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

August 7, 2012
December 11, 2013
January 2013
January 2016   (final data collection date for primary outcome measure)
  • 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.
  • Postpartum Type 2 Diabetes [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • Postpartum Type 2 Diabetes [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
  • Postpartum Type 2 Diabetes [ Time Frame: 12 months postpartum ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01679210 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of a Postpartum Diabetes Prevention Program for Hispanic Women
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes
Behavioral: Lifestyle Intervention
Stage-matched physical activity and diet intervention materials and health education.
  • Experimental: Lifestyle Intervention
    Stage-matched physical activity and diet intervention materials and health education.
    Intervention: Behavioral: Lifestyle Intervention
  • No Intervention: Health and Wellness
    Standard of care group.
Chasan-Taber L, Marcus BH, Rosal MC, Tucker KL, Hartman SJ, Pekow P, Braun B, Moore Simas TA, Solomon CG, Manson JE, Markenson G. Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial - study protocol. BMC Pregnancy Childbirth. 2014 Mar 10;14:100. doi: 10.1186/1471-2393-14-100.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
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
 
NCT01679210
NIH 2R01DK064902-06A1
Yes
Lisa Chasan-Taber, University of Massachusetts, Amherst
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
University of Massachusetts, Amherst
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP