Study of a Postpartum Diabetes Prevention Program for Hispanic Women
- Conditions
- Diabetes
- Interventions
- Behavioral: Lifestyle Intervention
- Registration Number
- NCT01679210
- Lead Sponsor
- University of Massachusetts, Amherst
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 263
- Hispanic women with one or more glucose values during the diagnostic test meeting or exceeding the thresholds defined according to the American Diabetes Association
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lifestyle Intervention Lifestyle Intervention Stage-matched physical activity and diet intervention materials and health education.
- Primary Outcome Measures
Name Time Method Percent of participants meeting postpartum weight goals 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 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 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 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) 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 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 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) 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) 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) 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 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 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 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 6 weeks postpartum, 6 months postpartum, 12 months postpartum Fetuin-A will be measured by an enzyme immunoassay (EIA) (BioVendor - Candler, NC) (ng/mL).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States