• A Pilot Study to Assess the Feasibility, Safety and Acceptability of Soy-based Diet for Pregnant Women at High Risk for Gestational Diabetes Mellitus

      Shi, Ling; Iyer, Vidya; Jones, Emily; Moore Simas, Tiffany A.; Lichtenstein, Alice H.; Hayman, Laura L. (2016-05-20)
      Background: Diet plays an important role in the prevention and management of gestational diabetes mellitus (GDM). Previous studies suggest that soy protein and isoflavones may have beneficial effects on lipid and glucose metabolism. Little is known regarding the cardiometabolic effects of soy intake during pregnancy. This pilot study assessed the feasibility, safety and acceptability of daily consumption of soy foods during pregnancy in women at high risk for GDM, and participant adherence to their assigned treatment. Methods: A randomized controlled trial (RCT) was conducted among pregnant women at high risk for GDM. The Soy group were counseled to consume a combination of foods designed to contain ~25 grams of soy protein and 60-75 mg of isoflavones daily from 14 weeks until birth. They were provided with recipes and contents of different soy foods. The Control group maintained their regular diet while minimizing intake of soy containing foods. Assessments, conducted at 14 and 28 weeks of pregnancy, and 6 week postpartum, included physical measurement, questionnaire, and fasting blood samples for lipid, glucose and isoflavone metabolism biomarkers. Monthly follow-up calls were conducted to assess safety and encourage adherence. Results: Twenty-nine subjects were recruited over a 10 month period. Both Soy and Control groups demonstrated high adherence (80-90%), defined as ≥ 15 days consuming soy foods in the past four weeks for soy group and ≤ 5 days for controls. Only five adverse events were reported possibly associated with soy intake, including nausea, vomiting, diarrhea, and itchy mouth. They were all transient and resolved without sequelae. Conclusion: Although adherence can be challenging in such a trial, this study used a variety of approaches such as recommended recipes, dietician consultation, and monthly follow-up calls to enhance feasibility and compliance. Results indicated feasibility and adherence to treatment assignment, including the soy-based diet intervention.
    • Caste Matters: Perceived Discrimination among Women in Rural India

      Soni, Apurv; Khubchandani, Jasmine A.; Fahey, Nisha; Raithatha, Nitin; Prabhakaran, Anusha; Byatt, Nancy; Moore Simas, Tiffany A.; Phatak, Ajay; Rosal, Milagros C.; Nimbalkar, Somashekhar; et al. (2017-05-16)
      Purpose: To examine the relationship of caste and class with perceived discrimination among pregnant women from rural western India. Methods: A cross-sectional survey was administered to 170 pregnant women in rural Gujarat, India, who were enrolled in a longitudinal cohort study. Everyday Discrimination Scale and Experiences of Discrimination questionnaires were used to assess perceived discrimination and response to discrimination. Based on self-reported caste, women were classified to three categories with increasing historical disadvantage: General, Other Backward Castes (OBC), and Scheduled Caste or Tribes (SC/ST). Socioeconomic class was determined using standardized Kuppuswamy scale. Regression models for count and binomial data were used to examine association of caste and class with experience of discrimination and response to discrimination. Results: 68% of women experienced discrimination. After adjusting for confounders, there was a consistent trend and association of discrimination with caste but not class. In comparison to General Caste, lower caste (OBC, SC/ST) women were more likely to 1) experience discrimination (OBC OR: 2.2, SC/ST: 4.1; p-trend: 0.01), 2) have a greater perceived discrimination score (OBC IRR: 1.3, SC/ST: 1.5; p-trend: 0.07), 3) accept discrimination (OBC OR: 6.4, SC/ST: 7.6; p-trend: < 0.01), and 4) keep to herself about discrimination (OBC OR: 2.7, SC/ST: 3.6; p-trend: 0.04). Conclusion: The differential experience of discrimination by lower caste women in comparison to upper caste women and their response to such experiences highlight the importance of studying discrimination to understand existing caste-based disparities.
    • Factors That Matter to Low-Income and Racial/Ethnic Minority Mothers When Choosing a Pediatric Practice: a Mixed Methods Analysis

      Goff, Sarah L.; Mazor, Kathleen M.; Guhn-Knight, Haley; Budway, Yara Youssef; Murphy, Lorna; White, Katharine O.; Lagu, Tara; Pekow, Penelope S.; Priya, Aruna; Lindenauer, Peter K. (2017-03-08)
      BACKGROUND: Pediatric practices' scores on healthcare quality measures are increasingly available to the public. However, patients from low-income and racial/ethnic minority populations rarely use these data. We sought to understand potential barriers to using quality data by assessing what factors mattered to women when choosing a pediatric practice. METHODS: As part of a randomized trial to overcome barriers to using quality data, we recruited women from a prenatal clinic serving an underserved population. Women reported how much 12 factors mattered when they chose a pediatric practice (5-point Likert scale), what other factors mattered to them, and which factors mattered the most. We assessed whether factor importance varied with selected participant characteristics and qualitatively analyzed the "other" factors named. RESULTS: Participants' (n = 367) median age was 23 years, and they were largely Hispanic (60.4%), white (21.2%), or black (16.9%). Insurance acceptance "mattered a lot" to the highest percentage of women (93.2%), while online information about what other parents think of a practice "mattered a lot" to the fewest (7.4%). Major themes from our qualitative analysis of "other" factors that mattered included physicians' interpersonal skills and pediatrician-specific traits. Factors related to access "mattered the most" to the majority of women. CONCLUSIONS: Pediatrician characteristics and factors related to access to care may be more important to low-income and racial/ethnic minority women than more commonly reported quality metrics. Aligning both the content and delivery of publicly reported quality data with women's interests may increase use of pediatric quality data. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT01784575.
    • Feasibility, Safety and Acceptability of Soy-Based Diet for Pregnant Women: Preliminary Results from a Pilot Randomized Controlled Trial

