A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: Design and rationale of the Gestational Diabetes' Effects on Moms (GEM) study

BMC Pregnancy and Childbirth

Volumn 14, Issue 1, 2014, Pages

  Ferrara, Assiamira ^a   Hedderson, Monique M ^a   Albright, Cheryl L ^b   Brown, Susan D ^a   Ehrlich, Samantha F ^a   Caan, Bette J ^a   Sternfeld, Barbara ^a   Gordon, Nancy P ^a   Schmittdiel, Julie A ^a   Gunderson, Erica P ^a   Mevi, Ashley A ^a   Tsai, Ai Lin ^a   Ching, Jenny ^c   Crites, Yvonne ^c   Quesenberry Jr, Charles P ^a  

^a DIVISION OF RESEARCH   (United States)

^b UNIVERSITY OF HAWAII   (United States)

^c KAISER PERMANENTE MEDICAL CENTER   (United States)

Author keywords

Cluster randomized clinical trial; Comparative effectiveness; Diabetes prevention; GDM; Lifestyle intervention

Indexed keywords

FAT; GLUCOSE;

ADULT; ARTICLE; BLOOD PRESSURE; CALORIC INTAKE; CALORIE; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DEPRESSION; ELECTRONIC MEDICAL RECORD; FEMALE; GLUCOSE BLOOD LEVEL; HEALTH CARE PRACTICE; HEALTH CARE SYSTEM; HEALTH PROGRAM; HEALTH SURVEY; HUMAN; LIFESTYLE MODIFICATION; MAJOR CLINICAL STUDY; MIDDLE AGED; MULTICENTER STUDY; OUTCOME ASSESSMENT; PHYSICAL ACTIVITY; POSTAL MAIL; PREGNANCY DIABETES MELLITUS; PREGNANT WOMAN; PUERPERIUM; RANDOMIZED CONTROLLED TRIAL; TELEPHONE; UNITED STATES; WEIGHT CHANGE; WEIGHT CONTROL; YOUNG ADULT;

ADOLESCENT; ADULT; BLOOD GLUCOSE; BODY MASS INDEX; CALIFORNIA; DIABETES MELLITUS, TYPE 2; DIABETES, GESTATIONAL; DIET; DIRECTIVE COUNSELING; FEMALE; HEALTH PROMOTION; HUMANS; HYPOGLYCEMIC AGENTS; LIFE STYLE; MOTOR ACTIVITY; PATIENT EDUCATION AS TOPIC; POSTNATAL CARE; PREGNANCY; PRENATAL CARE; RESEARCH DESIGN; TELEPHONE; WEIGHT GAIN; YOUNG ADULT;

EID: 84892882774     PISSN: None     EISSN: 14712393     Source Type: Journal    
DOI: 10.1186/1471-2393-14-21     Document Type: Article

References (42)

