Study of a Postpartum Diabetes Prevention Program for Hispanic Women
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ClinicalTrials.gov Identifier: NCT01679210 |
Recruitment Status :
Completed
First Posted : September 5, 2012
Last Update Posted : April 29, 2020
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Condition or disease | Intervention/treatment | Phase |
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Diabetes | Behavioral: Lifestyle Intervention | Not Applicable |
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 |
Arm | Intervention/treatment |
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Experimental: Lifestyle Intervention
Stage-matched physical activity and diet intervention materials and health education.
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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.
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- 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.
- 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.
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679210
United States, Massachusetts | |
Baystate Medical Center | |
Springfield, Massachusetts, United States, 01199 |
Principal Investigator: | Lisa Chasan-Taber, ScD | University of Massachusetts, Amherst |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
Last Update Posted: | April 29, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |