Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial - study protocol

Lisa Chasan-Taber, Bess H Marcus, Milagros C Rosal, Katherine L Tucker, Sheri J Hartman, Penelope Pekow, Barry Braun, Tiffany A Moore Simas, Caren G Solomon, Joann E Manson, Glenn Markenson, Lisa Chasan-Taber, Bess H Marcus, Milagros C Rosal, Katherine L Tucker, Sheri J Hartman, Penelope Pekow, Barry Braun, Tiffany A Moore Simas, Caren G Solomon, Joann E Manson, Glenn Markenson

Abstract

Background: Diabetes and obesity have reached epidemic proportions in the U.S. with rates consistently higher among Hispanics as compared to non-Hispanic whites. Among Hispanic women diagnosed with gestational diabetes mellitus (GDM), 50% will go on to develop type 2 diabetes within 5 years of the index pregnancy. Although randomised controlled trials among adults with impaired glucose tolerance have shown that diet and physical activity reduce the risk of type 2 diabetes, such programs have not been tested in high-risk postpartum women. The overall goal of this randomised controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy.

Methods/design: Hispanic pregnant women who screen positive for GDM will be recruited and randomly assigned to a Lifestyle Intervention (n = 150) or a Health & Wellness (control) Intervention (n = 150). Multimodal contacts (i.e., in-person, telephone, and mailed materials) will be used to deliver the intervention from late pregnancy (29 weeks gestation) to 12 months postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific cultural and environmental challenges faced by low-income Hispanic women. Assessments will be conducted at enrollment, and at 6-weeks, 6-months, and 12-months postpartum by trained bicultural and bilingual personnel blinded to the intervention arm. Efficacy will be assessed via postpartum weight loss and biomarkers of insulin resistance and cardiovascular risk. Changes in physical activity and diet will be measured via 7-day actigraph data and three unannounced 24-hour dietary recalls at each assessment time period.

Discussion: Hispanic women are the fastest growing minority group in the U.S. and have the highest rates of sedentary behavior and postpartum diabetes after a diagnosis of GDM. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations.

Trial registration: NCT01679210.

Figures

Figure 1
Figure 1
Trial design.