1. Metzger BE. Summary and recommendations of the third international workshop- conference on gestational diabetes mellitus. Diabetes 1991, 40(Suppl 2):197-201.
2. Ferrara A, Kahn HS, Quesenberry C, Riley C, Hedderson MM. An increase in the incidence of gestational diabetes mellitus: Northern California, 1991-2000. Obstet Gynecol 2004, 103:526-533. 10.1097/01.AOG.0000113623.18286.20, 14990417.
3. Bellamy L, Casas JP, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet 2009, 373:1773-1779. 10.1016/S0140-6736(09)60731-5, 19465232.
4. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002, 346:393-403. 1370926, 11832527.
5. Ratner RE, Christophi CA, Metzger BE, Dabelea D, Bennett PH, Pi-Sunyer X, Fowler S, Kahn SE. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab 2008, 93:4774-4779. 10.1210/jc.2008-0772, 2626441, 18826999.
6. Kim C, McEwen LN, Kerr EA, Piette JD, Chames MC, Ferrara A, Herman WH. Preventive counseling among women with histories of gestational diabetes mellitus. Diabetes Care 2007, 10:2489-2495.
7. Ferrara A, Peng T, Kim C. Trends in postpartum diabetes screening and subsequent diabetes and impaired fasting glucose among women with histories of gestational diabetes mellitus. A report from the translating research into action for diabetes (TRIAD) study. Diabetes Care 2009, 32(2):269-274. Doi: 10.2337/dc08-1184, 2628692, 18984776.
8. Ferrara A, Hedderson M, Albright CL, Ehrlich SF, Quesenberry CP, Peng T, Feng J, Ching J, Crites YM. A pregnancy and postpartum lifestyle intervention in women with GDM reduces diabetes risk factors: a feasibility randomized control trial. Diabetes Care 2011, 34:1519-1525. 10.2337/dc10-2221, 3120183, 21540430.
9. Ferrara A, Hedderson MM, Ching J, Kim C, Peng T, Crites YM. Referral to telephonic nurse management improves outcomes in women with gestational diabetes. Am J Obstet Gynecol 2012, 206:491-495. 3365516, 22631866.
10. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health 1999, 89:1322-1327. 10.2105/AJPH.89.9.1322, 1508772, 10474547.
11. Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001, 285:2370-2375. 10.1001/jama.285.18.2370, 11343485.
12. Committee opinion no. 504: screening and diagnosis of gestational diabetes mellitus. Obstet Gynecol 2011, 118:751-753. 10.1097/AOG.0b013e3182310cc3, 21860317.
13. Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol 1982, 144:768-773.
14. American Diabetes Association Standards of medical care in diabetes--2013. Diabetes Care 2013, 36(Suppl 1):S11-S66. 3537269, 23264422, American Diabetes Association.
15. Hayes RJ, Moulton LH. Cluster Randomzed Trial 2009, Chapman & Hall/CRC: Boca Raton.
16. SAS Institute Inc SAS software 9.3 2013, NC, USA: Cary, SAS Institute Inc.
17. The Diabetes Prevention Program (DPP): Research Group Description of lifestyle intervention. Diabetes Care 2002, 25:2165-2171. 1282458, 12453955, The Diabetes Prevention Program (DPP): Research Group.
18. Bandura A. Social Foundations of Thought and Action: A social cognitive theory 1986, N.J, Prentice Hall: Englewood Cliffs.
19. Prochaska JO, DiClemente CC. Common processes of self-change in smoking, weight control and psychological distress. Coping and Substance Use 1985, 345-363. New York: Academic Press, Shiffman S, Wills T.
20. Albright CL, Steffen AD, Novotny R, Nigg CR, Wilkens LR, Saiki K, Yamada P, Hedemark B, Maddock JE, Dunn AL, Brown WJ. Baseline results from Hawaii's Na Mikimiki Project: a physical activity intervention tailored to multiethnic postpartum women. Women Health 2012, 52:265-291. 10.1080/03630242.2012.662935, 3379789, 22533900.
21. Marcus BH, Simkin LR. The stages of exercise behavior. J Sports Med Phys Fitness 1993, 33:83-88.
22. Kristal AR, Glanz K, Curry SJ, Patterson RE. How can stages of change be best used in dietary interventions?. J Am Diet Assoc 1999, 99:679-684. 10.1016/S0002-8223(99)00165-0, 10361529.
23. Chang MW, Nitzke S, Brown RL, Baumann LC, Oakley L. Development and validation of a self-efficacy measure for fat intake behaviors of low-income women. J Nutr Educ Behav 2003, 35:302-307. 10.1016/S1499-4046(06)60344-8, 14642215.
24. Kiernan M, Moore SD, Schoffman DE, Lee K, King AC, Taylor CB, Kiernan NE, Perri MG. Social support for healthy behaviors: scale psychometrics and prediction of weight loss among women in a behavioral program. Obesity (Silver Spring) 2012, 20:756-764. 10.1038/oby.2011.293, 21996661.
25. IOM (Institutes of Medicine) Weight Gain During Pregnancy: Reexamining the Guidelines 2009, Washington DC: The National Academic Press, IOM (Institutes of Medicine).
26. Borrelli B, Sepinwall D, Ernst D, Bellg AJ, Czajkowski S, Breger R, DeFrancesco C, Levesque C, Sharp DL, Ogedegbe G, Resnick B, Orwig D. A new tool to assess treatment fidelity and evaluation of treatment fidelity across 10 years of health behavior research. J Consult Clin Psychol 2005, 73:852-860.
27. Phinney JS, Ong AD. Conceptualization and measurement of ethnic identity. J Couns Psychol 2007, 54:271-281.
28. Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord 2009, 114:163-173. 10.1016/j.jad.2008.06.026, 18752852.
29. Block G, Gillespie C, Rosenbaum EH, Jenson C. A rapid food screener to assess fat and fruit and vegetable intake. Am J Prev Med 2000, 18:284-288. 10.1016/S0749-3797(00)00119-7, 10788730.
30. Block G, Hartman AM, Dresser CM, Carroll MD, Gannon J, Gardner L. A data-based approach to diet questionnaire design and testing. Am J Epidemiol 1986, 124:453-469.
31. Brown WJ, Bauman AE. Comparison of estimates of population levels of physical activity using two measures. Aust N Z J Public Health 2000, 24:520-525. 10.1111/j.1467-842X.2000.tb00503.x, 11109690.
32. Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS. Development and validation of a pregnancy physical activity questionnaire. Med Sci Sports Exerc 2004, 36:1750-1760. 10.1249/01.MSS.0000142303.49306.0D, 15595297.
33. Gunderson EP, Matias SL, Hurston SR, Dewey KG, Ferrara A, Quesenberry CP, Lo JC, Sternfeld B, Selby JV. Study of women, infant feeding, and type 2 diabetes mellitus after GDM pregnancy (SWIFT), a prospective cohort study: methodology and design. BMC Public Health 2011, 11:952. 10.1186/1471-2458-11-952, 3295844, 22196129.
34. Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med 2004, 36:588-594.
35. Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care 2005, 43:203-220. 10.1097/00005650-200503000-00003, 15725977.
36. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav 1983, 24:385-396. 10.2307/2136404, 6668417.
37. Kim C, McEwen LN, Piette JD, Goewey J, Ferrara A, Walker EA. Risk perception for diabetes among women with histories of gestational diabetes mellitus. Diabetes Care 2007, 30:2281-2286. 10.2337/dc07-0618, 17575087.
38. Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ 2012, 345:e5661. 10.1136/bmj.e5661, 22951546.
39. Eldridge SM, Ashby D, Feder GS. Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care. Clin Trials 2005, 2:91-98. 10.1191/1740774505cn070oa, 16279130.
40. Kim C, Newton KM, Knopp RH. Gestational diabetes and the incidence of type 2 diabetes: a systematic review. Diabetes Care 2002, 25:1862-1868. 10.2337/diacare.25.10.1862, 12351492.
41. Nicholson WK, Wilson LM, Witkop CT, Baptiste-Roberts K, Bennett WL, Bolen S, Barone BB, Golden SH, Gary TL, Neale DM, Bass EB. Therapeutic management, delivery, and postpartum risk assessment and screening in gestational diabetes. Evid Rep Technol Assess (Full Rep) 2008, 162:1-96.
42. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003, 290:1624-1632.