Study of a Postpartum Diabetes Prevention Program for Hispanic Women

• ClinicalTrials.gov Identifier: NCT01679210
• Recruitment Status: Completed
• First Posted: September 5, 2012
• Last Update Posted: March 10, 2020
• Sponsor: University of Massachusetts, Amherst
• 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

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	Phase
Diabetes	Behavioral: Lifestyle Intervention	Not Applicable

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 the Pregnancy Physical Activity Questionnaire (PPAQ), 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)
• Actual Enrollment: 263 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
• Actual Primary Completion Date: June 2018
• Actual Study Completion Date: June 2018

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; HW served as the comparison group and received the same number of in-person sessions, telephone calls, and mailings at the same time points as LI. Content was limited to general information available to the public from the ACOG and the American Academy of Pediatrics and did not mention exercise behavior change.

Outcome Measures

Primary Outcome Measures :

1. Fasting Glucose (FG) [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
   Fasting Glucose (FG) will be measured enzymatically on the Roche P Modular system using Roche Diagnostics reagents (Indianapolis, IN)(mg/dL).
2. Fasting Insulin (FI) [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
   Fasting Insulin (FI) will be measured by an electrochemiluminescence immunoassay on the Roche E Modular system in uU/mL.
3. Hemoglobin A1c (HbA1c) [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
   The Hemoglobin A1c (HbA1c) determination on the Roche P Modular system will be based on turbidimetric immunoinhibition using packed red cells.
4. Leptin [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
   Leptin will be measured by an ultra-sensitive ELISA assay, an enzymatically amplified "two-step" sandwich-type immunoassay (R&D Systems, Minneapolis, MN) (pg/mL).
5. Total Adiponectin [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
   Total Adiponectin (Multimeric) will be measured using an ELISA method from ALPCO Diagnostics Inc. (Salem, NH).
6. Lipoprotein Profile [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
   Lipoprotein Profile: will be simultaneously performed on the Roche P Modular system. Total Cholesterol will be measured enzymatically (mg/dL). Triglycerides will be measured enzymatically with correction for endogenous glycerol (mg/dL). The concentration of High Density Lipoprotein Cholesterol will be determined using a direct enzymatic colorimetric assay (mg/dL). Low Density Lipoprotein Cholesterol will be determined by a homogenous direct method (mg/dL).
7. High Sensitivity C-Reactive Protein [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
   The concentration of High Sensitivity C-Reactive Protein (hsCRP) will be determined using an immunoturbidimetric assay on the Roche P Modular system using reagents and calibrators from DiaSorin (Stillwater, MN) (mg/L).
8. TNF [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
   TNF-receptor II is measured by an ELISA assay from R&D Systems (pg/mL).
9. Albumin-to-creatinine ratio (ACR) [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
   Albumin-to-creatinine ratio (ACR): Albumin will be measured by a colorimetric assay, an automated dye-binding method using the Roche P Modular system and Roche Diagnostics reagents (Indianapolis, IN) (g/dL). Creatinine will be measured by an enzymatic method using the Roche P Modular system and Roche Diagnostics reagents (Indianapolis, IN) (mg/dL).
10. Fetuin-A [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
    Fetuin-A will be measured by an enzyme immunoassay (EIA) (BioVendor - Candler, NC) (ng/mL).
11. Postpartum weight loss [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
    Postpartum Weight Loss will be measured as the difference between weight at 6 or 12 mos postpartum and weight at delivery. Weight will be measured on a digital scale.
12. Physical activity [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
    Total activity according to intensity will be measured via the Pregnancy Physical Activity Questionnaire (PPAQ) and hip worn accelerometer. (MET-hrs/week).
13. Dietary Intake [ Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum ]
    Total calories, along with the other nutrients, will be measured via three 24-hr dietary recalls.

Eligibility Criteria

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

Locations

United States, Massachusetts

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

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

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gubrium A, Leckenby D, Harvey MW, Marcus BH, Rosal MC, Chasan-Taber L. Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment. BMC Health Serv Res. 2019 Jun 6;19(1):357. doi: 10.1186/s12913-019-4207-x.

• Responsible Party: Lisa Chasan-Taber, Associate Professor of Epidemiology, University of Massachusetts, Amherst
• ClinicalTrials.gov Identifier: NCT01679210
• Other Study ID Numbers: NIH 2R01DK064902-06A1
• First Posted: September 5, 2012
• Last Update Posted: March 10, 2020
• Last Verified: March 2020

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