Impact of school-based vegetable garden and physical activity coordinated health interventions on weight status and weight-related behaviors of ethnically diverse, low-income students: Study design and baseline data of the Texas, Grow! Eat! Go! (TGEG) cluster-randomized controlled trial.

BACKGROUND: Coordinated, multi-component school-based interventions can improve health behaviors in children, as well as parents, and impact the weight status of students. By leveraging a unique collaboration between Texas AgriLife Extension (a federal, state and county funded educational outreach organization) and the University of Texas School of Public Health, the Texas Grow! Eat! Go! Study (TGEG) modeled the effectiveness of utilizing existing programs and volunteer infrastructure to disseminate an enhanced Coordinated School Health program. The five-year TGEG study was developed to assess the independent and combined impact of gardening, nutrition and physical activity intervention(s) on the prevalence of healthy eating, physical activity and weight status among low-income elementary students. The purpose of this paper is to report on study design, baseline characteristics, intervention approaches, data collection and baseline data. METHODS: The study design for the TGEG study consisted of a factorial group randomized controlled trial (RCT) in which 28 schools were randomly assigned to one of 4 treatment groups: (1) Coordinated Approach to Child Health (CATCH) only (Comparison), (2) CATCH plus school garden intervention [Learn, Grow, Eat & Go! (LGEG)], (3) CATCH plus physical activity intervention [Walk Across Texas (WAT)], and (4) CATCH plus LGEG plus WAT (Combined). The outcome variables include student's weight status, vegetable and sugar sweetened beverage consumption, physical activity, and sedentary behavior. Parents were assessed for home environmental variables including availability of certain foods, social support of student health behaviors, parent engagement and behavior modeling. RESULTS: Descriptive data are presented for students (n = 1369) and parents (n = 1206) at baseline. The sample consisted primarily of Hispanic and African American (53 % and 18 %, respectively) and low-income (i.e., 78 % eligible for Free and Reduced Price School Meals program and 43 % food insecure) students. On average, students did not meet national guidelines for vegetable consumption or physical activity. At baseline, no statistical differences for demographic or key outcome variables among the 4 treatment groups were observed. CONCLUSIONS: The TGEG study targets a population of students and parents at high risk of obesity and related chronic conditions, utilizing a novel and collaborative approach to program formulation and delivery, and a rigorous, randomized study design.

Validity and Reliability of an Expanded Vegetable Questionnaire Among Elementary School Children.

BACKGROUND: The purpose of this study was to expand the School Physical Activity and Nutrition questionnaire to include a greater variety of vegetables and to evaluate the relative validity and reliability of these revised items. OBJECTIVES: This study utilized 2 convenience samples of third to fifth graders for an analysis: validity (n = 70) and reliability (n = 76). Validity was assessed by comparing questionnaire items with vegetable intake reported from a 24-hour dietary recall covering the same reference period. Reliability estimates were assessed via same-day test-retest. RESULTS: Agreement correlations ranged from 0.35 to 0.71. Kappa statistics varied from 0.16 to 0.66. Percentage agreements ranged from 57% to 87%. Test-retest Spearman coefficients were greater than 0.50 for 6 items, weighted Kappa values were greater than 0.40 for all 7 items, and percentage agreement exceeded 75% for 5 items. CONCLUSIONS: Results suggest that the questionnaire is a valid and reliable measure of the previous day's vegetable intake in third- to fifth-grade students. This trial was registered at ClinicalTrials.gov as NCT02668744.

A phase I study of CR002, a fully-human monoclonal antibody against platelet-derived growth factor-D.

