Study of a Postpartum Diabetes Prevention Program for Hispanic Women



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 45
Updated:10/13/2018
Start Date:January 2013
End Date:June 2018

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Estudio PARTO: Proyecto pAra Reducir Diabetes Tipo dOs / Project Aiming to Reduce Type twO Diabetes

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.

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 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.

Inclusion Criteria:

- Hispanic women with one or more glucose values during the diagnostic test meeting or
exceeding the thresholds defined according to the American Diabetes Association

Exclusion Criteria:

- history of type 1 or type 2 diabetes, heart disease, or chronic renal disease

- contraindications to postpartum participation in moderate physical activity or a
low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis)

- inability to read English or Spanish at a 6th grade level

- <18 or >45 yrs of age

- women carrying multiples
We found this trial at
2
sites
Worcester, Massachusetts 01655
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759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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