Study of a Postpartum Diabetes Prevention Program for Hispanic Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Estudio PARTO: Proyecto pAra Reducir Diabetes Tipo dOs / Project Aiming to Reduce Type twO Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Intervention<br>Stage-matched physical activity and diet intervention materials and health education. | Behavioral: Lifestyle Intervention<br>* Stage-matched physical activity and diet intervention materials and health education.<br>|
| No Intervention: Health and Wellness<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum weight change | 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Percent of participants meeting postpartum weight goals | 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Fasting Glucose (FG) | Fasting Glucose (FG) will be measured enzymatically on the Roche P Modular system using Roche Diagnostics reagents (Indianapolis, IN)(mg/dL). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Fasting Insulin (FI) | Fasting Insulin (FI) will be measured by an electrochemiluminescence immunoassay on the Roche E Modular system in uU/mL. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Hemoglobin A1c (HbA1c) | The Hemoglobin A1c (HbA1c) determination on the Roche P Modular system will be based on turbidimetric immunoinhibition using packed red cells. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Leptin | 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). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Total Adiponectin | Total Adiponectin (Multimeric) will be measured using an ELISA method from ALPCO Diagnostics Inc. (Salem, NH). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Lipoprotein Profile | 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). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| High Sensitivity C-Reactive Protein | 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). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| TNF | TNF-receptor II is measured by an ELISA assay from R&D Systems (pg/mL). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Albumin-to-creatinine ratio (ACR) | 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). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Fetuin-A | Fetuin-A will be measured by an enzyme immunoassay (EIA) (BioVendor - Candler, NC) (ng/mL). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Physical activity | Total activity according to intensity will be measured via the Pregnancy Physical Activity Questionnaire (PPAQ) and hip worn accelerometer. (MET-hrs/week). | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | 
| Dietary Intake | Total calories, along with the other nutrients, will be measured via three 24-hr dietary recalls. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |