Evaluation of Medicare's Intensive Behavioral Therapy for Obesity: the BieneStar Experience.

INTRODUCTION: In 2011, the Centers for Medicare and Medicaid Services began to reimburse primary care providers for intensive behavior therapy for obesity. This study evaluated a Centers for Medicare and Medicaid Services intensive behavior therapy for obesity program as implemented in primary care clinics. METHODS: Data for this retrospective cohort study were obtained between May 2012 and February 2015 and statistical analysis was performed in 2017. The sample included 643 participants who attended at least one BieneStar intensive behavior therapy for obesity program session. The primary outcome was weight, and covariates were number of sessions, age, race/ethnicity, diagnosis of hypertension and diabetes, and type of health insurance. RESULTS: Of 643 participants that initiated the BieneStar program, 641 had complete data. The median reduction in weight of participants was as follows: those who attended fewer than four sessions, 0 kg (95% CI=0, 0.11 kg); between four and eight sessions, 1.1 kg (95% CI=0.86, 1.59 kg); and more than eight sessions 3.7 kg (95% CI=3.36, 4.55 kg). Medians of weight were significantly different between each classification of session numbers (p<0.01). Participants lost on average 0.102 kg of weight per session attended. CONCLUSIONS: The BieneStar program showed that the weight of participants decreased as they attended more sessions. Further studies are needed to determine if these results can be reproduced in other office-based primary care clinics and the program's impact on chronic disease.

Reducing Cardiovascular Disparities Through Community-Engaged Implementation Research: A National Heart, Lung, and Blood Institute Workshop Report.

Cardiovascular disparities remain pervasive in the United States. Unequal disease burden is evident among population groups based on sex, race, ethnicity, socioeconomic status, educational attainment, nativity, or geography. Despite the significant declines in cardiovascular disease mortality rates in all demographic groups during the last 50 years, large disparities remain by sex, race, ethnicity, and geography. Recent data from modeling studies, linked micromap plots, and small-area analyses also demonstrate prominent variation in cardiovascular disease mortality rates across states and counties, with an especially high disease burden in the southeastern United States and Appalachia. Despite these continued disparities, few large-scale intervention studies have been conducted in these high-burden populations to examine the feasibility of reducing or eliminating cardiovascular disparities. To address this challenge, on June 22 and 23, 2017, the National Heart, Lung, and Blood Institute convened experts from a broad range of biomedical, behavioral, environmental, implementation, and social science backgrounds to summarize the current state of knowledge of cardiovascular disease disparities and propose intervention strategies aligned with the National Heart, Lung, and Blood Institute mission. This report presents the themes, challenges, opportunities, available resources, and recommended actions discussed at the workshop.

Embedding clinical interventions into observational studies.

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed.

Outcome of a food observational study among low-income preschool children participating in a family-style meal setting.

INTRODUCTION: In the United States, one out of every seven low-income children between the ages of 2 and 5 years is at risk for overweight and obesity. Formative research was conducted to determine if preschool children participating in family-style meals consumed the minimum food servings according to U.S. Department of Agriculture dietary guidelines. METHOD: Participants were 135 low-income children aged 3 to 4 years who attended an urban child care center. Participant's parents completed a Family Demographic Questionnaire to provide information on race/ethnicity, parent's level of education, and household income. Direct observation of children's food and beverage consumption during school breakfast and lunch was collected over 3 consecutive days. Dietary data were assessed using the Nutrition Data System for Research software. Height and weight measurements were obtained to determine risk for obesity. Descriptive statistics were reported by using the Statistical Package for the Social Sciences Version 16. RESULTS: Among 135 participants, 98% identified as Mexican American, 75% lived at or below poverty level, and 24% reported a family history of diabetes. Children consumed less than half of the calories provided between breakfast and lunch and did not consume the minimum recommended dietary food servings. Despite the poor dietary intake, physical measurement findings showed 25% obesity prevalence among study participants. CONCLUSIONS: Findings support the need for evidenced-based early childhood obesity prevention programs that provide behavior change opportunities for children, their families, teachers, and menu planners. Family-style meal settings are ideal opportunities for implementing nutrition education strategies to prevent early childhood obesity.

Cardiometabolic risk assessments by body mass index z-score or waist-to-height ratio in a multiethnic sample of sixth-graders.

Convention defines pediatric adiposity by the body mass index z-score (BMIz) referenced to normative growth charts. Waist-to-height ratio (WHtR) does not depend on sex-and-age references. In the HEALTHY Study enrollment sample, we compared BMIz with WHtR for ability to identify adverse cardiometabolic risk. Among 5,482 sixth-grade students from 42 middle schools, we estimated explanatory variations (R (2)) and standardized beta coefficients of BMIz or WHtR for cardiometabolic risk factors: insulin resistance (HOMA-IR), lipids, blood pressures, and glucose. For each risk outcome variable, we prepared adjusted regression models for four subpopulations stratified by sex and high versus lower fatness. For HOMA-IR, R (2) attributed to BMIz or WHtR was 19%-28% among high-fatness and 8%-13% among lower-fatness students. R (2) for lipid variables was 4%-9% among high-fatness and 2%-7% among lower-fatness students. In the lower-fatness subpopulations, the standardized coefficients for total cholesterol/HDL cholesterol and triglycerides tended to be weaker for BMIz (0.13-0.20) than for WHtR (0.17-0.28). Among high-fatness students, BMIz and WHtR correlated with blood pressures for Hispanics and whites, but not black boys (systolic) or girls (systolic and diastolic). In 11-12 year olds, assessments by WHtR can provide cardiometabolic risk estimates similar to conventional BMIz without requiring reference to a normative growth chart.

Impact of implementation and conduct of the HEALTHY primary prevention trial on student performance.

PURPOSE: To determine whether a school-wide intervention program to reduce risk factors for type 2 diabetes (T2D) affected student achievement, rates of disciplinary actions, and attendance rates. DESIGN: The HEALTHY primary prevention trial was designed to evaluate a comprehensive school-based intervention to reduce factors for T2D, especially overweight and obesity. Students were followed up from beginning of sixth grade (Fall 2006) through end of eighth grade (Spring 2009). SETTING: Forty-two middle schools at seven U.S. sites. SUBJECTS: Schools were randomized in equal numbers at each site to intervention (21 schools, 2307 students) or control (21 schools, 2296 students). Intervention . An integrated school-wide program that focused on (1) foods and beverages, (2) physical education, (3) classroom-based behavior change and education, and (4) social marketing communication and promotional campaigns. MEASURES: Aggregate (grade- and school-wide) test performance (passing rate), attendance, and referrals for disciplinary actions. ANALYSIS: Descriptive statistics and tests of intervention versus control using mixed linear models methods to adjust for the clustering of students within schools. RESULTS: There were no differences between intervention and control schools in test performance for mathematics (p = .7835) or reading (p = .6387), attendance (p = .5819), or referrals for disciplinary action (p = .8671). CONCLUSION: The comprehensive HEALTHY intervention and associated research procedures did not negatively impact student achievement test scores, attendance, or referrals for disciplinary action.

Association between frequency of ready-to-eat cereal consumption, nutrient intakes, and body mass index in fourth- to sixth-grade low-income minority children.

BACKGROUND: The consumption of non-ready-to-eat cereal and ready-to-eat cereal (RTEC) breakfasts have been associated with increased nutrient intakes and lower body mass index (BMI). These relationships have not been examined in low-income minority children. OBJECTIVES: To evaluate, in low-income minority children, whether there is a relationship among the frequency of RTEC consumption and nutrient intakes measured at baseline, and whether there is a relationship between the frequency of RTEC and BMI controlling for age, sex, ethnicity, and energy intake. DESIGN: A longitudinal study design where a cohort was followed for 3 years. SUBJECTS/SETTING: Participants were 625 fourth- through sixth-grade, low-income children living in San Antonio, Texas, and enrolled in the control arm of the Bienestar Diabetes Prevention Program's cluster randomized trial. Three multiple-pass 24-hour dietary recalls were collected at the beginning of their fourth-grade year and at the end of their fifth- and sixth-grade years. Children's age, sex, ethnicity, and height and weight (used to calculate BMI) were collected between August 2001 and May 2004. STATISTICAL ANALYSES PERFORMED: Descriptive and inferential statistical analyses were performed. The frequency of breakfast consumption was examined using a 6×4 cross-tabulation table with χ(2) test to establish categorical differences. The degree of association between BMI percentile and frequency of RTEC consumption adjusted for age, sex, ethnicity, and nutrition-related parameters were calculated using a partial correlation multivariate linear model analysis. RESULTS: There was a significant positive relationship between the frequency of RTEC consumption and nutrient intakes measured at baseline. There was also a significant inverse relationship between frequency of RTEC consumption and BMI percentile over the cumulative 3-year period controlling for age, sex, ethnicity, and energy intake. CONCLUSIONS: Children who frequently consumed RTEC had greater intakes of essential nutrients at baseline and significantly lower BMI over a 3-year period.

HEALTHY study school food service revenue and expense report.

BACKGROUND: Food service directors have a concern that federal reimbursement is not meeting the demands of increasing costs of healthier meals. The purpose of this article is to report the food option changes and the annual revenues and expenses of the school food service environment. METHODS: The HEALTHY study was a 3-year (2006 to 2009) randomized, cluster-designed trial conducted in 42 middle schools at 7 field centers. The schools selected had at least 50% of students who were eligible for free or reduced-price lunch or who belonged to a minority group. A randomly assigned half of the HEALTHY schools received a school health intervention program consisting of 4 integrated components: nutrition, physical activity, behavioral knowledge and skills, and social marketing. The nutrition component consisted of changing the meal plans to meet 5 nutrition goals. Revenue and expense data were collected from income statements, federal meal records, à la carte sale sheets, school store sale sheets, donated money/food records, and vending machines. RESULTS: Although more intervention schools reached the nutritional goals than control schools, revenues and expenses were not significantly different between groups. CONCLUSION: The HEALTHY study showed no adverse effect of school food policies on food service finances.

Improving quality of Food Frequency Questionnaire response in low-income Mexican American children.

The authors evaluated the validity and reliability of the Block Kids Food Frequency Questionnaire (BKFFQ) and the Block Kid Screener (BKScreener) in Mexican American children living along the Texas-Mexico border who participated in the National Institutes of Health-funded Proyecto Bienestar Laredo. The Bienestar/NEEMA health program is a school-based diabetes and obesity control program, and the Proyecto Bienestar Laredo is the translation of the Bienestar/NEEMA health program to 38 elementary schools in Laredo, Texas. Par ticipants included 2,376 eight-year-old boys (48%) and girls (52%) from two school districts in Laredo. Two Food Frequency Questionnaire (BKFFQ and BKScreener) dietary intakes were collected, and an expert panel of nutritionist assigned a classification response quality of "Good," "Questionable," and "Poor," based on playfulness (systematic or nonrandom) patterns and completion rates. In addition, both instruments were assessed for reliability (test-retest) in 138 students from a San Antonio School District. Children's height, weight, percentage body fat, reported family history of diabetes, and Texas Assessments of Knowledge and Skills in reading and mathematics scores were collected. This study showed that for Mexican American children living along the Texas-Mexico border, within the time constraints of the classroom, BKScreener yielded better data than the BKFFQ.

A school-based intervention for diabetes risk reduction.

BACKGROUND: We examined the effects of a multicomponent, school-based program addressing risk factors for diabetes among children whose race or ethnic group and socioeconomic status placed them at high risk for obesity and type 2 diabetes. METHODS: Using a cluster design, we randomly assigned 42 schools to either a multicomponent school-based intervention (21 schools) or assessment only (control, 21 schools). A total of 4603 students participated (mean [+/- SD] age, 11.3 [+/- 0.6 years; 54.2% Hispanic and 18.0% black; 52.7% girls). At the beginning of 6th grade and the end of 8th grade, students underwent measurements of body-mass index (BMI), waist circumference, and fasting glucose and insulin levels. RESULTS: There was a decrease in the primary outcome--the combined prevalence of overweight and obesity--in both the intervention and control schools, with no significant difference between the school groups. The intervention schools had greater reductions in the secondary outcomes of BMI z score, percentage of students with waist circumference at or above the 90th percentile, fasting insulin levels (P=0.04 for all comparisons), and prevalence of obesity (P=0.05). Similar findings were observed among students who were at or above the 85th percentile for BMI at baseline. Less than 3% of the students who were screened had an adverse event; the proportions were nearly equivalent in the intervention and control schools. CONCLUSIONS: Our comprehensive school-based program did not result in greater decreases in the combined prevalence of overweight and obesity than those that occurred in control schools. However, the intervention did result in significantly greater reductions in various indexes of adiposity. These changes may reduce the risk of childhood-onset type 2 diabetes. (Funded by the National Institutes of Health and the American Diabetes Association; ClinicalTrials.gov number, NCT00458029.)

Accuracy of self-reported energy intakes in low-income urban 4th grade minority children.

We examined the accuracy of self-reported energy intake (rEI) in low-income, urban minority school-aged children at risk for obesity and associated diabetes utilizing a relatively new, simple previously published prediction equation for identifying inaccurate reports of dietary energy intake. Participants included 614 nine-year-old boys (51%) and girls (49%). Three 24-h dietary recalls were collected. Children's height, weight (used to calculate BMI), and percent body fat (%BF) were measured. Physical fitness, reported family history of diabetes, and ethnicity were also collected. A previously published prediction equation was used to determine the validity of rEIs in these children to identify under-, plausible-, and over-reporters. Additionally, we examined the question of whether there is a difference in reporting by sex, ethnicity, BMI, and %BF. On average, 18% of the children were at risk of being overweight, 43% were already overweight at baseline, yet these children reported consuming fewer calories on average than recommended guidelines. Additionally, reported caloric intake in this cohort was negatively associated with BMI and %BF. Using the previously described methods, 49% of participants were identified as under-reporters, whereas 39 and 12% were identified as plausible- and over-reporters, respectively. On average, children reported caloric intakes that were almost 100% of predicted energy requirement (pER) when the sedentary category was assigned. Inactivity and excessive energy intake are important contributors to obesity. With the rising rates of obesity and diabetes in children, accurate measures of energy intake are needed for better understanding of the relationship between energy intake and health outcomes.

Identifying barriers that hinder onsite parental involvement in a school-based health promotion program.

We investigated whether barriers to onsite parental involvement in the Bienestar Health Program Parent Component could be identified and whether participation rates could be increased by addressing these barriers. All nonparticipating parents of fourth-grade students of San Antonio Independent School District from 4 schools, which were selected randomly from 20 intervention schools in Bienestar, were invited to take part in this study. A total of 47 of 223 (21%) parents engaged in one of four focus groups offered. Parents identified barriers to their involvement in Bienestar that fit into five descriptive categories: (a) low value, (b) high cost, (c) competing family demands, (d) concerns about the program design, and (e) social role norms. The Bienestar Parent Component was then modified according to the focus group findings, which resulted in a marked increase in parental involvement from 17% to 37% overall. These findings suggest that even when parents are involved in the initial design of parent-friendly and culturally sensitive programs, as was the case for Bienestar, maximizing parental involvement may require additional assessment, identification, and remediation of barriers.

Risk factors for type 2 diabetes in a sixth- grade multiracial cohort: the HEALTHY study.

OBJECTIVE: HEALTHY is a 3-year middle school intervention program designed to reduce risk factors for type 2 diabetes. The prevalence of diabetes risk factors at baseline in a cohort of 6,358 sixth-grade students is reported. RESEARCH DESIGN AND METHODS: Forty-two schools at seven U.S. sites were randomly assigned to intervention or control. Students participated in baseline data collection during fall of 2006. RESULTS: Overall, 49.3% of children had BMI >or=85th percentile, 16.0% had fasting blood glucose >or=100 mg/dl (<1% had fasting blood glucose >or=126 mg/dl), and 6.8% had fasting insulin >or=30 microU/ml. Hispanic youth were more likely to have BMI, glucose, and insulin levels above these thresholds than blacks and whites. CONCLUSIONS: Sixth-grade students in schools with large minority populations have high levels of risk factors for type 2 diabetes. The HEALTHY intervention was designed to modify these risk factors to reduce diabetes incidence.

Diabetes risk, low fitness, and energy insufficiency levels among children from poor families.

BACKGROUND: Low-income populations have higher rates of type 2 diabetes and it is the hope of the investigators to increase support for the dissemination of evidence-based prevention programs aimed at children from poor families. OBJECTIVE: To determine the prevalence of high blood glucose, obesity, low fitness, and energy insufficiency levels among children from poor families. DESIGN: The cross-sectional study conducted in fall 2001 used fasting capillary glucose, body mass index, body fat, step test, and three 24-hour dietary recalls to assess diabetes risk factor levels. SUBJECTS: Participants were 1,402 fourth-grade students aged 8 to 10 years. The racial/ethnic backgrounds were 80% Mexican American, 10% African American, 5% Asian American, and 5% non-Hispanic white. STATISTICAL ANALYSIS PERFORMED: All data were analyzed for descriptive statistics and frequencies of distribution. Means were computed by sex for all diabetes risk factors and t test conducted to determine differences between sexes. RESULTS: Nearly 75% of participants lived in households with

Validation of the Physical Activity Questionnaire for Older Children in children of different races.

The Physical Activity Questionnaire for Older Children (PAQ-C) is a validated self-report measure of physical activity widely used to assess physical activity in children (8-14 years of age). To date, however, the instrument has been validated in largely White Canadian samples. The purpose of the present article is to determine the psychometric properties of the PAQ-C for African American, European American, and Hispanic children. Two studies were conducted in which independent samples were administered the PAQ-C, along with varying indices of cardiovascular fitness, fatness, and psychological measures related to physical activity. Results showed that the reliability and validity of the PAQ-C varied by race and that modifications might be necessary.

NEEMA: a school-based diabetes risk prevention program designed for African-American children.

OBJECTIVE: To conduct formative assessment and preliminary biological impact of a school-based diabetes risk prevention program for African-American children during a 14-week study. METHODS: NEEMA is a school-based diabetes prevention program tailored for African-American children. The NEEMA is implemented via four social networks-classroom (Health and Physical Education Class), after school (Health Club), home (Family Fun Fair) and school cafeteria (Food Service Program). Formative assessment data were collected through semistructured interviews with physical education (PE) teachers and a pre-to-post design was used to measure biological impact. Fasting capillary glucose, height, weight, body mass index, percent body fat and fitness data were collected from a sample of 58 fourth-grade students. The six elementary schools had > 40% African-American enrollment and were located in low-income neighborhoods. RESULTS: Face-to-face interview data revealed diabetes, obesity and food insufficiency as major health concerns among PE teachers. Teachers also cited large classes and short PE periods as major challenges for implementing the program. From baseline to follow-up, fitness laps increased from 16.40 (SD = 9.98) to 23.72 (SD = 14.79) (p < 0.000), fasting capillary glucose decreased from 89.17 mg/dl (SD = 10.05) to 83.50 mg/dl (SD = 11.26) (p < 0.000), and percent body fat decreased from 27.26 (SD=12.89) to 26.68 (SD = 11.67) (p < 0.537). CONCLUSION: The NEEMA pilot study provided teacher feedback useful for revising the NEEMA health curricula and positive preliminary impact of the NEEMA PE class on children's fitness and blood glucose levels.

Impact of the Bienestar school-based diabetes mellitus prevention program on fasting capillary glucose levels: a randomized controlled trial.

OBJECTIVE: To evaluate the impact of a school-based diabetes mellitus prevention program on low-income fourth-grade Mexican American children. DESIGN: A randomized controlled trial with 13 intervention and 14 control schools. SETTING: Elementary schools in inner-city neighborhoods in San Antonio, Tex. PARTICIPANTS: Eighty percent of participants were Mexican American and 94% were from economically disadvantaged households. Baseline and follow-up measures were collected from 1419 (713 intervention and 706 control) and 1221 (619 intervention and 602 control) fourth-grade children, respectively. INTERVENTION: The Bienestar Health Program consists of a health class and physical education curriculum, a family program, a school cafeteria program, and an after-school health club. The objectives are to decrease dietary saturated fat intake, increase dietary fiber intake, and increase physical activity. MAIN OUTCOME MEASURES: The primary end point was fasting capillary glucose level, and the secondary end points were percentage of body fat, physical fitness level, dietary fiber intake, and dietary saturated fat intake. Fasting capillary glucose level, bioelectric impedance, modified Harvard step test, three 24-hour dietary recalls, weight, and height were collected at baseline and 8 months later. RESULTS: Children in the intervention arm attended an average of 32 Bienestar sessions. Mean fasting capillary glucose levels decreased in intervention schools and increased in control schools after adjusting for covariates (-2.24 mg/dL [0.12 mmol/L]; 95% confidence interval, -6.53 to 2.05 [-0.36 to 0.11 mmol/L]; P =.03). Fitness scores (P =.04) and dietary fiber intake (P =.009) significantly increased in intervention children and decreased in control children. Percentage of body fat (P =.56) and dietary saturated fat intake (P =.52) did not differ significantly between intervention and control children. CONCLUSION: This intervention showed some positive results, but additional research is needed to examine long-term benefits, translation, and cost-effectiveness.