P., Knowler W. C., Kahn S. E., Marrero D., Florez J. C., Bray G. A., Haffner S. M., Hoskin M., Nathan D. M., The prevention of type 2 Diabetes. Nature Clinical Practice Endocrinology and Metabolism 2008 4 7 382 393 2-s2.0-45849132668 10.1038/ncpendmet0843 (Pubitemid 351881862)
9. Finucane M. M., Stevens G. A., Cowan M. J., National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9.1 million participants. The Lancet 2011 377 9765 557 567 10.1016/S0140-6736(10) 62037-5
10. Sone H., Ito H., Ohashi Y., Akanuma Y., Yamada N., jdcstudy@md.tsukuba. ac.jp Obesity and type 2 Diabetes in Japanese patients. The Lancet 2003 361 9351 85 (Pubitemid 36050984)
11. Kadowaki T., Hara K., Yamauchi T., Terauchi Y., Tobe K., Nagai R., Molecular mechanism of insulin resistance and obesity. Experimental Biology and Medicine 2003 228 10 1111 1117 2-s2.0-0242694056 (Pubitemid 37413667)
12. Matsuoka K., Genetic and environmental interaction in Japanese type 2 diabetics. Diabetes Research and Clinical Practice 2000 50 supplement 2 S17 S22 2-s2.0-0033802487 10.1016/S0168-8227(00)00174-1
13. Osawa H., Tabara Y., Kawamoto R., Ohashi J., Ochi M., Onuma H., Nishida W., Yamada K., Nakura J., Kohara K., Miki T., Makino H., Plasma resistin, associated with single nucleotide polymorphism -420, is correlated with insulin resistance, lower HDL cholesterol, and high-sensitivity C-reactive protein in the Japanese general population. Diabetes Care 2007 30 6 1501 1506 2-s2.0-34249873504 10.2337/dc06-1936 (Pubitemid 46871161)
14. Okamoto K., Iwasaki N., Nishimura C., Doi K., Noiri E., Nakamura S., Takizawa M., Ogata M., Fujimaki R., Grarup N., Pisinger C., Borch-Johnsen K., Lauritzen T., Sandbaek A., Hansen T., Yasuda K., Osawa H., Nanjo K., Kadowaki T., Kasuga M., Pedersen O., Fujita T., Kamatani N., Iwamoto Y., Tokunaga K., Identification of KCNJ15 as a susceptibility gene in Asian patients with type 2 Diabetes mellitus. American Journal of Human Genetics 2010 86 1 54 64 2-s2.0-73149110158 10.1016/j.ajhg.2009.12.009
15. Harrison T. A., Hindorff L. A., Kim H., Wines R. C. M., Bowen D. J., McGrath B. B., Edwards K. L., Family history of Diabetes as a potential public health tool. American Journal of Preventive Medicine 2003 24 2 152 159 2-s2.0-0037304743 10.1016/S0749-3797(02)00588-3 (Pubitemid 36144093)
16. Hariri S., Yoon P. W., Qureshi N., Valdez R., Scheuner M. T., Khoury M. J., Family history of type 2 Diabetes: a population-based screening tool for prevention? Genetics in Medicine 2006 8 2 102 108 2-s2.0-33645422488 10.1097/01.gim.0000200949.52795.df
17. Hariri S., Yoon P. W., Moonesinghe R., Valdez R., Khoury M. J., Evaluation of family history as a risk factor and screening tool for detecting undiagnosed Diabetes in a nationally representative survey population. Genetics in Medicine 2006 8 12 752 759 2-s2.0-33845776577 10.1097/01.gim.0000250205. 73963.f3 (Pubitemid 44973763)
18. Kuzuya T., Matsuda A., Family histories of Diabetes among Japanese patients with type 1 (insulin-dependent) and type 2 (non-insulin-dependent) Diabetes. Diabetologia 1982 22 5 372 374 2-s2.0-0020047654 (Pubitemid 12154525)
19. Valdez R., Yoon P. W., Liu T., Khoury M. J., Family history and prevalence of Diabetes in the U.S. population: the 6-year results from the national health and nutrition examination survey (1999-2004). Diabetes Care 2007 30 10 2517 2522 2-s2.0-35148865667 10.2337/dc07-0720 (Pubitemid 47547786)
20. Khoury M. J., Valdez R., Albright A., Public health genomics approach to type 2 Diabetes. Diabetes 2008 57 11 2911 2914 2-s2.0-58149347534 10.2337/db08-1045
21. Stolerman E. S., Florez J. C., Genomics of type 2 Diabetes mellitus: implications for the clinician. Nature Reviews Endocrinology 2009 5 8 429 436 2-s2.0-70349196136 10.1038/nrendo.2009.129
22. Brekke H. K., Jansson P. A., Månsson J. E., Lenner R. A., Lifestyle changes can be achieved through counseling and follow-up in first-degree relatives of patients with type 2 Diabetes. Journal of the American Dietetic Association 2003 103 7 835 843 2-s2.0-0041706986 10.1016/S0002-8223(03)00378-X (Pubitemid 44354872)
23. Brekke H. K., Jansson P. A., Lenner R. A., Long-term (1- and 2-year) effects of lifestyle intervention in type 2 Diabetes relatives. Diabetes Research and Clinical Practice 2005 70 3 225 234 2-s2.0-27544450724 10.1016/j.diabres.2005.03.027 (Pubitemid 41539783)
24. Nishigaki M., nishigaki-tky@umin.ac.jp Ota A., Kusakabe T., Matsuzaki C., Taguchi S., Kazuma K., Feasibility and efficiency of indirect lifestyle interventions in offspring of type 2 diabetic patients. Public Health Genomics 2011 14 2 77 84 10.1159/000294217
25. Pierce M., Ridout D., Harding D., Keen H., Bradley C., More good than harm: a randomised controlled trial of the effect of education about familial risk of Diabetes on psychological outcomes. British Journal of General Practice 2000 50 460 867 871 2-s2.0-0033768019
26. Weil J., Psychosocial Genetic Counseling 2000 New York, NY, USA Oxford University Press
27. Wilson B. J., Forrest K., Van Teijlingen E. R., McKee L., Haites N., Matthews E., Simpson S. A., Family communication about genetic risk: the little that is known. Community Genetics 2004 7 1 15 24 2-s2.0-5644244157 10.1159/000080300
28. Bonomo K., Fiora E., Caccavale A., Traversa M., Chirio M., Marchesini G., Trovati M., Diabetes prevention strategy in offspring of type 2 diabetic patients with a direct involvement of the diseased parents. Nutrition, Metabolism and Cardiovascular Diseases 2005 15 3 237 238 2-s2.0-21644444234 10.1016/j.numecd.2004.08.004 (Pubitemid 40934170)
29. Nishigaki M., Kobayashi K., Abe Y., Seki N., Yokomura T., Yokoyama M., Kazuma K., Preventive behaviour in adult offspring of type 2 diabetic patients and its relationship to parental advice. Diabetic Medicine 2008 25 11 1343 1348 2-s2.0-55149124940 10.1111/j.1464-5491.2008.02582.x
30. Yoon P. W., Scheuner M. T., Peterson-Oehlke K. L., Gwinn M., Faucett A., Khoury M. J., Can family history be used as a tool for public health and preventive medicine? Genetics in Medicine 2002 4 4 304 310 2-s2.0-0036653105 10.1097/00125817-200207000-00009 (Pubitemid 44698565)
31. Yoon P. W., Scheuner M. T., Khoury M. J., Research priorities for evaluating family history in the prevention of common chronic diseases. American Journal of Preventive Medicine 2003 24 2 128 135 2-s2.0-12244303612 10.1016/S0749-3797(02)00585-8 (Pubitemid 36144090)
32. Leventhal H., Weinman J., Leventhal E. A., Alison Phillips L., Health psychology: the search for pathways between behavior and health. Annual Review of Psychology 2008 59 477 505 2-s2.0-41549128517 10.1146/annurev.psych.59. 103006.093643
33. Rosenstock I. M., Why people use health services. The Milbank Memorial Fund quarterly 1966 44 3 94 127 2-s2.0-0013924605
34. Baum A., Friedman A. L., Zakowski S. G., Stress and genetic testing for disease risk. Health Psychology 1997 16 1 8 19 2-s2.0-0030638686 (Pubitemid 127465950)
35. Scheuner M. T., Sieverding P., Shekelle P. G., Delivery of genomic medicine for common chronic adult diseases: a systematic review. Journal of the American Medical Association 2008 299 11 1320 1334 2-s2.0-40949112321 10.1001/jama.299.11.1320 (Pubitemid 351439078)
36. Sherwood N. E., Morton N., Jeffery R. W., French S. A., Neumark-Sztainer D., Falkner N. H., Consumer preferences in format and type of community-based weight control programs. American Journal of Health Promotion 1998 13 1 12 18 2-s2.0-0031754092 (Pubitemid 28428000)
37. Kroeze W., Oenema A., Campbell M., Brug J., Comparison of use and appreciation of a print-delivered versus CD-ROM-delivered, computer-tailored intervention targeting saturated fat intake: randomized controlled trial. Journal of Medical Internet Research 2008 10 2, article e12 2-s2.0-45849099151 10.2196/jmir.940 (Pubitemid 351880962)
