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Study of a Postpartum Diabetes Prevention Program for Hispanic Women

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ClinicalTrials.gov Identifier: NCT01679210
Recruitment Status : Recruiting
First Posted : September 5, 2012
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Diabetes Behavioral: Lifestyle Intervention

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Estudio PARTO: Proyecto pAra Reducir Diabetes Tipo dOs / Project Aiming to Reduce Type twO Diabetes
Study Start Date : January 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Postpartum Type 2 Diabetes [ Time Frame: 6 weeks postpartum ]
    Type 2 Diabetes will be measured via a 2 hour oral glucose tolerance test.

  2. Postpartum Type 2 Diabetes [ Time Frame: 6 months postpartum ]
    Type 2 Diabetes will be measured via a 2 hour oral glucose tolerance test.

  3. Postpartum Type 2 Diabetes [ Time Frame: 12 months postpartum ]
    Type 2 Diabetes will be measured via a 2 hour oral glucose tolerance test.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679210

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

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
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases