A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes

Journal of Translational Medicine

Juliana CN Chan⁴  Gang Hu³  Zhijie Yu²  Ling Dong¹  Gongsu Liu¹  Leishen Wang¹  Junhong Leng¹  Yi Li¹  Cuiping Zhang¹  Fuxia Zhang¹  Huiguang Tian¹  Xilin Yang⁴ 

[1] Tianjin Women and Children¿s Health Centre, Tianjin, China;Population Cancer Research Program and Department of Pediatrics, Dalhousie University, Halifax, Canada;Chronic Disease Epidemiology Laboratory, Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA;Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity, The Chinese University of Hong Kongand The Chinese University of Hong Kong-Prince of Wales Hospital-International Diabetes Federation Centre of Education, Hong Kong, China

关键词: Large for gestational age;    Macrosomia;    Lifestyle intervention;    Self-monitoring of blood glucose;    Shared care;    Gestational diabetes mellitus;    Randomised controlled trial;   

Others  :  1147368
DOI  :  10.1186/s12967-014-0290-2

 received in 2014-08-20, accepted in 2014-10-07,  发布年份 2014

【 摘 要 】

Background

There are no randomised controlled trials to demonstrate whether lifestyle modifications can improve pregnancy outcomes of gestational diabetes mellitus (GDM) diagnosed by the International Association of Diabetes and Pregnancy Study Group¿s (IADPSG) criteria. We tested the effectiveness of lifestyle modifications implemented in a 3-tier¿s shared care (SC) on pregnancy outcomes of GDM.

Methods

Between December 2010 and October 2012, we randomly assigned 700 women with IADPSG-defined GDM but without diabetes at 26.3 (interquartile range: 25.4-27.3) gestational weeks in Tianjin, China, to receive SC or usual care (UC). The SC group received individual consultations and group sessions and performed regular self-monitoring of blood glucose compared to one hospital-based education session in the UC group. The outcomes were macrosomia defined as birth weight???4.0 kg and the pregnancy-induced hypertension (PIH).

Results

Women in the SC (n = 339) and UC (n = 361) groups delivered their infants at similar gestational weeks. Birth weight of infants in the SC group was lower than that in the UC group (3469 vs. 3371 grams, P = 0.021). The rate of macrosomia was 11.2% (38/339) in the SC group compared to 17.5% (63/361) in the UC group with relative risk (RR) of 0.64 (95% CI: 0.44-0.93). The rate of PIH was 8.0% (27/339) in the SC compared to 4.4% (16/361) in the UC with RR of 1.80 (0.99-3.28). Apgar score at 1 min?

Conclusions

Lifestyle modifications using a SC system improved pregnancy outcomes in Chinese women with GDM.

Trial registration

Clinicaltrials.gov; NCT01565564 webcite.