References

    1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27(5):1047–1053. doi: 10.2337/diacare.27.5.1047.
    1. 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. doi: 10.2337/diacare.25.10.1862.
    1. Retnakaran R. Glucose tolerance status in pregnancy: a window to the future risk of diabetes and cardiovascular disease in young women. Curr Diabetes Rev. 2009;5(4):239–244. doi: 10.2174/157339909789804378.
    1. Bellamy L, Casas J, Hingorani A, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009;373(9677):1773–1779. doi: 10.1016/S0140-6736(09)60731-5.
    1. Cheung NW, Byth K. Population health significance of gestational diabetes. Diabetes Care. 2003;26(7):2005–2009. doi: 10.2337/diacare.26.7.2005.
    1. Kjos SL, Peters RK, Xiang A, Henry OA, Montoro M, Buchanan TA. Predicting future diabetes in Latino women with gestational diabetes. Utility of early postpartum glucose tolerance testing. Diabetes. 1995;44(5):586–591. doi: 10.2337/diab.44.5.586.
    1. Buchanan TA, Xiang A, Kjos SL, Lee WP, Trigo E, Nader I, Bergner EA, Palmer JP, Peters RK. Gestational diabetes: antepartum characteristics that predict postpartum glucose intolerance and type 2 diabetes in Latino women. Diabetes. 1998;47(8):1302–1310. doi: 10.2337/diab.47.8.1302.
    1. Retnakaran R, Qi Y, Connelly P, Sermer M, Hanley A, Zinman B. Risk of early progression to Pre-diabetes or diabetes in women with recent gestational dysglycemia but normal glucose tolerance at 3-months postpartum. Clin Endocrinol (Oxf) 2010. Jun 9. [Epub ahead of print]
    1. Ratner RE, Christophi CA, Metzger BE, Dabelea D, Bennett PH, Pi-Sunyer X, Fowler S, Kahn SE. Diabetes Prevention Program Research Group. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab. 2008;93(12):4774–4779. doi: 10.1210/jc.2008-0772.
    1. Hamman R, Wing R, Edelstein S, Lachin J, Bray G, Delahanty L, Hoskin M, Kriska A, Mayer-Davis E, Pi-Sunyer X, Regensteiner J, Venditti B, Wylie-Rosett J. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care. 2006;29(9):2102–2107. doi: 10.2337/dc06-0560.
    1. Kim C. Gestational diabetes: risks, management, and treatment options. Int J Womens Health. 2010;2:339–351.
    1. Lovelady CA, Garner KE, Moreno KL, Williams JP. The effect of weight loss in overweight, lactating women on the growth of their infants. N Engl J Med. 2000;342(7):449–453. doi: 10.1056/NEJM200002173420701.
    1. O’Toole ML, Sawicki MA, Artal R. Structured diet and physical activity prevent postpartum weight retention. J Womens Health (Larchmt) 2003;12(10):991–998. doi: 10.1089/154099903322643910.
    1. Lovelady CA, Nommsen Rivers LA, McCrory MA, Dewey KG. Effects of exercise on plasma lipids and metabolism of lactating women. Med Sci Sports Exerc. 1995;27(1):22–28.
    1. Norris SL, Zhang X, Avenell A, Gregg E, Schmid CH, Lau J. Long-term non-pharmacological weight loss interventions for adults with prediabetes. Cochrane Database Syst Rev. 2005;2:CD005270.
    1. Moore H, Summerbell C, Hooper L, Cruickshank K, Vyas A, Johnstone P, Ashton V, Kopelman P. Dietary advice for treatment of type 2 diabetes mellitus in adults. Cochrane Database Syst Rev. 2004;3:CD004097.
    1. Shaw K, O’Rourke P, Del Mar C, Kenardy J. Psychological interventions for overweight or obesity. Cochrane Database Syst Rev. 2005;2:CD003818.
    1. Stuebe A, Ecker J, Bates DW, Zera C, Bentley-Lewis R, Seely E. Barriers to follow-up for women with a history of gestational diabetes. Am J Perinatol. 2010;27(9):705–710. doi: 10.1055/s-0030-1253102.
    1. U.S. Department of Commerce Economics and Statistics Administration. US Census Bureau. The American Community—Hispanics: 2004. American Community Survey Reports. 2007. pp. 1–22.
    1. Projections of the Population by Sex, Race, and Hispanic Origin for the United States: 2010 to 2050. Washington, DC: US Census Bureau; 2014. .
    1. Giardina E, Laudano M, Hurstak E, Saroff A, Fleck E, Sciacca R, Boden-Albala B, Cassetta J. Physical activity participation among Caribbean Hispanic women living in New York: relation to education, income, and age. J Womens Health. 2009;18(2):187–193. doi: 10.1089/jwh.2008.0946.
    1. Zambrana RE, Logie LA. Latino child health: need for inclusion in the US national discourse. Am J Public Health. 2000;90(12):1827–1833.
    1. Centers for Disease Control and Prevention (CDC) Prevalence of physical activity, including lifestyle activities among adults--United States, 2000-2001. MMWR Morb Mortal Wkly Rep. 2003;52(32):764–769.
    1. Anonymous. Health disparities experienced by Hispanics--United States. Morb Mortal Wkly Rep. 2004;53(40):935–937.
    1. Rosal MC, Borg A, Bodenlos JS, Tellez T, Ockene IS. Awareness of diabetes risk factors and diabetes prevention strategies among a sample of low-income Latinos with no known diagnosis of diabetes. Diabetes Educ. 2011;37(1):47–55. doi: 10.1177/0145721710392247.
    1. Stasenko M, Cheng YW, McLean T, Jelin AC, Rand L, Caughey AB. Postpartum follow-up for women with gestational diabetes mellitus. Am J Perinatol. 2010;27(9):737–742. doi: 10.1055/s-0030-1253557.
    1. Rasmussen KM, Yaktine AL, editor. Committee to Reexamine IOM Pregnancy Weight Guideline. Weight gain during pregnancy: reexamining the guidelines. Washington (DC): National Academies Press (US); 2009.
    1. ACOG Committee Obstetric Practice. ACOG Committee opinion. Number 267, January 2002: Exercise during pregnancy and the postpartum period. Obstet Gynecol. 2002;99(1):171–173. doi: 10.1016/S0029-7844(01)01749-5.
    1. Anonymous. American diabetes association position statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. J Am Diet Assoc. 2002;102(1):109–118. doi: 10.1016/S0002-8223(02)90031-3.
    1. Chasan-Taber L, Fortner RT, Hastings V, Markenson G. Strategies for recruiting Hispanic women into a prospective cohort study of modifiable risk factors for gestational diabetes mellitus. BMC Pregnancy Childbirth. 2009;9:57. doi: 10.1186/1471-2393-9-57.
    1. American Diabetes Association. Diabetes Care. 2004. pp. S88–S90.
    1. Rosal M, Ockene I, Restrepo A, White M, Borg A, Olendzki B, Scavron J, Candib L, Welch G, Reed G. Randomized trial of a literacy-sensitive, culturally tailored diabetes self-management intervention for Low-income Latinos: Latinos en control. Diabetes Care. 2011;34(4):838–844. doi: 10.2337/dc10-1981.
    1. Rosal M, Lemon S, Nguyen OH, Driscoll NE, Ditaranto L. Translation of the diabetes prevention program lifestyle intervention for promoting postpartum weight loss among low-income women. Translational Behavioral Med. 2011;1(4):530–538. doi: 10.1007/s13142-011-0069-4.
    1. Ockene I, Tellez T, Rosal M, Reed G, Mordes J, Merriam P, Olendzki B, Handelman G, Nicolosi R, Ma Y. Outcomes of a Latino community-based intervention for the prevention of diabetes: the Lawrence Latino diabetes prevention project. Am J Public Health. 2012;102(2):336–342. doi: 10.2105/AJPH.2011.300357.
    1. Rosal MC, Olendzki B, Reed GW, Gumieniak O, Scavron J, Ockene I. Diabetes self-management among low-income Spanish-speaking patients: a pilot study. Ann Behav Med. 2005;29(3):225–235. doi: 10.1207/s15324796abm2903_9.
    1. Chasan-Taber L, Marcus B, Stanek E, Ciccolo J, Marquez D, Solomon C, Markenson G. A randomized controlled trial of prenatal physical activity to prevent gestational diabetes: design and methods. J Womens Health. 2009;18(6):851–859. doi: 10.1089/jwh.2008.1006.
    1. Marcus BH, Lewis BA, Williams DM, Dunsiger S, Jakicic JM, Whiteley JA, Albrecht AE, Napolitano MA, Bock BC, Tate DF, Sciamanna CN, Parisi AF. A comparison of Internet and print-based physical activity interventions. Arch Intern Med. 2007;167(9):944–949. doi: 10.1001/archinte.167.9.944.
    1. Marcus BH, Lewis BA, Williams DM, Whiteley JA, Albrecht AE, Jakicic JM, Parisi AF, Hogan JW, Napolitano MA, Bock BC. Step into motion: a randomized trial examining the relative efficacy of internet vs. Print-based physical activity interventions. Contemp Clin Trials. 2007;28(6):737–747. doi: 10.1016/j.cct.2007.04.003.
    1. Marcus BH, Napolitano MA, King AC, Lewis BA, Whiteley JA, Albrecht A, Parisi A, Bock B, Pinto B, Sciamanna C, Jakicic J, Papandonatos GD. Telephone versus print delivery of an individualized motivationally tailored physical activity intervention: Project STRIDE. Health Psychol. 2007;26(4):401–409.
    1. Bandura A. Self-Efficacy: The Exercise of Control. New York: Freeman; 1997.
    1. Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983;51(3):390–395.
    1. Neighbors C, Marquez D, Marcus B. Leisure-time physical activity disparities among Hispanic subgroups in the United States. Am J Public Health. 2008;98(8):1460–1464. doi: 10.2105/AJPH.2006.096982.
    1. Marquez D, Bustamante E, Bock B, Markenson G, Tovar A, Chasan-Taber L. Perspectives of Latina and non-Latina white women on barriers and facilitators to exercise in pregnancy. Women Health. 2009;49(6):505–521.
