Estudio PARTO: Proyecto pAra Reducir Diabetes Tipo dOs / Project Aiming to Reduce Type twO Diabetes
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- University of Massachusetts, Amherst
- Enrollment
- 263
- Locations
- 1
- Primary Endpoint
- Percent of participants meeting postpartum weight goals
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Lisa Chasan-Taber
Associate Professor of Epidemiology
University of Massachusetts, Amherst
Eligibility 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
Outcomes
Primary Outcomes
Percent of participants meeting postpartum weight goals
Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Postpartum weight goals will be defined as weight change to prepregnancy weight if prepregnancy BMI was normal, or a 5% change towards prepregnancy weight if prepregnancy BMI was overweight/obese. Weight will be measured on a digital scale.
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).
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).
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).
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).
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.
Postpartum weight change
Time Frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Postpartum weight change 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.
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).
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.
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.
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).
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).
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).
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).