【 授权许可】

   
2014 Yang et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Yang X, Hsu-Hage B, Zhang H, Zhang C, Zhang Y, Zhang C: Women with impaired glucose tolerance during pregnancy have significantly poor pregnancy outcomes. Diabetes Care 2002, 25:1619-1624.
• [2]Rosenberg TJ, Garbers S, Lipkind H, Chiasson MA: Maternal obesity and diabetes as risk factors for adverse pregnancy outcomes: differences among 4 racial/ethnic groups. Am J Public Health 2005, 95:1545-1551.
• [3]Weiner CP: Effect of varying degrees of "normal" glucose metabolism on maternal and perinatal outcome. Am J Obstet Gynecol 1988, 159:862-870.
• [4]Hod M, Merlob P, Friedman S, Schoenfeld A, Ovadia J: Gestational diabetes mellitus. A survey of perinatal complications in the 1980s. Diabetes 1991, 40:74-78.
• [5]Maresh M, Beard RW, Bray CS, Elkeles RS, Wadsworth J: Factors predisposing to and outcome of gestational diabetes. Obstet Gynecol 1989, 74:342-346.
• [6]Whitaker RC, Pepe MS, Seidel KD, Wright JA, Knopp RH: Gestational diabetes and the risk of offspring obesity. Pediatrics 1998, 101:E9.
• [7]Feig DS, Zinman B, Wang X, Hux JE: Risk of development of diabetes mellitus after diagnosis of gestational diabetes. CMAJ 2008, 179:229-234.
• [8]Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA: Hyperglycemia and adverse pregnancy outcomes. N Engl J Med 2008, 358:1991-2002.
• [9]Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB: A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med 2009, 361:1339-1348.
• [10]Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med 2005, 352:2477-2486.
• [11]Alberti KG, Zimmet PZ: Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med 1998, 15:539-553.
• [12]Metzger BE, Coustan DR: Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee. Diabetes Care 1998, 21(Suppl 2):B161-B167.
• [13]Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva A, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI: International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care 2010, 33:676-682.
• [14]Morikawa M, Yamada T, Akaishi R, Nishida R, Cho K, Minakami H: Change in the number of patients after the adoption of IADPSG criteria for hyperglycemia during pregnancy in Japanese women. Diabetes Res Clin Pract 2010, 90:339-342.
• [15]O'Sullivan EP, Avalos G, O'Reilly M, Dennedy MC, Gaffney G, Dunne F: Atlantic Diabetes in Pregnancy (DIP): the prevalence and outcomes of gestational diabetes mellitus using new diagnostic criteria. Diabetologia 2011, 54:1670-1675.
• [16]Yang X, Hsu-Hage B, Zhang H, Yu L, Dong L, Li J, Shao P, Zhang C: Gestational diabetes mellitus in women of single gravidity in Tianjin City, China. Diabetes Care 2002, 25:847-851.
• [17]Zhang F, Dong L, Zhang CP, Li B, Wen J, Gao W, Sun S, Lv F, Tian H, Tuomilehto J, Qi L, Zhang CL, Yu Z, Yang X, Hu G: Increasing prevalence of gestational diabetes mellitus in Chinese women from 1999 to 2008. Diabet Med 2011, 28:652-657.
• [18]Tricco AC, Ivers NM, Grimshaw JM, Moher D, Turner L, Galipeau J, Halperin I, Vachon B, Ramsay T, Manns B, Tonelli M, Shojania K: Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis. Lancet 2012, 379:2252-2261.
• [19]So WY, Chan JC: The Role of the Multidisciplinary Team. In Textbook of Diabetes. 4th edition. Edited by Holt R, Cockram S, Flyvbjerg A, Goldstein B. Wiley-Blackwell, Oxford, UK; 2010:969-983.
• [20]Diagnosis and classification of diabetes mellitus Diabetes Care 2010, 33(Suppl 1):S62-S69.
• [21]Chen C, Lu FC: The guidelines for prevention and control of overweight and obesity in Chinese adults. Biomed Environ Sci 2004, 17(Suppl):1-36.
• [22]Zhang Y, Ting R, Lam M, Lam J, Nan H, Yeung R, Yang W, Ji L, Weng J, Wing YK, Sartorius N, Chan JC: Measuring depressive symptoms using the Patient Health Questionnaire-9 in Hong Kong Chinese subjects with type 2 diabetes. J Affect Disord 2013, 151:660-666.
• [23]Yu X, Tam WW, Wong PT, Lam TH, Stewart SM: The Patient Health Questionnaire-9 for measuring depressive symptoms among the general population in Hong Kong. Compr Psychiatry 2012, 53:95-102.
• [24]Nan H, Lee PH, McDowell I, Ni MY, Stewart SM, Lam TH: Depressive symptoms in people with chronic physical conditions: prevalence and risk factors in a Hong Kong community sample. BMC Psychiatry 2012, 12:198. BioMed Central Full Text
• [25]Ma G, Luan D, Li Y, Liu A, Hu X, Cui Z, Zhai F, Yang X: Physical activity level and its association with metabolic syndrome among an employed population in China. Obes Rev 2008, 9(Suppl 1):113-118.
• [26]Fattah C, Farah N, Barry SC, O'Connor N, Stuart B, Turner MJ: Maternal weight and body composition in the first trimester of pregnancy. Acta Obstet Gynecol Scand 2010, 89:952-955.
• [27]Spiegelman D, Hertzmark E: Easy SAS calculations for risk or prevalence ratios and differences. Am J Epidemiol 2005, 162:199-200.
• [28]Meher S, Duley L: Exercise or other physical activity for preventing pre-eclampsia and its complications.Cochrane Database Syst Rev 2006, CD005942.
• [29]Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PM, Damm P, Dyer AR, Hod M, Kitzmiller JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y: The diagnosis of gestational diabetes mellitus: new paradigms or status quo? J Matern Fetal Neonatal Med 2012, 25:2564-2569.
• [30]Holt RI, Coleman MA, McCance DR: The implications of the new International Association of Diabetes and Pregnancy Study Groups (IADPSG) diagnostic criteria for gestational diabetes. Diabet Med 2011, 28:382-385.
• [31]McIntyre HD, Catalano PM: Comment on: Black et al. The relative contribution of prepregnancy overweight and obesity, gestational weight gain, and IADPSG-defined gestational diabetes mellitus to fetal overgrowth. Diabetes Care 2013;36:56¿62. Diabetes Care 2013, 36:e127.
• [32]Black MH, Sacks DA, Xiang AH, Lawrence JM: The relative contribution of prepregnancy overweight and obesity, gestational weight gain, and IADPSG-defined gestational diabetes mellitus to fetal overgrowth. Diabetes Care 2013, 36:56-62.
• [33]Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G: Prevalence and control of diabetes in Chinese adults. JAMA 2013, 310:948-959.
• [34]Marshall M, Pronovost P, Dixon-Woods M: Promotion of improvement as a science. Lancet 2013, 381:419-421.