BMC Pregnancy and Childbirth | |
Primary prevention of gestational diabetes for women who are overweight and obese: a randomised controlled trial | |
Richard L Kennedy5  Peter Mayall6  Bodil Rasmussen1  Alison Nankervis2  Heather Morris3  Helen Skouteris3  Cate Nagle4  | |
[1] School of Nursing and Midwifery, Deakin University, 221 Burwood Highway, Burwood 3125, Victoria, Australia;Royal Melbourne Hospital, Melbourne, Australia;School of Psychology, Burwood campus, 221 Burwood Hwy, Burwood, Victoria 3125, Australia;School of Nursing and Midwifery, Deakin University, Geelong Waterfront campus, Locked bag 20000, Geelong, Victoria 3220, Australia;School of Medicine, Deakin University, Geelong Waurn Ponds campus, 75 Pidgons Road Waurn Ponds, Geelong, Victoria 3216, Australia;Department of Obstetrics and Gynaecology, Barwon Health, Ryrie St, Geelong 3215 Victoria, Australia | |
关键词: RCT; Primary care; Gestational weight gain; Prevention; Obesity; Gestational diabetes; | |
Others : 1138145 DOI : 10.1186/1471-2393-13-65 |
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received in 2013-02-01, accepted in 2013-02-26, 发布年份 2013 | |
【 摘 要 】
Background
Gestational Diabetes Mellitus (GDM) has well recognised adverse health implications for the mother and her newborn that are both short and long term. Obesity is a significant risk factor for developing GDM and the prevalence of obesity is increasing globally. It is a matter of public health importance that clinicians have evidence based strategies to inform practice and currently there is insufficient evidence regarding the impact of dietary and lifestyle interventions on improving maternal and newborn outcomes. The primary aim of this study is to measure the impact of a telephone based intervention that promotes positive lifestyle modifications on the incidence of GDM. Secondary aims include: the impact on gestational weight gain; large for gestational age babies; differences in blood glucose levels taken at the Oral Glucose Tolerance Test (OGTT) and selected factors relating to self-efficacy and psychological wellbeing.
Method/design
A randomised controlled trial (RCT) will be conducted involving pregnant women who are overweight (BMI >25 to 29.9 k/gm2) or obese (BMI >30 kgm/2), less than 14 weeks gestation and recruited from the Barwon South West region of Victoria, Australia. From recruitment until birth, women in the intervention group will receive a program informed by the Theory of Self-efficacy and employing Motivational Interviewing. Brief ( less than 5 minute) phone contact will alternate with a text message/email and will involve goal setting, behaviour change reinforcement with weekly weighing and charting, and the provision of health information. Those in the control group will receive usual care. Data for primary and secondary outcomes will be collected from medical record review and a questionnaire at 36 weeks gestation.
Discussion
Evidence based strategies that reduce the incidence of GDM are a priority for contemporary maternity care. Changing health behaviours is a complex undertaking and trialling a composite intervention that can be adopted in various primary health settings is required so women can be accessed as early in pregnancy as possible. Using a sound theoretical base to inform such an intervention will add depth to our understanding of this approach and to the interpretation of results, contributing to the evidence base for practice and policy.
Trial registration
This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000125729
【 授权许可】
2013 Nagle et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
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20150318214400779.pdf | 199KB | download |
【 参考文献 】
- [1]Flack JR, Ross GP, Ho S, McElduff A: Recommended changes to diagnostic criteria for gestational diabetes: Impact on workload. Aust N Z J Obstet Gynaecol 2010, 50(5):439-43.
- [2]McIntyre HD, Gibbons KS, Flenady VJ, Callaway LK: Overweight and obesity in Australian mothers: epidemic or endemic? Med J Aust 2012, 196(3):184-8.
- [3]Moses RG, Morris GJ, Petocz P, Gil FS, Garg D: The impact of potential new diagnostic criteria on the prevalence of gestational diabetes mellitus in Australia. Med J Aust 2011, 194(7):338-40.
- [4]Shand AW, Bell JC, McElduff A, Morris J, Roberts CL: Outcomes of pregnancies in women with pre-gestational diabetes mellitus and gestational diabetes mellitus; a population-based study in New South Wales, Australia, 1998–2002. Diabet Med 2008, 25(6):708-15.
- [5]Clausen TD, Mathiesen ER, Hansen T, Pedersen O, Jensen DM, Lauenborg J: Overweight and the metabolic syndrome in adult offspring of women with diet-treated gestational diabetes mellitus or type 1 diabetes. J Clin Endocrinol Metab 2009, 94(7):2464-2470. [Comparative Study Research Support, Non-U.S. Gov't]
- [6]Cunningham CE, Teale GR: A profile of body mass index in a large rural Victorian obstetric cohort. Med J Aust 2013, 198(1):39-42.
- [7]LaCoursiere DB, Duncan L, Varner M: Population-based trends and correlates of maternal overweight and obesity, Utah 1991–2001. Am J Obstet Gynecol 2005, 192(3):832-9.
- [8]Ramachenderan J, Bradford J, McLean M, Ramachenderan J, Bradford J, McLean M: Maternal obesity and pregnancy complications: a review. Australian & New Zealand. J Obstet Gynaecol 2008, 48(3):228-235. [Review]
- [9]Freedman DS, Dietz WH, Srinivasan SR, Berenson GS: The Relation of Overweight to Cardiovascular Risk Factors Among Children and Adolescents: The Bogalusa Heart Study. Pediatrics 103, 103(6):1175-1182.
- [10]Yogev Y, Visser GHA: Obesity, gestational diabetes and pregnancy outcome. Semin Fetal Neonatal Med 2009, 14(2):77-84.
- [11]Callaway L, Chang A, McIntrye H, Prins J: The prevalance and imact of overweight and obesity in an Australian obstetric population. Med J Aust 2006, 184(2):56-9.
- [12]Cnattingius S, Bergstrom R, Lipworth L, Kramer MS: Prepregnancy Weight and the Risk of Adverse Pregnancy Outcomes. N Engl J Med 1998, 338(3):147-152.
- [13]Galtier-Dereure F, Boegner C, Bringer J: Obesity and pregnancy: complications and cost. Am J Clin Nutr 2000, 71:1242S-8S.
- [14]Catalano PM, Ehrenberg HM: The short- and long-term implications of maternal obesity on the mother and her offspring. BJOG 2006, 113(10):1126-33.
- [15]Athukorala C, Rumbold AR, Wilson KJ, Crowther C: The risk of adverse pregnancy outcomes in women who are overweight or obese. BMC Pregnancy & Childbirth 2010., 10 BioMed Central Full Text
- [16]Dodd JM, Grivell RM, Nguyen A-M, Chan A, Robinson JS: Maternal and perinatal health outcomes by body mass index category. Aust N Z J Obstet Gynaecol 2011, 51(2):136-40.
- [17]Doherty DA, Magann EF, Francis J, Morrison JC, Newnham JP: Pre-pregnancy body mass index and pregnancy outcomes. Int J Gynaecol Obstet 2006, 95(3):242-247. [Research Support, Non-U.S. Gov't]
- [18]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(24):2477-86.
- [19]Kiran T, Hemmadi S, Bethel J, Evans J: Outcome of pregnancy in a woman with an increased body mass index. BJOG 2005, 112(6):768-72.
- [20]Kristensen J, Vestergaard M, Wisborg K, Kesmodel U, Secher NJ, Kristensen J: Pre-pregnancy weight and the risk of stillbirth and neonatal death. BJOG 2005, 112(4):403-408. [Research Support, Non-U.S. Gov't]
- [21]Sebire N, Jolly M, Harris J, Wadsworth J, Joffe M, Beard R: Maternal obesity and pregnancy outcome: a study of 287,213 pregnancies in London. Int J Obes Relat Metab Disord 2001, 25(8):1175-82.
- [22]Cedergren MI: Maternal Morbid Obesity and the Risk of Adverse Pregnancy Outcome. Obstet Gynecol Surv 2004, 59(7):489-91.
- [23]Nohr E, Bech B, Davies M, Frydenberg M, Henriksen T, Olsen J: Prepregnancy obesity and fetal death: a study within the Danish National Birth Cohort. Obstet Gynaecol 2005, 106:250-9.
- [24]Abenhaim HA, Kinch RA, Morin L, Benjamin A, Usher R: Effect of prepregnancy body mass index categories on obstetrical and neonatal outcomes. Arch Gynecol Obstet 2007, 275(1):39-43.
- [25]Rosenberg TJ, Garbers S, Chavkin W, Chiasson MA, Rosenberg TJ, Garbers S: Prepregnancy weight and adverse perinatal outcomes in an ethnically diverse population. Obstet Gynecol 2003, 102(5 Pt 1):1022-7.
- [26]Janus ED, Laatikainen T, Dunbar JA, Kilkkinen A: Overweight, obesity and metabolic syndrome in rural southeastern Australia. Med J Aust 2007, 187(3):147-52.
- [27]World Health Organization: Non communicable diseases: country profiles. Geneva: WHO; 2011.
- [28]Skouteris H, Hartley-Clark L, McCabe M, Milgrom J, Kent B, Herring S: Preventing excessive gestational weight gain: A systematic review of interventions. Obes Rev 2010, 11:757-68.
- [29]Institute of Medicine: Weight Gain During Pregnancy: Reexamining the Guidelines Massachusetts National Academy of Science. 2009. Washington: National Academies Press
- [30]Maternity and Newborn Clinical Network: Care of the obese pregnant woman and Weight Management in Pregnancy. Melbourne, Victoria, Australia; 2011.
- [31]Queensland Statewide Maternity and Neonatal Clinical Guideline: : Obesity. Brisbane(http://www.health.qld.gov.au/cpic/documents/mguideg_obesityv4.0.pdf webcite)
- [32]Asbee SM, Jenkins TR, Butler JR, White J, Elliot M, Rutledge A: Preventing excessive weight gain during pregnancy through dietary and lifestyle counseling: a randomized controlled trial. Obstet Gynecol 2009, 113(2 Pt 1):305-12.
- [33]Claesson IM, Sydsjo G, Brynhildsen J, Cedergren M, Jeppsson A, Nystrom F: Weight gain restriction for obese pregnant women: a case–control intervention study. BJOG 2008, 115(1):44-50.
- [34]Olson C, Stawderman M, Reed R: Efficacy of an intervention to prevent excessive weight gain in pregnant women. Am J Obstet Gynecol 2004, 191:530-6.
- [35]Polley BA, Wing RR, Sims CJ: Randomized controlled trial to prevent excessive weight gain in pregnant women. Int J Obes Relat Metab Disord 2002, 26(11):1494. [Article]
- [36]Kinnunen TI, Pasanen M, Aittasalo M, Fogelholm M, Hilakivi-Clarke L, Weiderpass E: Preventing excessive weight gain during pregnancy – a controlled trial in primary health care. Eur J Clin Nutr 2007, 61(7):884-91. Article
- [37]Olson CM: Achieving a Healthy Weight Gain During Pregnancy. Annual Review of Nutrition. 2008, 28(1):411-23. [Article]
- [38]Dodd JM, Grivell RM, Crowther CA, Robinson JS: Antenatal interventions for overweight or obese pregnant women: a systematic review of randomised trials. BJOG 2010., 29
- [39]Luoto R, Kinnunen TI, Aittasalo M, Kolu P, Raitanen J, Ojala K: Primary Prevention of Gestational Diabetes Mellitus and Large-for-Gestational-Age Newborns by Lifestyle Counseling: A Cluster-Randomized Controlled Trial. PLoS Medicine 2011, 8(5):1-11. [Article]
- [40]Quinlivan JA, Lam LT, Fisher J, Quinlivan JA, Lam LT, Fisher J: A randomised trial of a four-step multidisciplinary approach to the antenatal care of obese pregnant women. Aust N Z J Obstet Gynaecol 2011, 51(2):141-6. [Randomized Controlled Trial Research Support, Non-U.S. Gov't]
- [41]Stafne SN, Salvesen KÅ, Romundstad PR, Eggebø TM, Carlsen SM, Mørkved S: Regular Exercise During Pregnancy to Prevent Gestational Diabetes. Obstetrics 2012, 119(1):29-36. [Article]
- [42]Bandura A: Self efficacy: The exercise of control. New York: Freeman; 1997.
- [43]Miller W, Rollick S: Motivational Interviewing: Preparing people for change. New York: Guilford; 2002.
- [44]Moher D, Schulz KF, Altman DG, Consort: The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol 2001, 1:2. [Research Support, Non-U.S. Gov't] BioMed Central Full Text
- [45]Hoffman L, Nolan C, Wilson J, Oats J, Simmons D: Gestational diabetes mellitus–management guidelines. Australas Diab Pregnancy Soc Med J Aust 1998, 169(2):93-97.
- [46]International Association of Diabetes and Pregnancy Study Groups Consensus Panel' International Association of Diabetes and Pregnancy Study Groups: Recommendations on the Diagnosis and Classification of Hyperglycemia in Pregnancy. Diabetes Care 2010, 33(3):676-682.
- [47]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, 31:301-6.
- [48]Beck A, Steer R, Brown G: BDI-II Beck depression inventory: manual. 2nd edition. Boston: Harcourt Brace; 1996.
- [49]Holcomb W, Stone L, Lustman P, Gavard J, Mostello D: Screening for Depression in Pregnancy: Characteristics of the Beck Depression Inventory. Obstet Gynecol 1996, 88(6):1021-5.
- [50]Clark MM, Abrams DB, Niaura RS, Eaton CA, Rossi JS: Self-efficacy in weight management. J Consult Clin Psychol 1991, 59(5):739-44.
- [51]Resnick B, Jenkins LS: Testing the Reliability and Validity of the Self-Efficacy for Exercise Scale. Nurs Res 2000, 49(3):154-9.
- [52]Rollnick S, Heather N, Gold R, Hall W: Development of a short ‘readiness to change’ questionnaire for use in brief, opportunistic interventions among excessive drinkers. Br J Addict 1992, 87(5):743-54.
- [53]Kinnunen T, Aittasalo M, Koponen P, Ojala K, Mansikkamäki K, Weiderpass E: Feasibility of a controlled trial aiming to prevent excessive pregnancy-related weight gain in primary health care. BMC Pregnancy Childbirth 2008., 8(37) BioMed Central Full Text