The IDEAL study: investigation of dietary advice and lifestyle for women with borderline gestational diabetes: a randomised controlled trial - study protocol

BMC Pregnancy and Childbirth

Volumn 12, Issue , 2012, Pages

  Crowther, Caroline A ^a,b   Hague, William M ^a   Middleton, Philippa F ^a   Baghurst, Peter A ^b   McPhee, Andrew J ^c   Tran, Thach S ^a   Yelland, Lisa N ^a   Ashwood, Pat ^a   Han, Shan ^a   Dodd, Jodie M ^a   Robinson, Jeffrey S ^a  

^a UNIVERSITY OF ADELAIDE   (Australia)

^b UNIVERSITY OF ADELAIDE   (Australia)

^c WOMEN S AND CHILDREN S HOSPITAL   (Australia)

Author keywords

Borderline gestational diabetes; Diet; Gestational diabetes mellitus; Large for gestational age; Lifestyle; Randomised controlled trial

Indexed keywords

ARTICLE; BLOOD GLUCOSE MONITORING; CLINICAL PRACTICE; CONTROLLED STUDY; FEMALE; FOLLOW UP; GESTATIONAL AGE; GLUCOSE BLOOD LEVEL; HUMAN; HYPERGLYCEMIA; INFORMED CONSENT; LIFESTYLE MODIFICATION; MATERNAL MORBIDITY; MATERNAL NUTRITION; MULTICENTER STUDY; NEWBORN DISEASE; OBSTETRIC PROCEDURE; ORAL GLUCOSE TOLERANCE TEST; PREGNANCY DIABETES MELLITUS; PREGNANT WOMAN; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL;

ADULT; DIABETES, GESTATIONAL; DIET; FEMALE; FETAL MACROSOMIA; GLUCOSE TOLERANCE TEST; HUMANS; INFANT, NEWBORN; LIFE STYLE; PATIENT EDUCATION AS TOPIC; PREGNANCY;

EID: 84867135313     PISSN: None     EISSN: 14712393     Source Type: Journal    
DOI: 10.1186/1471-2393-12-106     Document Type: Article

References (47)

1. Dabelea D, Snell-Bergeon JK, Hartsfield CL, Bischoff KJ, Hamman RF, McDuffie RS. Increasing prevalence of gestational diabetes mellitus (GDM) over time and by birth cohort - Kaiser permanente of Colorado GDM screening program. Diabetes Care 2005, 28(3):579-584. 10.2337/diacare.28.3.579, 15735191.
2. American College of Obstetricians and Gynecologists ACOG Practice Bulletin. Clinical management guidelines for obstetricians-gynecologists. Number 55, September 2004 (replaces practice pattern number 6, October 1997). Management of Postterm Pregnancy. Obstet Gynecol 2004, 104(3)):639-646. American College of Obstetricians and Gynecologists.
3. Cheung NW, Byth K. Population health significance of gestational diabetes. Diabetes Care 2003, 26(7):2005-2009. 10.2337/diacare.26.7.2005, 12832303.
4. Robson S, Chan A, Keane RJ, Luke CG. Subsequent birth outcomes after an unexplained stillbirth: preliminary population-based retrospective cohort study. Aust Nz J Obstet Gyn 2001, 41(1):29-35.
5. Innes KE, Byers TE, Marshall JA, Baron A, Orleans M, Hamman RF. Association of a woman's own birth weight with subsequent risk for gestational diabetes. JAMA 2002, 287(19):2534-2541. 10.1001/jama.287.19.2534, 12020334.
6. Dea P. GDM and impaired glucose tolerance during pregnancy: long-term effects on obesity and glucose intolerance in the offspring. Diabetes Care 1985, 34:119-122.
7. Rumbold AR, Crowther CA, Haslam RR, Dekker GA, Robinson JS. Vitamins C and E and the risks of preeclampsia and perinatal complications. New Engl J Med 2006, 354(17):1796-1806. 10.1056/NEJMoa054186, 16641396.
8. Dodd JM, Crowther CA, Antoniou G, Baghurst P, Robinson JS. Screening for gestational diabetes: The effect of varying blood glucose definitions in the prediction of adverse maternal and infant health outcomes. Aust Nz J Obstet Gyn 2007, 47(4):307-312.
9. Laws PJ, Sullivan EA. Australia's mother's and babies 2003. Perinatal Statistics Series Number 16. Cat. No. PER 29 2005, AIHW National Perinatal Statistics Unit, Sydney.
10. Acker DB, Sachs BP, Friedman EA. Risk-Factors for Shoulder Dystocia. Obstet Gynecol 1985, 66(6):762-768.
11. Langer O, Yogev Y, Most O, Xenakis EM. Gestational diabetes: the consequences of not treating. Am J Obstet Gynecol 2005, 192(4):989-997. 10.1016/j.ajog.2004.11.039, 15846171.
12. Langer O, Rodriguez DA, Xenakis MJ, Mcfarland MB, Berkus MD, Arredondo F. Intensified Versus Conventional Management of Gestational Diabetes. Am J Obstet Gynecol 1994, 170(4):1036-1047.
13. Soler NG, Malins JM. Neonatal Morbidity Amongst Infants of Diabetics. Diabetes 1978, 27:464-464.
14. Forman MR, Cantwell MM, Ronckers C, Zhang YW. Through the looking glass at early-life exposures and breast cancer risk. Cancer Invest 2005, 23(7):609-624. 10.1080/07357900500283093, 16305989.
15. Silverman BL, Rizzo TA, Cho NH, Metzger BE. Long-term effects of the intrauterine environment. The Northwestern University Diabetes in Pregnancy Center. Diabetes Care 1998, 21(Suppl 2):B142-B149.
16. Rizzo TA, Metzger BE, Dooley SL, Cho NH. Early malnutrition and child neurobehavioral development: Insights from the study of children of diabetic mothers. Child Dev 1997, 68(1):26-38. 10.2307/1131922, 9084122.
17. Silverman BL, Metzger BE, Cho NH, Loeb CA. Impaired glucose tolerance in adolescent offspring of diabetic mothers. Relationship to fetal hyperinsulinism. Diabetes Care 1995, 18(5):611-617. 10.2337/diacare.18.5.611, 8585997.
18. Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS, . ACHOIS Trial Group Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. New Engl J Med 2005, 352(24):2477-2486. 10.1056/NEJMoa042973, 15951574, ACHOIS Trial Group.
19. Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM, et al. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med 2009, 361(14):1339-1348. 10.1056/NEJMoa0902430, 2804874, 19797280.
20. Kim C, Newton KM, Knopp RH. Gestational diabetes and the incidence of type 2 diabetes: a systematic review. Diabetes Care 2002, 25(10):1862-1868. 10.2337/diacare.25.10.1862, 12351492.
21. Sermer M, Naylor CD, Gare DJ, Kenshole AB, Ritchie JWK, Farine D, Cohen HR, Mcarthur K, Holzapfel S, Biringer A, et al. Impact of Increasing Carbohydrate Intolerance on Maternal-Fetal Outcomes in 3637 Women without Gestational Diabetes - the Toronto Tri-Hospital Gestational Diabetes Project. Am J Obstet Gynecol 1995, 173(1):146-156. 10.1016/0002-9378(95)90183-3, 7631672.
22. Sermer M, Naylor CD, Farine D, Kenshole AB, Ritchie JWK, Gare DJ, Cohen HR, McArthur K, Holzapfel S, Biringer A, et al. The Toronto Tri-Hospital Gestational Diabetes Project - A preliminary review. Diabetes Care 1998, 21:B33-B42.
23. Yogev Y, Xenakis EMJ, Langer O. The association between preeclampsia and the severity of gestational diabetes: The impact of glycemic control. Am J Obstet Gynecol 2004, 191(5):1655-1660. 10.1016/j.ajog.2004.03.074, 15547538.
24. HAPO Study Group Hyperglycemia and adverse pregnancy outcome. New Engl J Med 2008, 358:1991-2002. HAPO Study Group.
25. Moss JR, Crowther CA, Hiller JE, Willson KJ, Robinson JS. Costs and consequences of treatment for mild gestational diabetes mellitus - evaluation from the ACHOIS randomised trial. BMC Pregnancy Childbirth 2007, 7:27. 10.1186/1471-2393-7-27, 2241640, 17963528.
26. Greene MF, Solomon CG. Gestational diabetes mellitus - time to treat. N Engl J Med 2005, 352(24):2544-2546. 10.1056/NEJMe058100, 15951575.
27. McIntyre HD, Cheung NW, Oats JJ, Simmons D. Gestational diabetes mellitus: from consensus to action on screening and treatment. Med J Aust 2005, 183(6):288-289.
28. Fraser R. Gestational diabetes: after the ACHOIS trial. Diabet Med 2006, 23(Suppl 1):8-11.
29. Simmons D, Wolmarans L, Cutchie W, Johnson E, Haslam A, Roodt C, Rowan J. Gestational diabetes mellitus: time for consensus on screening and diagnosis. N Z Med J 2006, 119(1228):U1807.
30. Tuffnell D, West J, Walkinshaw S. Time to screen for, and treat, gestational diabetes. BJOG 2006, 113(1):3-4.
31. Han S, Crowther CA, Middleton P. Interventions for pregnant women with hyperglycaemia not meeting gestational diabetes and type 2 diabetes diagnostic criteria. Cochrane Database Syst Rev 2012, 1:CD009037.
32. Bonomo M, Corica D, Mion E, Goncalves D, Motta G, Merati R, Ragusa A, Morabito A. Evaluating the therapeutic approach in pregnancies complicated by borderline glucose intolerance: a randomized clinical trial. Diabet Med 2005, 22(11):1536-1541. 10.1111/j.1464-5491.2005.01690.x, 16241919.
33. Bevier WC, Fischer R, Jovanovic L. Treatment of women with an abnormal glucose challenge test (but a normal oral glucose tolerance test) decreases the prevalence of macrosomia. Am J Perinatol 1999, 16(6):269-275. 10.1055/s-2007-993871, 10586979.
34. Grant SM, Wolever TM, O'Connor DL, Nisenbaum R, Josse RG. Effect of a low glycaemic index diet on blood glucose in women with gestational hyperglycaemia. Diabetes Res Clin Pract 2011, 91(1):15-22. 10.1016/j.diabres.2010.09.002, 21094553.
35. Langer O, Anyaegbunam A, Brustman L, Divon M. Management of women with one abnormal oral glucose tolerance test value reduces adverse outcome in pregnancy. Am J Obstet Gynecol 1989, 161(3):593-599.
36. Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (Sf-36). Conceptual-Framework and Item Selection. Med Care 1992, 30(6):473-483. 10.1097/00005650-199206000-00002, 1593914.
37. Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol 1992, 31(Pt 3):301-306.
38. Cox JL, Holden JM, Sagovsky R. Detection of Postnatal Depression - Development of the 10-Item Edinburgh Postnatal Depression Scale. Br J Psychiatry 1987, 150:782-786. 10.1192/bjp.150.6.782, 3651732.
39. Wendel-Vos GC, Schuit AJ, Saris WH, 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, 14680666.
40. Willett WC, Sampson L, Stampfer MJ, Rosner B, Bain C, Witschi J, Hennekens CH, Speizer FE. Reproducibility and validity of a semiquantitative food frequency questionnaire. Am J Epidemiol 1985, 122(1):51-65.
41. Gillies CL, Abrams KR, Lambert PC, Cooper NJ, Sutton AJ, Hsu RT, Khunti K. Pharmacological and lifestyle interventions to prevent or delay type 2 diabetes in people with impaired glucose tolerance: systematic review and meta-analysis. Brit Med J 2007, 334(7588):299-302B. 10.1136/bmj.39063.689375.55, 1796695, 17237299.
42. Hoffman L, Nolan C, Wilson JD, Oats JJN, Simmons D. Gestational diabetes mellitus - management guidelines - The Australasian Diabetes in Pregnancy Society. Med J Australia 1998, 169(2):93-97.
43. Beeby PJ, Bhutap T, Taylor LK. New South Wales population-based birthweight percentile charts. J Paediatr Child H 1996, 32(6):512-518.
44. Donoghue DA, Cust AE. Australian and New Zealand Neonatal Network 1998 2000, AIHW National Perinatal Statistics Unit, Sydney.
45. Hannah ME, Hannah WJ, Hellmann J, Hewson S, Milner R, Willan A. Induction of Labor as Compared with Serial Antenatal Monitoring in Postterm Pregnancy - a Randomized Controlled Trial. New Engl J Med 1992, 326(24):1587-1592. 10.1056/NEJM199206113262402, 1584259.
46. Sarnat HB, Sarnat MS. Neonatal Encephalopathy Following Fetal Distress - Clinical and Electroencephalographic Study. Arch Neurol-Chicago 1976, 33(10):696-705. 10.1001/archneur.1976.00500100030012, 987769.
47. Brown MA, Hague WM, Higgins J, Lowe S, McCowan L, Oats J, Peek MJ, Rowan JA, Walters BN. The detection, investigation and management of hypertension in pregnancy: full consensus statement. Aust N Z J Obstet Gynaecol 2000, 40(2):139-155. 10.1111/j.1479-828X.2000.tb01137.x, 10925900.