Study of a Postpartum Diabetes Prevention Program for Hispanic Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Massachusetts, Amherst
Sponsor:
Collaborators:
University of California, San Diego
Northeastern University
Baystate Medical Center
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Lisa Chasan-Taber, University of Massachusetts, Amherst
ClinicalTrials.gov Identifier:
NCT01679210
First received: August 7, 2012
Last updated: December 11, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Amherst:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679210

Contacts
Contact: Lisa Chasan-Taber, ScD 413-545-1664 lct@schoolph.umass.edu
Contact: Megan W Harvey, MS 413-545-6732 meward@schoolph.umass.edu

Locations
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         
Sponsors and Collaborators
University of Massachusetts, Amherst
University of California, San Diego
Northeastern University
Baystate Medical Center
University of Massachusetts, Worcester
Investigators
Principal Investigator: Lisa Chasan-Taber, ScD University of Massachusetts, Amherst
  More Information

No publications provided by University of Massachusetts, Amherst

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: December 11, 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 September 30, 2014