Study of a Postpartum Diabetes Prevention Program for Hispanic Women
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The overall goal of this randomized 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.
    

Detailed description: 
      Specific aims are to evaluate the impact of the intervention on 1) postpartum weight loss, 2)
      biomarkers associated with insulin resistance (i.e., glucose, insulin, HbA1c, leptin, TNF-α,
      HOMA, AUCgluc, adiponectin), 3) other cardiovascular risk factors (i.e., blood lipids, blood
      pressure, CRP, fetuin-A, albumin-to-creatinine ratio), and 4) the adoption and maintenance of
      postpartum behaviors associated with weight loss and prevention of diabetes risk (i.e.,
      physical activity, diet). Eligible Hispanic women will be recruited after routine GDM
      screening and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health
      and Wellness (control) intervention (n=150). The intervention will be based on our
      efficacious exercise and dietary interventions for Hispanics (R01NR011295; WIC Common
      Pathways). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based
      materials) will be used to deliver the intervention from randomization (29 wks gestation) to
      12 months postpartum. Targets of the intervention are to achieve Institute of Medicine
      Guidelines for postpartum weight loss; American College 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 social, cultural, economic, and physical environmental challenges faced by
      underserved Hispanic women. Measures of adherence will include the Pregnancy Physical
      Activity Questionnaire (PPAQ), accelerometers, and dietary recalls. The project is a Renewal
      Application of R01 DK064902, a study of lifestyle risk factors for GDM in Hispanic women. The
      proposed project builds upon the expertise of the investigative team in conducting randomized
      controlled trials of lifestyle interventions among Hispanic pregnant women (R01 DK074876;
      S3948 ASPH/CDC) and controlled trials of lifestyle interventions among low-income Hispanics
      with type 2 diabetes and pre-diabetes (R18 DK0658850; R18DK067549) and can readily be
      translated into clinical practice in underserved and minority populations.
    

Intervention name(s): Lifestyle Intervention
Intervention type(s): Behavioral
Intervention description(s): Stage-matched physical activity and diet intervention materials and health education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment