Clinical trial NCT01679210: Study of a Postpartum Diabetes Prevention Program for Hispanic Women
Official title: Estudio PARTO: Proyecto pAra Reducir Diabetes Tipo dOs / Project Aiming to Reduce Type twO Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: Northeastern University
name: Baystate Medical Center
name: University of Massachusetts, Worcester
First posted: 2012-09-05
Enrollment: 263
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postpartum weight change
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Percent of participants meeting postpartum weight goals
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Fasting Glucose (FG)
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Fasting Insulin (FI)
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Hemoglobin A1c (HbA1c)
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Leptin
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Total Adiponectin
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Lipoprotein Profile
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: High Sensitivity C-Reactive Protein
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: TNF
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Albumin-to-creatinine ratio (ACR)
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Fetuin-A
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Physical activity
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
measure: Dietary Intake
timeFrame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Amherst
name: Lisa Chasan-Taber, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wilkie G, Leung K, Moore Simas TA, Tucker KL, Chasan-Taber L. The Association Between Acculturation and Diet and Physical Activity Among Pregnant Hispanic Women with Abnormal Glucose Tolerance. J Womens Health (Larchmt). 2022 Dec;31(12):1791-1799. doi: 10.1089/jwh.2022.0017. Epub 2022 Aug 30.
citation: Moore Simas TA, Leung K, Nuss E, Marieni M, Marcus B, Rosal MC, Chasan-Taber L. Factors Associated with Risk of Perinatal Depressive Symptoms Among Puerto Rican Women with Hyperglycemia. Matern Child Health J. 2022 Aug;26(8):1741-1751. doi: 10.1007/s10995-022-03429-y. Epub 2022 Apr 6.
citation: Hawkins M, Marcus B, Pekow P, Rosal MC, Tucker KL, Spencer RMC, Chasan-Taber L. The Impact of a Randomized Controlled Trial of a Lifestyle Intervention on Sleep Among Latina Postpartum Women. Ann Behav Med. 2021 Aug 23;55(9):892-903. doi: 10.1093/abm/kaaa118.
citation: Gubrium A, Leckenby D, Harvey MW, Marcus BH, Rosal MC, Chasan-Taber L. Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment. BMC Health Serv Res. 2019 Jun 6;19(1):357. doi: 10.1186/s12913-019-4207-x.