A Pragmatic, Randomized Clinical Trial of Gestational Diabetes Screening.

BACKGROUND: Gestational diabetes mellitus is common and is associated with an increased risk of adverse maternal and perinatal outcomes. Although experts recommend universal screening for gestational diabetes, consensus is lacking about which of two recommended screening approaches should be used. METHODS: We performed a pragmatic, randomized trial comparing one-step screening (i.e., a glucose-tolerance test in which the blood glucose level was obtained after the oral administration of a 75-g glucose load in the fasting state) with two-step screening (a glucose challenge test in which the blood glucose level was obtained after the oral administration of a 50-g glucose load in the nonfasting state, followed, if positive, by an oral glucose-tolerance test with a 100-g glucose load in the fasting state) in all pregnant women who received care in two health systems. Guidelines for the treatment of gestational diabetes were consistent with the two screening approaches. The primary outcomes were a diagnosis of gestational diabetes, large-for-gestational-age infants, a perinatal composite outcome (stillbirth, neonatal death, shoulder dystocia, bone fracture, or any arm or hand nerve palsy related to birth injury), gestational hypertension or preeclampsia, and primary cesarean section. RESULTS: A total of 23,792 women underwent randomization; women with more than one pregnancy during the trial could have been assigned to more than one type of screening. A total of 66% of the women in the one-step group and 92% of those in the two-step group adhered to the assigned screening. Gestational diabetes was diagnosed in 16.5% of the women assigned to the one-step approach and in 8.5% of those assigned to the two-step approach (unadjusted relative risk, 1.94; 97.5% confidence interval [CI], 1.79 to 2.11). In intention-to-treat analyses, the respective incidences of the other primary outcomes were as follows: large-for-gestational-age infants, 8.9% and 9.2% (relative risk, 0.95; 97.5% CI, 0.87 to 1.05); perinatal composite outcome, 3.1% and 3.0% (relative risk, 1.04; 97.5% CI, 0.88 to 1.23); gestational hypertension or preeclampsia, 13.6% and 13.5% (relative risk, 1.00; 97.5% CI, 0.93 to 1.08); and primary cesarean section, 24.0% and 24.6% (relative risk, 0.98; 97.5% CI, 0.93 to 1.02). The results were materially unchanged in intention-to-treat analyses with inverse probability weighting to account for differential adherence to the screening approaches. CONCLUSIONS: Despite more diagnoses of gestational diabetes with the one-step approach than with the two-step approach, there were no significant between-group differences in the risks of the primary outcomes relating to perinatal and maternal complications. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ScreenR2GDM ClinicalTrials.gov number, NCT02266758.).

Impact of Maternal Glucose and Gestational Weight Gain on Child Obesity over the First Decade of Life in Normal Birth Weight Infants.

Objective To determine, among children with normal birth weight, if maternal hyperglycemia and weight gain independently increase childhood obesity risk in a very large diverse population. Methods Study population was 24,141 individuals (mothers and their normal birth weight offspring, born 1995-2003) among a diverse population with universal GDM screening [50-g glucose-challenge test (GCT); 3 h. 100 g oral glucose tolerance test (OGTT) if GCT+]. Among the 13,037 full-term offspring with normal birth weight (2500-4000 g), annual measured height/weight was ascertained between ages 2 and 10 years to calculate gender-specific BMI-for-age percentiles using USA norms (1960-1995 standard). Results Among children who began life with normal birth weight, we found a significant trend for developing both childhood overweight (>85 %ile) and obesity (>95 %ile) during the first decade of life with both maternal hyperglycemia (normal GCT, GCT+ but no GDM, GDM) and excessive gestational weight gain [>40 pounds (18.1 kg)]; p < 0.0001 for both trends. These maternal glucose and/or weight gain effects to imprint for childhood obesity in the first decade remained after adjustment for potential confounders including maternal age, parity, as well as pre-pregnancy BMI. The attributable risk (%) for childhood obesity was 28.5 % (95 % CI 15.9-41.1) for GDM and 16.4 % (95 % CI 9.4-23.2) for excessive gestational weight gain. Conclusions for Practice Both maternal hyperglycemia and excessive weight gain have independent effects to increase childhood obesity risk. Future research should focus on prevention efforts during pregnancy as a potential window of opportunity to reduce childhood obesity.

First year infant weight trajectories predict overweight/obesity at age 2 in a diverse population.