38. Brug J., Oenema A., Campbell M., Past, present, and future of computer-tailored nutrition education. The American Journal of Clinical Nutrition 2003 77 supplement 4 1028S 1034S 2-s2.0-0037395687
39. Castro C. M., King A. C., Telephone-assisted counseling for physical activity. Exercise and Sport Sciences Reviews 2002 30 2 64 68 2-s2.0-0036216499 (Pubitemid 34298806)
40. Terry P. E., Seaverson E. L. D., Staufacker M. J., Gingerich S. B., A comparison of the effectiveness of a telephone coaching program and a mail-based program. Health Education & Behavior 2010 37 6 895 912 2-s2.0-78650157640 10.1177/1090198110367876
41. Kreuter M. W., Strecher V. J., Glassman B., One size does not fit all: the case for tailoring print materials. Annals of Behavioral Medicine 1999 21 4 276 283 2-s2.0-0033508422 (Pubitemid 30149369)
42. De Vries H., Brug J., Computer-tailored interventions motivating people to adopt health promoting behaviours: introduction to a new approach. Patient Education and Counseling 1999 36 2 99 105 2-s2.0-0033084052 10.1016/S0738- 3991(98)00127-X (Pubitemid 29078650)
43. Kroeze W., Werkman A., Brug J., A systematic review of randomized trials on the effectiveness of computer-tailored education on physical activity and dietary behaviors. Annals of Behavioral Medicine 2006 31 3 205 223 2-s2.0-33744738275 10.1207/s15324796abm3103-2 (Pubitemid 43825346)
44. Adachi Y., Sato C., Yamatsu K., Ito S., Adachi K., Yamagami T., A randomized controlled trial on the long-term effects of a 1-month behavioral weight control program assisted by computer tailored advice. Behaviour Research and Therapy 2007 45 3 459 470 2-s2.0-33846401211 10.1016/j.brat.2006.03.017 (Pubitemid 46135516)
45. Fujii H., Nakade M., Haruyama Y., Fukuda H., Hashimoto M., Ikuyama T., Kaburagi H., Murai E., Okumura M., Sairenchi T., Muto T., Evaluation of a computer-tailored lifestyle modification support tool for employees in Japan. Industrial Health 2009 47 3 333 341 2-s2.0-68549109425 10.2486/indhealth.47.333
46. Tanaka M., Adachi Y., Adachi K., Sato C., Effects of a non-face-to-face behavioral weight-control program among Japanese overweight males: a randomized controlled trial. International Journal of Behavioral Medicine 2010 17 1 17 24 2-s2.0-77649187449 10.1007/s12529-009-9057-1
47. Schulz K. F., Altman D. G., Moher D., Consort 2010 statement: updated guidelines for reporting parallel group randomised trials. British Medical Journal 2010 340 c332 2-s2.0-77950362357 10.1136/bmj.c332
48. Nishigaki M., Sato E., Ochiai R., Shibayama T., Kazuma K., Impact of a boklet about Diabetes genetic susceptibility and it's prevention on attitudes towards prevention and perceived behavioral change in patients with type 2 Diabetes and their offspring. Advances in Preventive Medicine 2011 2011 1 7 10.4061/2011/365132
49. Schulze M. B., Hu F. B., Primary prevention of Diabetes: what can be done and how much can be prevented? Annual Review of Public Health 2005 26 445 467 2-s2.0-17444423605 10.1146/annurev.publhealth.26.021304.144532 (Pubitemid 40547392)
50. Qi L., Hu F. B., Hu G., Genes, environment, and interactions in prevention of type 2 Diabetes: a focus on physical activity and lifestyle changes. Current Molecular Medicine 2008 8 6 519 532 2-s2.0-53149093601 10.2174/156652408785747915
51. Uusitupa M., Gene-diet interaction in relation to the prevention of obesity and type 2 Diabetes: evidence from the Finnish Diabetes Prevention Study. Nutrition, Metabolism & Cardiovascular Diseases 2005 15 3 225 233 2-s2.0-21644460163 10.1016/j.numecd.2005.03.004 (Pubitemid 40934168)
52. Taru C., Tsutou A., Nakawatase Y., Usami M., Miyawaki I., Gender differences of dietary self-management behavior affecting control indices in type II Diabetes. Kobe Journal of Medical Sciences 2008 54 2 E82 E96 2-s2.0-47849123030 (Pubitemid 352039820)
