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

ABSTRACT: 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.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.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.NCT01679210.

SUBMITTER: Chasan-Taber L

PROVIDER: S-EPMC3975296 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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

Chasan-Taber Lisa L Marcus Bess H BH Rosal Milagros C MC Tucker Katherine L KL Hartman Sheri J SJ Pekow Penelope P Braun Barry B Moore Simas Tiffany A TA Solomon Caren G CG Manson Joann E JE Markenson Glenn G

BMC pregnancy and childbirth 20140310

<h4>Background</h4>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 h ...[more]

PMID: 24606590

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Project description:Little is known about the relationships between pregnancy cravings, maternal diet, and development of abnormal glucose tolerance.We examined relationships of pregnancy cravings with dietary intake and risk of developing isolated hyperglycemia (IH), impaired glucose tolerance (IGT), or gestational diabetes (GDM) later in pregnancy.Among 2,022 mothers in Project Viva, a prospective birth cohort recruited from medical practices in eastern Massachusetts between 1999 and 2002, we assessed type of pregnancy craving based on self-report at mean gestation of 10.9 weeks.The outcomes were cross-sectional dietary intake from a food frequency questionnaire and incident IH, IGT, or GDM determined by glucose tolerance screening at 26 to 28 weeks.We used linear regression to analyze the cross-sectional relationships between pregnancy cravings and dietary intake and multinomial logistic regression to analyze the prospective relationships among pregnancy cravings and development of IH, IGT, or GDM.During the first trimester, 443 (22%) women craved sweets, 225 (11%) craved salty foods, 261 (13%) craved savory foods, and 100 (4.9%) craved starchy foods. Sweet cravings were associated with increased intake of sucrose (1.9 g/day; 95% CI 0.1 to 3.7), total fat (1.5 g/day; 95% CI 0.1 to 2.9), and saturated fat (0.8 g/day; 95% CI 0.2 to 1.4); salty cravings were associated with increased fiber (0.7 servings/day; 95% CI -0.1 to 1.6); savory cravings were associated with increased n-3 fatty acids (0.10 g/day; 95% CI 0.02 to 0.17); and starchy cravings were associated with increased carbohydrates (8.0 g/day; 95% CI 0.3 to 15.7) and decreased total fat (-2.6 g/day; 95% CI -5.2 to -0.1). Salty cravings were associated with lower risk of GDM (adjusted odds ratio 0.34, 95% CI 0.12-0.97).New cravings in the first trimester of pregnancy were associated with dietary intake. Craving salty foods may predict reduced risk of developing GDM, whereas craving sweet food does not appear to alter one's risk.

Project description:Aims/hypothesisChronic sub-acute inflammation contributes to the pathogenesis of type 2 diabetes mellitus and cardiovascular disease. High doses of salicylate reduce inflammation, glucose and triacylglycerols, and may improve insulin sensitivity, suggesting therapeutic potential in impaired fasting glucose and/or impaired glucose tolerance. This trial aimed to evaluate the effect of salsalate vs placebo on insulin resistance and glycaemia in impaired fasting glucose and/or impaired glucose tolerance.MethodsWe conducted a 12 week, two-centre, randomised, placebo-controlled study to evaluate the effect of salsalate (up to 4 g/day) vs placebo on systemic glucose disposal. Secondary objectives included treatment effects on glycaemia, inflammation and cardiovascular risk factors. Seventy-eight participants with impaired fasting glucose and/or impaired glucose tolerance from two VA healthcare systems were enrolled. Randomisation assignment was provided by the coordinating center directly to site pharmacists, and participants and research staff were blinded to treatment assignment.ResultsSeventy-one individuals were randomised to placebo (n = 36) or salsalate (n = 35). Glucose disposal did not change in either group (salsalate 1% [95% CI -39%, 56%]; placebo 6% [95% CI -20%, 61%], p = 0.3 for placebo vs salsalate). Fasting glucose was reduced by 6% during the study by salsalate (p = 0.006) but did not change with placebo. Declines in glucose were accompanied by declines in fasting C-peptide with salsalate. Insulin clearance was reduced with salsalate. In the salsalate group, triacylglycerol levels were lower by 25% (p = 0.01) and adiponectin increased by 53% (p = 0.02) at the end of the study. Blood pressure, endothelial function and other inflammation markers did not differ between groups. Adipose tissue nuclear factor κB (NF-κB) activity declined in the salsalate group compared with placebo (-16% vs 42%, p = 0.005), but was not correlated with metabolic improvements. The frequency of tinnitus was low but tended to be higher with salsalate therapy (n = 4 vs n = 2).Conclusions/interpretationIn summary, salsalate therapy was well tolerated, lowered fasting glucose, increased adiponectin and reduced adipose tissue NF-κB activity. These changes were not related to changes in peripheral insulin sensitivity, suggesting additional mechanisms for metabolic improvement.Trial registrationClinicalTrials.gov NCT00330733.FundingOffice of Research and Development, Medical Research Service, Department of Veterans Affairs and NIH K24 DK63214.

Dataset Information

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

Publications

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

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