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Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial - study protocol
Open Access Articles
  • Lisa Chasan-Taber, University of Massachusetts, Amherst
  • Bess H. Marcus, University of California - San Diego
  • Milagros C. Rosal, University of Massachusetts Medical School
  • Katherine L. Tucker, University of Massachusetts Medical School Worcester
  • Sheri J. Hartman, University of California - San Diego
  • Penelope S. Pekow, University of Massachusetts - Amherst
  • Barry Braun, University of Massachusetts Amherst
  • Tiffany A. Moore Simas, University of Massachusetts Medical School
  • Caren G. Solomon, Harvard Medical School
  • Joann E. Manson, Harvard Medical School
  • Glenn Markenson, Baystate Medical Center
UMMS Affiliation
Department of Medicine, Division of Preventive and Behavioral Medicine; Department of Obstetrics & Gynecology
Publication Date
Document Type
Adult; Blood Glucose; Diabetes, Gestational; Female; *Food Habits; Glucose Intolerance; *Hispanic Americans; Humans; Incidence; *Insulin Resistance; Life Style; Postnatal Care; *Postpartum Period; Pregnancy; Risk Factors; United States
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 and 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.
DOI of Published Version
BMC Pregnancy Childbirth. 2014 Mar 10;14:100. doi: 10.1186/1471-2393-14-100. Link to article on publisher's site
Related Resources
Link to Article in PubMed
PubMed ID
Creative Commons License
Creative Commons Attribution 4.0
Citation Information
Lisa Chasan-Taber, Bess H. Marcus, Milagros C. Rosal, Katherine L. Tucker, et al.. "Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial - study protocol" Vol. 14 (2014) ISSN: 1471-2393 (Linking)
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