Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial – study protocol

BMC Pregnancy and Childbirth

Glenn Markenson¹  JoAnn E Manson⁶  Caren G Solomon⁶  Tiffany A Moore Simas³  Barry Braun²  Penelope Pekow⁵  Sheri J Hartman⁷  Katherine L Tucker⁴  Milagros C Rosal⁴  Bess H Marcus⁷  Lisa Chasan-Taber⁵ 

[1] Baystate Medical Center, Springfield MA, USA;Department of Kinesiology, School of Public Health & Health Sciences, University of Massachusetts, Amherst MA, USA;Departments of Obstetrics & Gynecology and Pediatrics, University of Massachusetts Medical School, Worcester MA, USA;Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, Worcester MA, USA;Division of Biostatistics & Epidemiology, Department of Public Health, School of Public Health & Health Sciences, University of Massachusetts, 405 Arnold House, 715 North Pleasant Street, Amherst, MA 01003-9304, USA;Brigham and Women’s Hospital and Harvard Medical School, Boston MA, USA;Department of Family and Preventive Medicine, School of Medicine, University of California San Diego, La Jolla CA, USA

关键词: Transtheoretical model;    Gestational diabetes mellitus;    Pregnancy;    Postpartum;    Physical activity;    Latina;    Diet;    Prevention;    Healthy eating;    Randomised controlled trial;    Lifestyle intervention;   

Others  :  1127508
DOI  :  10.1186/1471-2393-14-100

 received in 2014-02-11, accepted in 2014-02-26,  发布年份 2014

【 摘 要 】

Background

Diabetes and obesity have reached epidemic proportions in the U.S. with rates consistently higher among Hispanics as compared to non-Hispanic whites. Among Hispanic women diagnosed with gestational diabetes mellitus (GDM), 50% will go on to develop type 2 diabetes within 5 years of the index pregnancy. Although randomised controlled trials among adults with impaired glucose tolerance have shown that diet and physical activity reduce the risk of type 2 diabetes, such programs have not been tested in high-risk postpartum women. The overall goal of this randomised 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.

Methods/Design

Hispanic pregnant women who screen positive for GDM will be recruited and randomly assigned to a Lifestyle Intervention (n = 150) or a Health & Wellness (control) Intervention (n = 150). Multimodal contacts (i.e., in-person, telephone, and mailed materials) will be used to deliver the intervention from late pregnancy (29 weeks gestation) to 12 months postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss; American Congress 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 cultural and environmental challenges faced by low-income Hispanic women. Assessments will be conducted at enrollment, and at 6-weeks, 6-months, and 12-months postpartum by trained bicultural and bilingual personnel blinded to the intervention arm. Efficacy will be assessed via postpartum weight loss and biomarkers of insulin resistance and cardiovascular risk. Changes in physical activity and diet will be measured via 7-day actigraph data and three unannounced 24-hour dietary recalls at each assessment time period.

Discussion

Hispanic women are the fastest growing minority group in the U.S. and have the highest rates of sedentary behavior and postpartum diabetes after a diagnosis of GDM. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations.

Trial registration

NCT01679210

【 授权许可】

   
2014 Chasan-Taber et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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