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Completed

NCT Number: NCT01679210

Study of a Postpartum Diabetes Prevention Program for Hispanic Women

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

Stage-matched physical activity and diet intervention materials and health education.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Amherst

Other

Collaborators

  • Baystate Medical Center
  • Northeastern University
  • University of California, San Diego
  • University of Massachusetts, Worcester

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2012
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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