Study of a Postpartum Diabetes Prevention Program for Hispanic Women

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679210
• Other study ID #: NIH 2R01DK064902-06A1
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: June 2018

Study information

• Verified date: April 2020
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Behavioral:
• Lifestyle Intervention
Stage-matched physical activity and diet intervention materials and health education.

Locations

Country	Name	City	State
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst	Baystate Medical Center, Northeastern University, University of California, San Diego, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chasan-Taber L, Marcus BH, Rosal MC, Tucker KL, Hartman SJ, Pekow P, Braun B, Moore Simas TA, Solomon CG, Manson JE, Markenson G. Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial - study protocol. BMC Pregnancy Childbirth. 2014 Mar 10;14:100. doi: 10.1186/1471-2393-14-100. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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