title: Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial - study protocol.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT01679210.
authors.affiliation: Division of Biostatistics & Epidemiology, Department of Public Health, School of Public Health & Health Sciences, University of Massachusetts, 405 Arnold House, 715 North Pleasant Street, Amherst, MA 01003-9304, USA. LCT@schoolph.umass.edu.
authors.forename: Lisa
authors.initials: L
authors.lastname: Chasan-Taber
authors.forename: Bess H
authors.initials: BH
authors.lastname: Marcus
authors.forename: Milagros C
authors.initials: MC
authors.lastname: Rosal
authors.forename: Katherine L
authors.initials: KL
authors.lastname: Tucker
authors.forename: Sheri J
authors.initials: SJ
authors.lastname: Hartman
authors.forename: Penelope
authors.initials: P
authors.lastname: Pekow
authors.forename: Barry
authors.initials: B
authors.lastname: Braun
authors.forename: Tiffany A
authors.initials: TA
authors.lastname: Moore Simas
authors.forename: Caren G
authors.initials: CG
authors.lastname: Solomon
authors.forename: Joann E
authors.initials: JE
authors.lastname: Manson
authors.forename: Glenn
authors.initials: G
authors.lastname: Markenson
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D016640:Diabetes, Gestational / Q000097:blood / Q000208:ethnology / Q000517:prevention & control*; D005247:Feeding Behavior; D005260:Female; D018149:Glucose Intolerance / Q000097:blood / Q000208:ethnology / Q000517:prevention & control*; D006630:Hispanic or Latino; D006801:Humans; D015994:Incidence; D007333:Insulin Resistance; D008019:Life Style; D011181:Postnatal Care / Q000379:methods*; D049590:Postpartum Period; D011247:Pregnancy; D012307:Risk Factors; D014481:United States / Q000453:epidemiology
chemical_list: D001786:Blood Glucose