53. Taru C., Nakawatase Y., Tsutou A., Tamori Y., Noguchi T., Kido Y., Ohara T., Ogawa W., Miyawaki I., Dietary self-management behavior and actual energy intake analyzed from individual type 2 diabetic patient clinical indices. Journal of the Japan Diabetes Society 2008 51 2 125 138 2-s2.0-44349141243
54. Nakawatase Y., Taru C., Tsutou A., Shiotani H., Kido Y., Ohara T., Ogawa W., Miyawaki I., Development of an evaluation scale for self-management behavior related to physical activity of type 2 diabetic patients. Diabetes Care 2007 30 11 2843 2848 2-s2.0-36049010337 10.2337/dc07-0685 (Pubitemid 350083130)
55. Taru C., Miyawaki I., Yada M., Development of a dietary self-management behavior questionnaire of patients with type 2 Diabetes. Journal of Japan Academy of Diabetes Education and Nursing 2007 11 1 4 18
56. Taru C., Tsutou A., Miyawaki I., A modified simple questionnaire to estimate dietary energy intake for the Japanese. Kobe Jornal of Medical Sciences 2011 57 3 106 115
57. Murase N., Katsumura T., Ueda C., Inoue S., Shimomitsu T., International standardization of the amount of physical activity-assessment of reliability and validity of IPAQ Japanese version. Journal of Health and Welfare Statistics 2002 49 11 1 9
58. Hagströmer M., Oja P., Sjöström M., The international physical activity questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutrition 2006 9 6 755 762 2-s2.0-33846850165 10.1079/PHN2005898 (Pubitemid 46211749)
59. Bassett D. R. Jr., International physical activity questionnaire: 12-country reliability and validity. Medicine & Science in Sports & Exercise 2003 35 8 1396 2-s2.0-0642333776 10.1249/01.MSS.0000078923.96621.1D (Pubitemid 36936160)
60. Sladek R., Rocheleau G., Rung J., Dina C., Shen L., Serre D., Boutin P., Vincent D., Belisle A., Hadjadj S., Balkau B., Heude B., Charpentier G., Hudson T. J., Montpetit A., Pshezhetsky A. V., Prentki M., Posner B. I., Balding D. J., Meyre D., Polychronakos C., Froguel P., A genome-wide association study identifies novel risk loci for type 2 Diabetes. Nature 2007 445 7130 881 885 2-s2.0-33847176604 10.1038/nature05616
61. Grant R. W., Moore A. F., Florez J. C., Genetic architecture of type 2 Diabetes: recent progress and clinical implications. Diabetes Care 2009 32 6 1107 1114 2-s2.0-66549087600 10.2337/dc08-2171
62. Meigs J. B., Shrader P., Sullivan L. M., McAteer J. B., Fox C. S., Dupuis J., Manning A. K., Florez J. C., Wilson P. W. F., D'Agostino R. B., Cupples L. A., Genotype score in addition to common risk factors for prediction of type 2 Diabetes. The New England Journal of Medicine 2008 359 21 2208 2219 2-s2.0-56749101779 10.1056/NEJMoa0804742
63. 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. The New England Journal of Medicine 2008 359 21 2220 2232 2-s2.0-55649105963 10.1056/NEJMoa0801869
64. Langothe H., Palmer C. N. A., Morris A. D., Assessing the combined impact of 18 common genetic variants of modest effect sizes on type 2 Diabetes risk. Diabetes 2008 57 11 3129 3135 10.2337/db08-0504
65. Van Hoek M., Dehghan A., Witteman J. C. M., Van Duijn C. M., Uitterlinden A. G., Oostra B. A., Hofman A., Sijbrands E. J. G., Janssens A. C. J. W., Predicting type 2 Diabetes based on polymorphisms from genome-wide association studies a population-based study. Diabetes 2008 57 11 3122 3128 2-s2.0-58149333712 10.2337/db08-0425
66. Bloss C. S., Schork N. J., Topol E. J., etopol@scripps.edu Effect of direct-to-consumer genomewide profiling to assess disease risk. The New England Journal of Medicine 2011 364 6 524 534 10.1056/NEJMoa1011893
67. Arkadianos I., Valdes A. M., Marinos E., Florou A., Gill R. D., Grimaldi K. A., Improved weight management using genetic information to personalize a calorie controlled diet. Nutrition Journal 2007 6, article 29 2-s2.0-37349130284 10.1186/1475-2891-6-29 (Pubitemid 350308688)