The Pregnancy Environment and Lifestyle Study (PETALS): a population-based longitudinal multi-racial birth cohort.

BACKGROUND: Increasing recognition has been received regarding the proven and suggested links between multi-level environmental exposures on a broad scale (e.g., chemical, clinical, behavioral, physical and social) and health deficits originated from the critical window of development. However, such prospective human data are limited. In 2016, the National Institutes of Health funded 35 centers comprising 84 extant cohorts for the Environmental Influences on Child Health Outcomes (ECHO) pediatric cohorts program. The Pregnancy Environment and Lifestyle Study (PETALS) is one of the cohorts at the participating centers of Kaiser Permanente Northern California (KPNC). METHODS: PETALS was originally funded by the National Institute of Environmental Health Sciences to establish a longitudinal birth cohort of 3,350 mother-infant pairs and conduct a nested case-control study of 300 women with gestational diabetes (GDM) and 600 matched controls to investigate the associations between phenol exposures in first and second trimesters and GDM risk and the related outcome of infant macrosomia. This paper describes the prospective cohort design of PETALS, current research activities, and cohort profile of enrolled women who delivered as of February 2016. Women are enrolled from the KPNC membership. Fasting blood draw, urine collection, anthropometric measurements, and questionnaires on health history and lifestyle are completed at baseline and follow-up clinic visits with targeted windows of 10-13 and 16-19 weeks of gestation, respectively. Further, women's clinical and health assessments before and after the index pregnancy in addition to their children's birth outcomes and health information can be abstracted from electronic health records, allowing future follow-up. Study data could also be linked and extended to a myriad of additional observational data including environmental and area-level databases and census data. DISCUSSION: In this racially- and ethnically-diverse pregnancy cohort, the generated biospecimen and data repository will establish a comprehensive framework which may provide unique opportunities to address a multitude of research questions on the intrauterine environment and adverse pregnancy and birth outcomes in a representative multi-racial/ethnic population with generalizable findings.

A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: design and rationale of the Gestational Diabetes' Effects on Moms (GEM) study.

BACKGROUND: Women with gestational diabetes (GDM) are at high risk of developing diabetes later in life. After a GDM diagnosis, women receive prenatal care to control their blood glucose levels via diet, physical activity and medications. Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population. In the Gestational Diabetes' Effects on Moms (GEM) study, we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level. METHODS/DESIGN: The GEM study is a pragmatic cluster randomized clinical trial of 44 medical facilities at Kaiser Permanente Northern California randomly assigned to either the intervention or usual care conditions, that includes 2,320 women with a GDM diagnosis between March 27, 2011 and March 30, 2012. A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed. The effectiveness of this intervention added to usual care is to be compared to usual care practices alone, which includes two pages of printed lifestyle recommendations sent to postpartum women via mail. Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change. Secondary outcomes include postpartum glycemia, blood pressure, depression, percent of calories from fat, total caloric intake and physical activity levels. Data were collected through electronic medical records and surveys at baseline (soon after GDM diagnosis), 6 weeks (range 2 to 11 weeks), 6 months (range 12 to 34 weeks) and 12 months postpartum (range 35 to 64 weeks). DISCUSSION: There is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM, as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this population. Given the use of a telephonic case management model, our Diabetes Prevention Program-derived print/telephone intervention has the potential to be adopted in other settings and to inform policies to promote the prevention of diabetes among women with GDM.

The multigroup ethnic identity measure-revised: measurement invariance across racial and ethnic groups.

The Multigroup Ethnic Identity Measure-Revised (MEIM-R), a brief instrument assessing affiliation with one's ethnic group, is a promising advance in the ethnic identity literature. However, equivalency of its measurement properties across specific racial and ethnic groups should be confirmed before using it in diverse samples. We examined (a) the psychometric properties of the MEIM-R, including factor structure, measurement invariance, and internal consistency reliability, and (b) levels of and differences in ethnic identity across multiple racial and ethnic groups and subgroups. Asian (n = 630), Black/African American (n = 58), Hispanic (n = 240), multiethnic (n = 160), and White (n = 375) women completed the MEIM-R as part of the "Gestational diabetes' Effect on Moms" diabetes prevention trial in the Kaiser Permanente Northern California health care setting (N = 1,463; M age = 32.5 years, SD = 4.9). Multiple-groups confirmatory factor analyses provided provisional evidence of measurement invariance, i.e., an equal, correlated 2-factor structure, equal factor loadings, and equal item intercepts across racial and ethnic groups. Latent factor means for the 2 MEIM-R subscales, exploration and commitment, differed across groups; effect sizes ranging from small to large generally supported the notion of ethnic identity as more salient among people of color. Pending replication, good psychometric properties in this large and diverse sample of women support the future use of the MEIM-R. Preliminary evidence of measurement invariance suggests that the MEIM-R could be used to measure and compare ethnic identity across multiple racial and ethnic groups.

The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster Randomized Controlled Trial.

OBJECTIVE: To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)-derived lifestyle intervention. RESEARCH DESIGN AND METHODS: This study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI <25.0 kg/m(2) or 2) losing 5% of pregravid weight if BMI ≥25.0 kg/m(2); and pregravid to postpartum weight change. RESULTS: On average, over the 12-month postpartum period, women in the intervention had significantly higher odds of meeting weight goals than women in usual care (odds ratio [OR] 1.28 [95% CI 1.10, 1.47]). The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks (25.5 vs. 22.4%; OR 1.17 [1.01, 1.36]) and 6 months (30.6 vs. 23.9%; OR 1.45 [1.14, 1.83]). Condition differences were reduced at 12 months (33.0 vs. 28.0%; OR 1.25 [0.96, 1.62]). At 6 months, women in the intervention retained significantly less weight than women in usual care (mean 0.39 kg [SD 5.5] vs. 0.95 kg [5.5]; mean condition difference -0.64 kg [95% CI -1.13, -0.14]) and had greater increases in vigorous-intensity physical activity (mean condition difference 15.4 min/week [4.9, 25.8]). CONCLUSIONS: A DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity.