Rates of Downstream Procedures and Complications Associated With Lung Cancer Screening in Routine Clinical Practice : A Retrospective Cohort Study.

BACKGROUND: Lung cancer screening (LCS) using low-dose computed tomography (LDCT) reduces lung cancer mortality but can lead to downstream procedures, complications, and other potential harms. Estimates of these events outside NLST (National Lung Screening Trial) have been variable and lacked evaluation by screening result, which allows more direct comparison with trials. OBJECTIVE: To identify rates of downstream procedures and complications associated with LCS. DESIGN: Retrospective cohort study. SETTING: 5 U.S. health care systems. PATIENTS: Individuals who completed a baseline LDCT scan for LCS between 2014 and 2018. MEASUREMENTS: Outcomes included downstream imaging, invasive diagnostic procedures, and procedural complications. For each, absolute rates were calculated overall and stratified by screening result and by lung cancer detection, and positive and negative predictive values were calculated. RESULTS: Among the 9266 screened patients, 1472 (15.9%) had a baseline LDCT scan showing abnormalities, of whom 140 (9.5%) were diagnosed with lung cancer within 12 months (positive predictive value, 9.5% [95% CI, 8.0% to 11.0%]; negative predictive value, 99.8% [CI, 99.7% to 99.9%]; sensitivity, 92.7% [CI, 88.6% to 96.9%]; specificity, 84.4% [CI, 83.7% to 85.2%]). Absolute rates of downstream imaging and invasive procedures in screened patients were 31.9% and 2.8%, respectively. In patients undergoing invasive procedures after abnormal findings, complication rates were substantially higher than those in NLST (30.6% vs. 17.7% for any complication; 20.6% vs. 9.4% for major complications). LIMITATION: Assessment of outcomes was retrospective and was based on procedural coding. CONCLUSION: The results indicate substantially higher rates of downstream procedures and complications associated with LCS in practice than observed in NLST. Diagnostic management likely needs to be assessed and improved to ensure that screening benefits outweigh potential harms. PRIMARY FUNDING SOURCE: National Cancer Institute and Gordon and Betty Moore Foundation.

Uptake of Lung Cancer Screening CT After a Provider Order for Screening in the PROSPR-Lung Consortium.

BACKGROUND: Uptake of lung cancer screening (LCS) has been slow with less than 20% of eligible people who currently or formerly smoked reported to have undergone a screening CT. OBJECTIVE: To determine individual-, health system-, and neighborhood-level factors associated with LCS uptake after a provider order for screening. DESIGN AND SUBJECTS: We conducted an observational cohort study of screening-eligible patients within the Population-based Research to Optimize the Screening Process (PROSPR)-Lung Consortium who received a radiology referral/order for a baseline low-dose screening CT (LDCT) from a healthcare provider between January 1, 2015, and June 30, 2019. MAIN MEASURES: The primary outcome is screening uptake, defined as LCS-LDCT completion within 90 days of the screening order date. KEY RESULTS: During the study period, 18,294 patients received their first order for LCS-LDCT. Orders more than doubled from the beginning to the end of the study period. Overall, 60% of patients completed screening after receiving their first LCS-LDCT order. Across health systems, uptake varied from 41 to 87%. In both univariate and multivariable analyses, older age, male sex, former smoking status, COPD, and receiving care in a centralized LCS program were positively associated with completing LCS-LDCT. Unknown insurance status, other or unknown race, and lower neighborhood socioeconomic status, as measured by the Yost Index, were negatively associated with screening uptake. CONCLUSIONS: Overall, 40% of patients referred for LCS did not complete a LDCT within 90 days, highlighting a substantial gap in the lung screening care pathway, particularly in decentralized screening programs.

Incidence and Survival for Patients Diagnosed With Breast, Colorectal, and Lung Cancer in an Integrated System.

INTRODUCTION: Documenting trends in cancer incidence and survival is a national priority. This study estimated age- and sex-adjusted incidence and 5-year relative survival among patients with cancer diagnosed within Kaiser Permanente compared to Surveillance, Epidemiology, and End Results (SEER) estimates. METHODS: The cohort included Kaiser Permanente health plan members diagnosed with breast (BC), colorectal (CRC), or lung cancer (LC) between January 1, 1999 and December 31, 2018. Incidence was computed as age-adjusted rates per 100,000 member-years. SEER*Stat was used to compute 5-year relative survival. RESULTS: Kaiser Permanente BC incidence rates were persistently higher than SEER from 2004 (126.5 [95% confidence interval (CI) = 123.2-129.9] vs 122.6 [95% CI = 121.3-123.2]) through 2013 (132.06 [95% CI = 129.5-135.7] vs 126.7 [95% CI = 125.9-127.5]). Kaiser Permanente CRC and LC incidence rates were lower than SEER for all years except 2008, showing a spike in CRC incidence (51.5 [95% CI = 49.9-53.0] vs 46.1 [95% CI = 45.7-46.4]). Kaiser Permanente BC, CRC, and LC survival estimates for all stages were higher than SEER. CONCLUSIONS: Incidence rates for all-stage and localized-stage BC were consistently higher for Kaiser Permanente than for SEER. CRC and LC rates were lower. Kaiser Permanente survival rates were consistently higher than for SEER. The strengths of these findings are associated with the ability to capture "gold-standard" cancer registry data on defined Kaiser Permanente populations. However, findings should be interpreted cautiously given differences in the underlying populations and secular and regional differences between Kaiser Permanente and SEER. The Kaiser Permanente population is younger and more racially diverse than SEER aggregate populations, and Kaiser Permanente members are insured with access to preventive care (eg, smoking cessation programs, cancer screening).

Individuals Eligible for Lung Cancer Screening Less Likely to Receive Screening When Enrolled in Health Plans With Deductibles.

BACKGROUND: In 2015, the Centers for Medicare & Medicaid Services and commercial insurance plans began covering lung cancer screening (LCS) without patient cost-sharing for all plans. We explore the impact of enrolling into a deductible plan on the utilization of LCS services despite having no out-of-pocket cost requirement. METHODS: This retrospective study analyzed data from the Population-based Research to Optimize the Screening Process Lung Consortium. Our cohort included non-Medicare LCS-eligible individuals enrolled in managed care organizations between February 5, 2015, and February 28, 2019. We estimate a series of sequential logistic regression models examining utilization across the sequence of events required for baseline LCS. We report the marginal effects of enrollment into deductible plans compared with enrollment in no-deductible plans. RESULTS: The total effect of deductible plan enrollment was a 1.8 percentage-point (PP) decrease in baseline LCS. Sequential logistic regression results that explore each transition separately indicate deductible plan enrollment was associated with a 4.3 PP decrease in receipt of clinician visit, a 1.7 PP decrease in receipt of LCS order, and a 7.0 PP decrease in receipt of baseline LCS. Reductions persisted across all observable races and ethnicities. CONCLUSIONS: These findings suggest individuals enrolled in deductible plans are more likely to forgo preventive LCS services despite requiring no out-of-pocket costs. This result may indicate that increased cost-sharing is associated with suboptimal choices to forgo recommended LCS. Alternatively, this effect may indicate individuals enrolling into deductible plans prefer less health care utilization. Patient outreach interventions at the health plan level may improve LCS.

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.

Weight changes according to treatment in a diverse cohort of breast cancer patients.

BACKGROUND: Weight changes are common among breast cancer patients. The majority of studies to date have focused on weight gain after a breast cancer diagnosis and its implications on health in survivors. Fewer studies have examined weight loss and its related characteristics. Weight changes have been reported to be influenced by several factors such as age, treatment, stage and pre-diagnostic weight. We evaluated weight changes during key treatment time points in early stage breast cancer patients. METHODS: We characterized 389 female patients diagnosed in Hawaii with early stage breast cancer from 2003 to 2017 in the Multiethnic Cohort (MEC) linked with Kaiser Permanente Hawaii electronic medical record data. We evaluated weight changes from surgery to 4 years post-diagnosis with six time points along a patient's treatment trajectory (chemotherapy, radiation, endocrine, or surgery alone) and annually thereafter, adjusting for age, race/ethnicity and initial body mass index (BMI). RESULTS: We found key time points of significant weight change for breast cancer patients according to their adjuvant treatment. In patients who had surgery alone (S), surgery-radiation (SR), or surgery-endocrine therapy (SE), the majority of patients had stable weight, although this consistently decreased over time. However, the percentages of patients with weight loss and weight gain during this time steadily increased up to 4 years after initial surgery. Weight loss was more common than weight gain by about 2 fold in these treatment groups. For patients with surgery-chemotherapy (SC), there was significant weight loss seen within the first 3 months after surgery, during the time when patients receive chemotherapy. And this weight loss persisted until year 4. Weight gain was less commonly seen in this treatment group. CONCLUSIONS: We identified key time points during breast cancer treatment that may provide a therapeutic window to positively influence outcomes. Tailored weight management interventions should be utilized to promote overall health and long term survivorship.

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.).

Characteristics of adults with overweight and obesity who have not attempted weight loss in the prior 12 months.

OBJECTIVE: To determine weight-related characteristics of adults with overweight or obesity who had not attempted weight loss in the prior 12 months. METHODS: Adults from the obesity cohort of the PORTAL clinical data research network were randomly selected to complete a survey in 2015. It included topics of experiences with health care providers, weight history, and health-promoting behaviors. RESULTS: A total of 2811 adults completed the survey, of whom 24% reported not attempting weight loss in the previous 12 months. Controlling for sociodemographic characteristics and body mass index, respondents who reported that their health care provider never talked about weight were more likely to not attempt weight loss in the previous 12 months compared with respondents who reported providers frequently brought up weight (OR: 0.45; 95% CI: 0.24, 0.66). Respondents who perceived themselves as normal weight or underweight were 4.22 times more likely (95% CI: 3.53, 5.05) to not attempt weight loss compared with respondents who perceived themselves as overweight. Respondents who reported that they never tried to lose at least 10 lbs, ate 0-2 servings of fruits and vegetables daily, or engaged in 0-29 min of physical activity weekly were less likely to attempt weight loss. CONCLUSIONS: Receiving advice on weight loss from health care providers to improve awareness of overweight and obesity status may be important factors for a person's weight management. Provider discussions about weight may be a strategy to motivate weight loss attempts.

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.

Evaluating Lung Cancer Screening Across Diverse Healthcare Systems: A Process Model from the Lung PROSPR Consortium.

Numerous organizations, including the United States Preventive Services Task Force, recommend annual lung cancer screening (LCS) with low-dose CT for high risk adults who meet specific criteria. Despite recommendations and national coverage for screening eligible adults through the Centers for Medicare and Medicaid Services, LCS uptake in the United States remains low (<4%). In recognition of the need to improve and understand LCS across the population, as part of the larger Population-based Research to Optimize the Screening PRocess (PROSPR) consortium, the NCI (Bethesda, MD) funded the Lung PROSPR Research Consortium consisting of five diverse healthcare systems in Colorado, Hawaii, Michigan, Pennsylvania, and Wisconsin. Using various methods and data sources, the center aims to examine utilization and outcomes of LCS across diverse populations, and assess how variations in the implementation of LCS programs shape outcomes across the screening process. This commentary presents the PROSPR LCS process model, which outlines the interrelated steps needed to complete the screening process from risk assessment to treatment. In addition to guiding planned projects within the Lung PROSPR Research Consortium, this model provides insights on the complex steps needed to implement, evaluate, and improve LCS outcomes in community practice.

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.

Perceptions of middle school educators in Hawai'i about school-based gardening and child health.

BACKGROUND: Childhood obesity prevention is a national priority. School-based gardening has been proposed as an innovative obesity prevention intervention. Little is known about the perceptions of educators about school-based gardening for child health. As the success of a school-based intervention depends on the support of educators, we investigated perceptions of educators about the benefits of gardening programs to child health. METHODS: Semi-structured interviews of 9 middle school educators at a school with a garden program in rural Hawai'i were conducted. Data were analyzed using a grounded theory approach. RESULTS: Perceived benefits of school-based gardening included improving children's diet, engaging children in physical activity, creating a link to local tradition, mitigating hunger, and improving social skills. Poverty was cited as a barrier to adoption of healthy eating habits. Opinions about obesity were contradictory; obesity was considered both a health risk, as well as a cultural standard of beauty and strength. Few respondents framed benefits of gardening in terms of health. CONCLUSIONS: In order to be effective at obesity prevention, school-based gardening programs in Hawai'i should be framed as improving diet, addressing hunger, and teaching local tradition. Explicit messages about obesity prevention are likely to alienate the population, as these are in conflict with local standards of beauty. Health researchers and advocates need to further inform educators regarding the potential connections between gardening and health.

Effects of a 2-year randomized soy intervention on sex hormone levels in premenopausal women.

OBJECTIVE: Several epidemiologic studies have described protective effects of soy consumption against breast cancer. The goal of this trial among premenopausal women was to examine the effect of soy foods on menstrual cycle length and circulating sex hormone levels. METHODS: This 2-year dietary intervention randomized 220 healthy premenopausal women. The intervention group consumed two daily servings of soy foods containing approximately 50 mg of isoflavones; the control group maintained their regular diet. Five blood samples (obtained in months 0, 3, 6, 12, and 24) were taken 5 days after ovulation as determined by an ovulation kit. The serum samples were analyzed for estrone, estradiol, sex hormone binding globulin, androstenedione, and progesterone by immunoassay. RESULTS: At baseline, both groups had similar demographic, anthropometric, and nutritional characteristics. The dropout rates of 15.6% (17 of 109) in the intervention group and 12.6% (14 of 111) in the control group did not differ significantly. According to soy intake logs, 24-hour recalls, and urinary isoflavone excretion, the women closely adhered to the study regimen. Menstrual cycles became slightly shorter in both groups but did not differ by group. Mixed general linear models indicated no significant intervention effect on any of the serum hormones. However, androstenedione and progesterone decreased significantly over time in both groups. CONCLUSIONS: The results of this study suggest that the preventive effects of soy on breast cancer risk in premenopausal women may not be mediated by circulating sex hormone levels. Different mechanisms of actions or effects of exposure earlier in life are alternate hypotheses that require further investigation.

Validation of a soy questionnaire with repeated dietary recalls and urinary isoflavone assessments over one year.

This study assessed the validity and reliability of a 12-item soy questionnaire designed for use in cancer prevention research. The questionnaire measures soy intake over the past year. Subjects were 199 healthy 35- to 46-yr-old premenopausal women participating in an ongoing soy intervention study. Soy questionnaire estimates of isoflavone intake over 1 yr were compared with individual and combined estimates from two reference measures covering the same period: three or four repeated 24-h recalls and one or two repeated urine analyses. The sensitivity and specificity of the soy questionnaire in classifying high vs. low exposure (high exposure = soy intervention group membership) were comparable with 24-h recalls and were superior to urine analyses (sensitivity = 94.8%, 97.9%, and 71.1%; specificity = 95.1%, 97.1%, and 90.3% for the soy questionnaire, 24-h recalls, and urine analyses, respectively). Soy questionnaire isoflavone estimates were highly correlated with the combination of the two reference measures for the entire study population. Its brevity, ease of administration, and good measurement properties over a 1-yr period make the soy questionnaire well suited to the needs of researchers who wish to identify high and low consumers of soy foods, especially in populations who consume traditional Asian soy foods.