    1. Marcus BH, Selby VC, Niaura RS, Rossi JS. Self-efficacy and the stages of exercise behavior change. Res Q Exerc Sport. 1992;63(1):60–66. doi: 10.1080/02701367.1992.10607557.
    1. Marcus BH, Rossi JS, Selby VC, Niaura RS, Abrams DB. The stages and processes of exercise adoption and maintenance in a worksite sample. Health Psychol. 1992;11(6):386–395.
    1. Marcus BH, Bock BC, Pinto BM, Forsyth LH, Roberts MB, Traficante RM. Efficacy of an individualized, motivationally-tailored physical activity intervention. Ann Behav Med. 1998;20(3):174–180. doi: 10.1007/BF02884958.
    1. Marcus BH, Emmons KM, Simkin-Silverman LR, Linnan LA, Taylor ER, Bock BC, Roberts MB, Rossi JS, Abrams BD. Evaluation of motivationally tailored vs. standard self-help physical activity interventions at the workplace. Am J Health Promot. 1998;12(4):246–253. doi: 10.4278/0890-1171-12.4.246.
    1. Marcus B, Lewis B, King T, Albrecht A, Hogan J, Bock B, Parisi A, Abrams D. Rationale, design, and baseline data for commit to quit II: an evaluation of the efficacy of moderate-intensity physical activity as an aid to smoking cessation in women. Prev Med. 2003;36(4):479–492. doi: 10.1016/S0091-7435(02)00051-8.
    1. Metzger BE. Summary and recommendations of the Fifth International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. 2007;30(Suppl 2):S251.
    1. van Hees V, Renstrom F, Wright A, Gradmark A, Catt M, Chen K, Lof M, Bluck L, Pomeroy J, Wareham N, Ekelund U, Brage S, Franks P. Estimation of daily energy expenditure in pregnant and non-pregnant women using a wrist-worn tri-axial accelerometer. PLoS One. 2011;6(7):e22922. doi: 10.1371/journal.pone.0022922.
    1. St-Onge M, Mignault D, Allison D, Rabasa-Lhoret R. Evaluation of a portable device to measure daily energy expenditure in free-living adults. Am J Clin Nutr. 2007;85(3):742–749.
    1. Kozey-Keadle S, Libertine A, Lyden K, Staudenmayer J, Freedson P. Validation of wearable monitors for assessing sedentary behavior. Med Sci Sports Exerc. 2011;43(8):1561–1567. doi: 10.1249/MSS.0b013e31820ce174.
    1. Ridgers N, Salmon J, Ridley K, O’Connell E, Arundell L, Timperio A. Agreement between activPAL and ActiGraph for assessing children's sedentary time. Int J Behav Nutr Phys Act. 2012;9:15. doi: 10.1186/1479-5868-9-15.
    1. 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(10):1750–1756. doi: 10.1249/01.MSS.0000142303.49306.0D. quiz 1757-60.
    1. Tropp LR, Erkut S, Coll CG, Alarcon O, Vazquez Garcia HA. Psychological acculturation: development of a new measure for Puerto Ricans on the U.S. Mainland. Educ Psychol Meas. 1999;59(2):351–367. doi: 10.1177/00131649921969794.
    1. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213. doi: 10.1016/0165-1781(89)90047-4.
    1. 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. doi: 10.1192/bjp.150.6.782.
    1. Jadresic E, Araya R, Jara C. Validation of the Edinburgh postnatal depression scale (EPDS) in Chilean postpartum women. J Psychosom Obstet Gynaecol. 1995;16(4):187–191. doi: 10.3109/01674829509024468.
    1. Lakshman R, Landsbaugh J, Schiff A, Hardeman W, Ong K, Griffin S. Development of a questionnaire to assess maternal attitudes towards infant growth and milk feeding practices. Int J Behav Nutr Phys Act. 2011;8(1):35. doi: 10.1186/1479-5868-8-35.
    1. Stanek EJ3. Choosing a pretest-posttest analysis. The American Statistician. 1988;42(3):178–183.
    1. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2. Hillsdale, NJ: Erlbaum; 1988.
    1. Kim C. Managing women with gestational diabetes mellitus in the postnatal period. Diabetes Obes Metab. 2010;12(1):20–25. doi: 10.1111/j.1463-1326.2009.01147.x.
    1. Chasan Taber L. Physical activity and dietary behaviors associated with weight gain and impaired glucose tolerance among pregnant Latinas. Adv Nutr. 2012;3(1):108–118. doi: 10.3945/an.111.001214.
    1. Frayne SM, Burns RB, Hardt EJ, Rosen AK, Moskowitz MA. The exclusion of non-English-speaking persons from research. J Gen Intern Med. 1996;11(1):39–43. doi: 10.1007/BF02603484.
    1. Durant R, Davis R, St George DMM, Williams I, Blumenthal C, Corbie-Smith G. Participation in research studies: factors associated with failing to meet minority recruitment goals. Ann Epidemiol. 2007;17(8):634–642. doi: 10.1016/j.annepidem.2007.02.003.

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