Study of a Postpartum Diabetes Prevention Program for Hispanic Women
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes |
Behavioral: Lifestyle Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Estudio PARTO: Proyecto pAra Reducir Diabetes Tipo dOs / Project Aiming to Reduce Type twO Diabetes |
- Postpartum Type 2 Diabetes [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]Type 2 Diabetes will be measured via a 2 hour oral glucose tolerance test.
- Postpartum Type 2 Diabetes [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]Type 2 Diabetes will be measured via a 2 hour oral glucose tolerance test.
- Postpartum Type 2 Diabetes [ Time Frame: 12 months postpartum ] [ Designated as safety issue: No ]Type 2 Diabetes will be measured via a 2 hour oral glucose tolerance test.
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lifestyle Intervention
Stage-matched physical activity and diet intervention materials and health education.
|
Behavioral: Lifestyle Intervention
Stage-matched physical activity and diet intervention materials and health education.
|
|
No Intervention: Health and Wellness
Standard of care group.
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Lisa Chasan-Taber, ScD | 413-545-1664 | lct@schoolph.umass.edu |
| Contact: Megan W Harvey, MS | 413-545-6732 | meward@schoolph.umass.edu |
| United States, Massachusetts | |
| Baystate Medical Center | Recruiting |
| Springfield, Massachusetts, United States, 01199 | |
| Contact: Glenn Markenson, MD Glenn.Markenson@baystatehealth.org | |
| Principal Investigator: Glenn Markenson, MD | |
| Univeristy of Massachesetts Medical School | Recruiting |
| Worcestor, Massachusetts, United States, 01655 | |
| Contact: Tiffany Moore Simas, MD, MPH, MEd TiffanyA.MooreSimas@UMassMemorial.org | |
| Principal Investigator: Tiffancy Moore Simas, MD, MPH, MEd | |
| Principal Investigator: | Lisa Chasan-Taber, ScD | University of Massachusetts, Amherst |
More Information
No publications provided
| Responsible Party: | Lisa Chasan-Taber, Associate Professor of Epidemiology, University of Massachusetts, Amherst |
| ClinicalTrials.gov Identifier: | NCT01679210 History of Changes |
| Other Study ID Numbers: | NIH 2R01DK064902-06A1 |
| Study First Received: | August 7, 2012 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013