BACKGROUND: Obesity is emerging as early as two years of age and risk may be elucidated by differences in infant growth trajectories. We examined infant weight gain in the first year of life and association with overweight/obesity at age two. METHODS: In a diverse, population-based cohort study we conducted growth curve analysis using Health Maintenance Organization electronic medical record data from January 1, 2012 through December 31, 2013. RESULTS: Among 930 infants, there was a linear relationship with birth weight and initial weight gain from birth and increased odds of developing overweight/obesity at age two [Odds Ratio OR = 1.001; (95% CI: 1.000-1.002), p = 0.0274] and [OR = 1.009; (1.006-1.01), p = 0.0001) respectively. The odds of becoming overweight/obese at age 2 increased in infants who had slower weight deceleration rates (OR third quartile = 2.78, fourth quartile = 4.3) compared to the first quartile. Other factors associated with overweight/obesity risk at age two included female sex and Native Hawaiian race/ethnicity. CONCLUSIONS: Rate of weight gain in the first year may be an important risk factor for early childhood obesity. A deeper dive into first year growth patterns and related sociocultural and nutritional factors is needed to inform targetable points for intervention.

Lung Cancer Screening by Race and Ethnicity in an Integrated Health System in Hawaii.

Importance: Racial and ethnic differences in lung cancer screening (LCS) completion and follow-up may be associated with lung cancer incidence and mortality rates among high-risk populations. Aggregation of Asian American, Native Hawaiian, and Pacific Islander racial and ethnic groups may mask the true underlying disparities in screening uptake and diagnostic follow-up, creating barriers for targeted, preventive health care. Objective: To examine racial and ethnic differences in LCS completion and follow-up rates in a multiethnic population. Design, Setting, and Participants: This population-based cohort study was conducted at a health maintenance organization in Hawaii. LCS program participants were identified using electronic medical records from January 1, 2015, to December 31, 2019. Study eligibility requirements included being aged 55 to 79 years, a 30 pack-year smoking history, a current smoker or having quit within the past 15 years, at least 5 years past any lung cancer diagnosis and treatment, and cancer free. Data analysis was performed from June 2019 to October 2020. Exposure: Eligible for LCS. Main Outcomes and Measures: Screening rates were analyzed by self-reported race and ethnicity and completion of a low-dose computed tomography (LDCT) test. Diagnostic follow-up results were based on the Lung Imaging Reporting and Data System (Lung-RADS) staging system. Results: A total of 1030 eligible LCS program members had an order placed; their mean (SD) age was 65.5 (5.8) years, and 633 (61%) were men. The largest racial and ethnic groups were non-Hispanic White (381 participants [37.0%]), Native Hawaiian or part Native Hawaiian (186 participants [18.1%]), and Japanese (146 participants [14.2%]). Men and Filipino, Chinese, Japanese, and non-Hispanic White individuals had a higher proportion of screen orders for LDCT compared with women and individuals of the other racial and ethnic groups. The overall LCS completion rate was 81% (838 participants). There was a 14% to 15% screening completion rate gap among groups. Asian individuals had the highest screening completion rate (266 participants [86%]) followed by Native Hawaiian (149 participants [80%]) and non-Hispanic White individuals (305 participants [80%]), Pacific Islander (50 participants [79%]) individuals, and individuals of other racial and ethnic groups (68 participants [77%]). Within Asian subgroups, Korean (31 participants [94%]) and Japanese (129 participants [88%]) individuals had the highest completion rates followed by Chinese individuals (28 participants [82%]) and Filipino individuals (78 participants [79%]). Of the 54 participants with Lung-RADS stage 3 disease, 93% (50 participants) completed a 6-month surveillance LDCT test; of 37 individuals with Lung-RADS stage 4 disease, 35 (97%) were followed-up for additional procedures. Conclusions and Relevance: This cohort study found racial and ethnic disparities in LCS completion rates after disaggregation of Native Hawaiian, Pacific Islander, and Asian individuals and their subgroups. These findings suggest that future research is needed to understand factors that may be associated with LCS completion and follow-up behaviors among these racial and ethnic groups.

Timing of Gestational Diabetes Diagnosis by Maternal Obesity Status: Impact on Gestational Weight Gain in a Diverse Population.

Background: We hypothesized that earlier gestational diabetes mellitus (GDM) diagnosis and treatment of high-risk women would reduce gestational weight gain (GWG) in the first trimester and overall. Materials and Methods: We evaluated timing of GDM diagnosis among 5,391 pregnant women who delivered singleton births 2010-2013 in a large diverse health maintenance organization (HMO). All GDM screening was by the same oral glucose tolerance testing protocol; GDM treatment protocols were also consistent irrespective of timing of diagnosis. Women without risk factors were universally screened at 24-28 weeks gestation (Usual). Early screening was recommended in obese and other high-risk women at the first prenatal visit; those who screened negative Early were rescreened at 24-28 weeks (Early+Usual). Results: Average GWG for all women was 12.8 kg; 10.7% of women were diagnosed with GDM. Average GWG for all women diagnosed with GDM was 10.7 kg, adjusted for gestational age. Women with EarlyGDM averaged 2.4 kg less GWG than women diagnosed with UsualGDM (p < 0.0001). Among obese women, only women diagnosed with EarlyGDM averaged overall GWG within Institute of Medicine (IOM) weight guidelines (mean 8.1 kg) and were weight neutral in the first trimester (-0.2 kg). Overall, 43% of all pregnant women exceeded IOM GWG guidelines (gained more total weight than recommended); 60% of obese women exceeded guidelines. Obese women diagnosed with GDM were less likely to exceed IOM guidelines if diagnosed earlier in pregnancy (35% EarlyGDM vs. 59% UsualGDM exceeded guidelines, p < 0.0001). Conclusion: Our results suggest that EarlyGDM diagnosis (and thus treatment) in high-risk women is beneficial for optimizing GWG.

A randomized pragmatic clinical trial of gestational diabetes screening (ScreenR2GDM): Study design, baseline characteristics, and protocol adherence.

BACKGROUND: ScreenR2GDM is a pragmatic randomized clinical trial designed to investigate if one of two gestational diabetes (GDM) screening and treatment protocols results in improved outcomes in the context of standard clinical care. METHODS: Pregnant women are randomized to one of two GDM screening strategies: 1-step: 2-h, 75 g, oral glucose tolerance test (OGTT) or 2-step: 1-h, 50 g glucose challenge test (GCT) followed by 3-h, 100 g OGTT if GCT-positive. Providers are prompted within the electronic medical record to order the assigned test but were given the option to order the alternate test. Collected data include maternal and pregnancy characteristics, GDM testing, and outcomes for mother and newborn. We describe the study design and baseline characteristics and evaluate characteristics associated with adhering to the randomized protocol. RESULTS: Baseline characteristics of the 23,792 randomized pregnancies were comparable between the two groups. Adherence to assigned test differed between the two strategies: 66.1% for 1-step and 91.7% for 2-step (p < .0001). 27% of the women randomized to receive the 1-step completed the 2-step test vs 2% randomized to the 2-step who completed the 1-step (p < .0001). Patient characteristics related to adherence included obesity, age, prior GDM, Medicaid insurance, race and nulliparity. Clinician characteristics related to adherence included provider type, age and gender. CONCLUSIONS: Both patient and provider characteristics were related to adherence to the randomized GDM screening protocol. Analytical techniques that incorporate these findings into the formal evaluation of the two protocols on GDM-associated outcomes will be necessary to account for potential biases introduced by non-adherence.

Fall Ascertainment and Development of a Risk Prediction Model Using Electronic Medical Records.

OBJECTIVES: To examine the use of electronic medical record (EMR) data to ascertain falls and develop a fall risk prediction model in an older population. DESIGN: Retrospective longitudinal study using 10 years of EMR data (2004-2014). A series of 3-year cohorts included members continuously enrolled for a minimum of 3 years, requiring 2 years pre-fall (no previous record of a fall) and a 1-year fall risk period. SETTING: Kaiser Permanente Hawaii, an ambulatory setting. PARTICIPANTS: A total of 57 678 adults, age 60 years and older. MEASUREMENTS: Initial EMR searches were guided by current literature and geriatricians to understand coding sources of falls as our outcome. Falls were captured by two coding sources: International Classification of Diseases, Ninth Revision (ICD-9) codes (E880-889) and/or a fall listed as a "primary reason for visit." A comprehensive list of EMR predictors of falls were included into prediction models enabling statistical subset selection from many variables and modeling by logistic regression. RESULTS: Although 72% of falls in the training data set were coded as "primary reason for visit," 22% of falls were coded as ICD-9 and 6% coded as both. About 80% were reported in face-to-face encounters (eg, emergency department). A total of 2164 individuals had a fall in the risk period. Using the 13 key predictors (age, comorbidities, female sex, other mental disorder, walking issues, Parkinson's disease, urinary incontinence, depression, polypharmacy, psychotropic and anticonvulsant medications, osteoarthritis, osteoporosis) identified through LASSO regression, the final model had a sensitivity of 67%, specificity of 69%, positive predictive value of 8%, negative predictive value of 98%, and area under the curve of .74. CONCLUSION: This study demonstrated how the EMR can be used to ascertain falls and develop a fall risk prediction model with moderate sensitivity/specificity. Concurrent work with clinical providers to enhance fall documentation will improve the ability of the EMR to capture falls and consequently may improve the model to predict fall risk.

Race/Ethnic Differences in Birth Size, Infant Growth, and Body Mass Index at Age Five Years in Children in Hawaii.

BACKGROUND: Factors at birth and infancy may increase risk of being overweight in childhood. The aim of this study was to examine the relationship of birth size and infant growth (2-24 months) with BMI at age 5 years in a multiethnic population. METHODS: This was a retrospective study (using electronic medical records of a health maintenance organization in Hawaii) of singleton children born in 2004-2005, with linked maternal and birth information, infant weights (n = 597) and lengths (n = 473) in the first 2 years, and BMI measures at age 5 years (n = 894). Multiple regression models were used to estimate the association of BMI at age 5 years with birth size and infant growth. RESULTS: Birth weight was positively associated with BMI at age 5 years, adjusting for gestational age, sex, race/ethnicity, and maternal prepregnancy weight, age, education, and smoking. A greater change in infant weight was associated with a higher BMI at age 5 years, though the effect of birth weight on BMI was neither mediated nor modified by infant growth rate. Birth weight, change in infant weight, and BMI at age 5 years varied by race/ethnicity. Change in infant BMI in the first 2 years was higher in other Pacific Islanders and whites (Δ = 0.966; confidence interval [CI] = 0.249-1.684; p = 0.02) than in Asian, other, and part Native Hawaiian race/ethnic groups. CONCLUSIONS: Early biological measures of birth weight and infant weight gain varied by race/ethnicity and positively predicted BMI at age 5 years.

US acculturation is associated with health behaviors and obesity, but not their change, with a hotel-based intervention among Asian-Pacific Islanders.

BACKGROUND: Immigration to the United States has been associated with obesity, yet the relationship of acculturation to obesity and energy balance (ie, physical activity/dietary intake) in adults is a complex issue. Limited longitudinal data are available on immigrant Asians and Pacific Islanders. DESIGN: Analyses were conducted on baseline data and change data from baseline to 24 months in the hotel-based cluster-randomized Work, Weight and Wellness trial involving 15 control and 15 intervention hotels on the island of Oahu, Hawaii. SAMPLE: Participants were adult employees of predominantly Asian and Pacific Islander ancestry who were assessed one or more times over the course of 24 months. The full sample consisted of 4,236 hotel workers (about 40% of hotel workforce) at baseline, 3,502 hotel workers at Year 1 and 2,963 hotel workers at the 24-month follow up. One thousand one hundred fifteen hotel workers had at least two measurements, and were included in the analysis. INTERVENTION: The Work, Weight, and Wellness trial was designed to promote weight loss via motivation and support for increases in physical activity and increased access to and consumption of healthy low-fat/low-energy foods. The measure of acculturation consisted of a score that was a compilation of a participant's age when he or she immigrated to the United States, country of birth, language spoken at home, and years of education. STATISTICAL ANALYSES: We used mixed effect regression models for cross-sectional baseline models and longitudinal multilevel regression analysis of change in diet and physical activity behaviors and obesity over time using a random intercept. Estimates of the intervention effect are expressed as an annual rate of change for all study outcomes. RESULTS: At baseline acculturation was positively associated with body mass index; physical activity level; and fruit, meat, and sweetened drink intake level. In analyses of change across 24 months, acculturation did not significantly influence change in dietary intake or indexes of obesity (ie, body mass index or waist-to-height ratio). However physical activity increased significantly more in the intervention group during the course of the intervention compared with the control group, which decreased activity, when sociodemographic factors (including acculturation) and food intake behavior were controlled for.

US acculturation, food intake, and obesity among Asian-Pacific hotel workers.

BACKGROUND: Both obesity and immigration continue to increase in the United States. Studies suggest that a transition in lifestyle patterns, such as food intake, may mediate the relationship between immigration and obesity. OBJECTIVE: We examine obesity among hotel workers in relation to age, sex, race/ethnicity, and indicators of food intake, immigration, and acculturation. SUBJECTS/SETTING: Four thousand five hundred thirty hotel workers in 30 hotels were studied from the first year of the Work, Weight and Wellness program, before intervention (during 2005-2006). MAIN OUTCOME MEASURES: Weight and height were measured, whereas race/ethnicity, language, education, immigration, acculturation, and food intake variables were assessed by questionnaire. RESULTS: The study included 43% male and 57% female hotel workers (mean age 44.4+/-11.3 years; 42% Filipino, 32% other Asian, 13% Pacific Islander, 9% white, 1% black/African American, and 3% other race/ethnicity). On average (mean value), 55% of participants were born outside the United States; 57% were overweight or obese (body mass index [BMI] >25). The BMI of those born in the United States was 1.3 higher than that of those born in another country, adjusting for sex and race/ethnicity. Intake of sweet drinks and meat was positively associated with BMI while intake of fruit was negatively associated with BMI. Age at arrival in United States ("generation") was negatively associated with BMI, whereas greater acculturation was positively associated with BMI. CONCLUSIONS: Food intake behaviors are probably related to place of birth, generation of migration to the United States, and acculturation. Direct measures of food intake added explanatory power to models, suggesting the importance of food intake to obesity. Further study of the influence of immigration, acculturation, and food intake on obesity using longitudinal study designs is warranted.