      Shi, Ling; Iyer, Vidya; Norwitz, Errol; Moore Simas, Tiffany A.; Matthan, Nirupa R.; Lichtenstein, Alice H.; Hayman, Laura L. (2017-05-16)
      Background: Previous evidence suggests that soy containing foods may have beneficial effects on lipid and glycemic metabolism. Pregnancy is associated with a progressive deterioration in glucose and lipid metabolism, partially attributable to elevated estrogen concentrations. Little is known about the effects of soy intake on cardiometabolic risk factors in pregnant women. Methods: A pilot RCT was conducted in 30 pregnant women who were randomized to receive counseling to consume a high-soy or low-soy foods containing diet. Assessments (physical measurements, food frequency questionnaires, fasting blood samples) were conducted at 14 and 28 weeks of pregnancy, and 6 weeks’ postpartum. Monthly follow-up calls were conducted to assess safety and encourage adherence. Results: Both the high-soy and low-soy groups demonstrated high adherence (80-90%), defined as consuming soy foods ≥ 15 days in the past four weeks for high-soy group and ≤ 5 days for low-soy group. Five adverse events possibly associated with soy intake were reported (nausea, vomiting, diarrhea, itchy mouth); all were transient and resolved without sequelae. The high-soy group lost body fat between baseline and postpartum while the low-soy group gained body fat, as reflected by change in triceps skinfold thickness (-4.8 mm vs +3.6 mm, p=0.04). There was a trend towards an improvement in BMI in the high-soy group, both at 28 weeks (+1.4 vs. +3.6 kg/m2, p=0.15) and postpartum (-1.2 vs. +0.6 kg/m2, p=0.14). There were no differences between groups in fasting glucose, HDL-C, LDL-C, TG, or VLDL levels. Conclusion: Initial results from this pilot RCT support the acceptability and safety of consuming soy-based whole foods during pregnancy. A larger-scale RCT is needed to further elucidate the effects of soy diet on cardiometabolic risk among pregnant women.
    • Screening for Elevated Blood Lead Levels in Children and Pregnant Women: US Preventive Services Task Force Recommendation Statement

      US Preventive Services Task Force; Curry, Susan J.; Pbert, Lori; Wong, John B. (2019-04-16)
      Importance: Elevated blood lead levels in children are associated with neurologic effects such as behavioral and learning problems, lower IQ, hyperactivity, hearing problems, and impaired growth. In pregnant women, lead exposure can impair organ systems such as the hematopoietic, hepatic, renal, and nervous systems, and increase the risk of preeclampsia and adverse perinatal outcomes. Many of the adverse health effects of lead exposure are irreversible. Objective: To update the 2006 US Preventive Services Task Force (USPSTF) recommendation on screening for elevated blood lead levels in children and pregnant women. Evidence Review: The USPSTF reviewed the evidence on the benefits and harms of screening for and treatment of elevated blood lead levels. In this update, an elevated blood lead level was defined according to the Centers for Disease Control and Prevention reference level of 5 mug/dL. Findings: The USPSTF found adequate evidence that questionnaires and other clinical prediction tools to identify asymptomatic children with elevated blood lead levels are inaccurate. The USPSTF found adequate evidence that capillary blood testing accurately identifies children with elevated blood lead levels. The USPSTF found inadequate evidence on the effectiveness of treatment of elevated blood lead levels in asymptomatic children 5 years and younger and in pregnant women. The USPSTF found inadequate evidence regarding the accuracy of questionnaires and other clinical prediction tools to identify asymptomatic pregnant women with elevated blood lead levels. The USPSTF found inadequate evidence on the harms of screening for or treatment of elevated blood lead levels in asymptomatic children and pregnant women. The USPSTF concluded that the current evidence is insufficient, and that the balance of benefits and harms of screening for elevated blood lead levels in asymptomatic children 5 years and younger and in pregnant women cannot be determined. Conclusions and Recommendation: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for elevated blood lead levels in asymptomatic children. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for elevated blood lead levels in asymptomatic pregnant persons. (I statement).
    • Why pregnant women with depression often slip through the cracks

      Moore Simas, Tiffany A.; Byatt, Nancy (2018-06-06)
      One in seven women experience depression during pregnancy and after they give birth. This article explains how a model the authors created in Massachusetts to ensure that women with depression get the help they need is being implemented in other states.