OBJECTIVE: To investigate the safety, pharmacokinetics (PK), binding activity and immunogenicity of CR002, a human monoclonal antibody (mAb) directed against platelet-derived growth factor-D (PDGF-D), administered as a single intravenous (i.v.) infusion over a range of doses. SUBJECTS: 40 healthy male subjects received increasing doses of CR002 at 0.3, 1, 3, 10, 30 mg/kg or placebo. METHOD: This was a randomized, double-blind, placebo-controlled, dose-escalation Phase I study. The trial had a duration of 90 days, with dosing on Day 1 and follow-up visits on Days 2, 4, 7, 14, 21, 30, 45 and 90. Serum was collected for PK, binding activity and immunogenicity analysis at screening and up to Day 90. Safety was recorded throughout the study by performing laboratory tests, recording vital signs and electrocardiograms (ECGs), by monitoring the occurrence of adverse events (AEs). The use of concomitant medications was also recorded. RESULTS: All 40 subjects received CR002 or placebo, and completed the trial. No dose-limiting toxicities (DLTs) occurred, the maximum tolerated dose (MTD) was not reached and was estimated as > 30 mg/kg. There were no deaths during this study and no SAEs or other significant AEs reported. The most frequent drug-related treatment-emergent AE (TEAE) was headache in 4 of 30 subjects (13.3%) in the CR002 group vs. 0 of 10 subjects in the placebo group. CR002 exhibited linear PK parameters, had a long half-life (t1/2 in the range 15.5 â 48.1 days) and a volume of distribution at steady state in the range 4.7 â 6.5. Free PDGF-D in the serum bound to CR002 in a reversible manner, as shown in the lowest dose cohort. However, levels of total circulating PDGF-D remained constant throughout the study. There were no anti-CR002 antibodies detected in subjects dosed with CR002. CONCLUSIONS: CR002 was safe and well-tolerated at all doses tested as a single i.v. administration. The MTD was estimated to be above 30 mg/kg, the highest dose tested. CR002 had a long half-life, low clearance and a limited tissue distribution. Although total levels of PDGF-D at all dose levels remained relatively constant, there was no detectable circulating free PDGF-D after CR002 administration. At the lowest CR002 dose tested (0.3 mg/kg), PDGF-D was detectable again by Day 21 and the levels increased near to pre-infusion levels by Day 90. In this study, CR002 was not immunogenic during the 90-day study period.

Dietary Intake, Attitudes toward Healthy Food, and Dental Pain in Low-Income Youth.

Few studies have examined the relation between food consumption and related attitudes and dental pain among children. The objective of this study is to examine the associations of healthy and unhealthy food items, attitudes toward healthy food, and self-efficacy of eating healthy with dental pain among children. A cross-sectional analysis was performed using child survey data from the Texas Childhood Obesity Research Demonstration (TX CORD) project. Fifth-grade students ( n = 1,020) attending 33 elementary schools in Austin and Houston, Texas, completed the TX CORD Child Survey, a reliable and valid survey instrument focused on nutrition and physical activity behaviors. All nutrition questions ask about the number of times food and beverage items were consumed on the previous day. Dental pain was reported as mouth or tooth pain in the past 2 wk that made their mouth hurt so much that they could not sleep at night. Mixed-effects logistic regression models were used to test the association between 10 unhealthy food items, 9 healthy food items, 2 health attitudes, and self-efficacy with dental pain. All models controlled for sociodemographic variables. In total, 99 (9.7%) students reported dental pain. Dental pain was associated with intake of the following unhealthy items: soda, fruit juice, diet soda, frozen desserts, sweet rolls, candy, white rice/pasta, starchy vegetables, French fries/chips, and cereal (adjusted odds ratio [AOR], 1.27-1.81, P < 0.01). The intake of other vegetables (AOR, 1.56; P < 0.01), a healthy item, and the attitude that healthy food tastes good (AOR, 1.59; P = 0.04) were also positively associated with dental pain. The attitude of eating healthier leads to fewer health problems (AOR, 0.50) and self-efficacy for healthy eating (AOR, 0.44) were negatively associated with dental pain ( P < 0.01). Interventions should focus on improving oral health by reducing intake of unhealthy foods and educating children and families on the importance of diet as a means of reducing dental caries. Knowledge Transfer Statement: The results of this study can be used to inform researchers on potential food items and psychosocial measures to examine in low-income, minority populations for longitudinal research. These results would also be useful to educators who could incorporate oral health care and nutrition education into school curriculums.

The associations of large-for-gestational-age and infant feeding practices with children's body mass index z-score trajectories: the Early Childhood Longitudinal Study, Birth Cohort.

Very few studies have examined if high birth weight and infant feeding practices have implications for the trajectory of body mass index (BMI) growth across the early childhood period. The goal of this study was to assess if large-for-gestational-age (LGA) and infant feeding practices (exclusive breastfeeding for 6 months, and early introduction of complementary food prior to 4 months) are associated with BMI z-score trajectories over the early childhood period. Group-based trajectory modelling (GBTM) methods were employed to describe and classify developmental BMI z-score trajectories (the outcome of interest) in children from 9 months to 4 years of age (n = 4497) born to prenatal non-smoking mothers in the Early Childhood Longitudinal Study, Birth Cohort (2001-2005). Further analyses examined if the identified BMI z-score trajectories varied systematically with the exposures, LGA and specific infant feeding practices, after accounting for sociodemographic and other early-life factors. Two BMI z-score trajectory groups were identified: normal BMI z-score (56.2%) and high BMI z-score (43.8%). Children who were LGA infants had 2.3 times (risk ratio 95% confidence interval: 1.2, 4.5) greater risk of being in high BMI z-score group relative to normal BMI z-score group. BMI z-score trajectory groups did not differ by infant feeding practices, after controlling for LGA at birth. Membership in the high BMI z-score group was associated with LGA, but not with infant feeding practices. Healthcare professionals should provide early obesity counselling to parents of LGA infants so that parents can take appropriate obesity prevention measures for their children.

How local and state regulations affect the child care food environment: A qualitative study of child care center directors' perspectives.

Almost one-third of preschoolers spend regular time in child care centers where they can consume the majority of their daily dietary intake. The child care setting influences children's dietary intake. Thus, it is important to examine factors, such as local and state regulations, that influence the food environment at the center. This qualitative study explored directors' perceptions of how regulations influence the foods available at child care centers. Ten directors of centers in Travis County, Texas completed semi-structured interviews. Directors reported that changes in local health department regulations (e.g., kitchen specifications) result in less-healthful foods being served (e.g., more prepackaged foods). Directors of centers that do not participate in the federal Child and Adult Care Food Program (CACFP) said the state licensing regulations clarify the portion size and nutritional requirements for preschoolers thereby improving the nutritional quality of the food served. Directors of centers participating in CACFP said they are not affected by state mandates, because the CACFP regulations are more stringent. These findings suggest that state regulations that specify and quantify nutritional standards may beneficially impact preschoolers' diets. However, local health department regulations enacted to improve food safety may negatively influence the nutritional value of food served in centers.

Hypertension in diabetic patients: an update of interventional studies to preserve renal function.

Hypertension and diabetes mellitus are a malignant combination of diseases for the kidney. They markedly increase the risk for progressive renal injury and are the largest single cause of renal failure. Strategies to reduce the risk for renal injury in hypertensive diabetics are very important. Although Type I and Type II diabetes are different diseases, they may be associated with similar mechanisms of renal injury in hypertensive patients. Reduction of elevated systemic arterial pressure is of proven benefit in limiting progressive renal injury in diabetic hypertensives. However, converting enzyme inhibitors and possibly the nondihydropyridine calcium antagonists may possess antiproteinuric abilities independent of blood pressure reduction which, in addition to their antihypertensive effects, may be important in limiting the progression of human diabetic renal disease. Long-term clinical trials have evaluated the impact of these and other agents on progression of diabetic renal disease. This paper reviews these trials and focuses on renal effects of antihypertensive agents independent of blood pressure reduction.

Do adolescent vitamin-mineral supplement users have better nutrient intakes than nonusers? Observations from the CATCH tracking study.

OBJECTIVE: Describe whether users of vitamin-mineral supplements differed from nonusers in micronutrient intakes or in nutrition awareness. DESIGN: Cross-sectional, observational study. SUBJECTS: One thousand five hundred thirty-two students now in grade 8, who participated in the Third Child and Adolescent Trial for Cardiovascular Health tracking study and who also provided a single 24-hour dietary recall. STATISTICAL ANALYSES PERFORMED: Mixed-model analysis of covariance was used to ascertain if supplement users had higher vitamin and mineral intakes from food sources, and to examine if supplement users had better nutrition awareness than nonusers. RESULTS: The 24-hour recall showed that 17.6% of the students reported using vitamin-mineral supplements. Users reported a mean of 1.4 supplements, of which 47% were multivitamin or multimineral preparations, 37% were single nutrients, and 16% were combinations. White persons and residents of Minnesota and California were more likely to be supplement users. Users had higher micronutrient intakes from food sources for 16 of the 20 nutrients studied after adjusting for gender, race/ethnicity, site, treatment condition, and within-school variability. Users had higher scores on a health behavior survey for food choice and slightly but not significantly higher nutrition knowledge scores. CONCLUSIONS: Vitamin-mineral supplement use is prevalent among eighth-grade students. Users have higher nutrient intakes from foods, higher total intakes for several micronutrients, higher nutrition awareness, and differ in their demographic characteristics from nonusers.

Reliability and validity of the Child and Adolescent Trial for Cardiovascular Health (CATCH) Food Checklist: a self-report instrument to measure fat and sodium intake by middle school students.

OBJECTIVE: To develop a scoring algorithm and evaluate the reliability and validity of scores from the Child and Adolescent Trial for Cardiovascular Health (CATCH) Food Checklist (CFC) as measures of total fat, saturated fat, and sodium intake in middle school students. DESIGN: Randomized, controlled trial in which participants were assigned to 1 of 3 study protocols that varied the order of CFC and 24-hour dietary recall administration. Criterion outcomes were percent energy from total fat, percent energy from saturated fat, and sodium intake in milligrams. SUBJECTS/SETTING: A multiethnic sample (33% ethnic and racial minorities) of 365 seventh-grade students from 8 schools in 4 states. STATISTICAL ANALYSES: Multivariable regression models were used to calibrate the effects of individual food checklist items; bootstrap estimates were used for cross-validation; and kappa statistics, Pearson correlations, t tests, and effect sizes were employed to assess reliability and validity. RESULTS: The median same-day test-retest reliability kappa for the 40 individual CFC food items was 0.85. With respect to item validity, the median kappa statistic comparing student choices to those identified by staff dietitians was 0.54. Test-retest reliability coefficients ranged from 0.84 to 0.89 for CFC total nutrient scores. Correlations between CFC scores and 24-hour recall values were 0.36 for total fat, 0.36 for saturated fat, and 0.34 for sodium; CFC scores were consistent with hypothesized gender differences in nutrient intake. APPLICATIONS/CONCLUSIONS: The CFC is a reliable and valid tool for measuring fat, saturated fat, and sodium intake in middle school students. Its brevity and ease of administration make the CFC a cost-effective way to measure middle school students' previous day's intake of selected nutrients in school surveys and intervention studies.

The effect of three finishing systems on four esthetic restorative materials.

Previous studies have investigated the finishing and smoothness of composite and traditional glass-ionomer restorations, but few have included resin-modified glass-ionomer cements or more recent finishing systems. The results of using three different finishing systems (Sof-Lex, Enhance, finishing burs) on two composites (Silux, Prisma TPH), a traditional glass ionomer (Ketac-Fil), and a resin-modified glass ionomer (Fuji II LC) were studied. Sixty samples were condensed into sectioned acrylic tubes, covered with a Mylar matrix plus a glass slide at each surface, then cured as per the manufacturers' instructions. Samples were randomized to three groups of five for each material and testing with a Surfanalyzer 4000 of unfinished samples (cured with Mylar matrix) was done to obtain baseline average surface roughness (Ra). Samples were then finished as per the manufacturers' instructions using polishing disks, abrasive impregnated disks, and finishing burs before further surface testing. Samples finished with burs and with abrasive impregnated disks were further polished using polishing paste (Prisma Gloss) and again tested. Data were analyzed with ANOVA testing and Tukey's HSD pairwise comparison. Initial testing after randomization to groups showed no significant difference in surface roughness (P = 0.24). Two-factor analysis revealed no significant difference between materials (P = 0.34), a significant difference in method of finish (P < or = 0.00), with no significant interaction between type of material and method of finish (P = 0.11). Aluminum oxide disk and impregnated disk systems provided the best finish for microfilled composite and both glass-ionomer materials (P < or = 0.00). No significant difference in method of finish existed with the hybrid composite (P = 0.07). Overall, esthetic restorative material finishing is best accomplished using abrasive impregnated disks or aluminum oxide disks. Finishing burs gave a significantly rougher surface than the former methods.

Effect of light source position and bevel placement on facial margin adaptation of resin-based composite restorations.

PURPOSE: To evaluate the effect of direction of first cure and the presence or absence of a facial margin bevel on the adaptation of facial margins of Class III resin-based composite (RBC) restorations. MATERIALS AND METHODS: Custom polyvinyl siloxane (PVS) light shields were fabricated for both the mesial and distal surfaces of 20 extracted incisors. Class III cavities were prepared in the mesial and distal surfaces of the incisors. On the facial, lingual, and gingival margins of 20 of the preparations a 0.5 mm wide enamel bevel was placed. The lingual and gingival, but not the facial, margins were beveled on the other 20 preparations. The PVS light shield was adapted to the tooth and trimmed to allow 1-2 mm of the facial margin to be exposed on 10 of the beveled and 10 of the non-beveled preparations. For the remaining 20 preparations the PVS light shield was trimmed to allow access of the curing light only from the lingual. Teeth were restored with Prisma TPH RBC. Using the appropriate shield, restorations in the facial first cure group were cured first from the facial and then from the lingual. Restorations in the lingual first cure group were cured only from the lingual. Restorations were finished flush with enamel margins and thermocycled following storage. Samples were exposed to a 50% solution of silver nitrate followed by light exposure. Teeth were sectioned and microleakage was evaluated at three levels (incisal, middle, and cervical). Four evaluators (blinded to direction of cure) independently scored microleakage using a categorical evaluation scale. Statistical analysis included non-parametric descriptive statistics, Cohen's kappa, chi-square analysis, and Kruskal-Wallis ANOVA. RESULTS: Samples prepared without a facial bevel revealed significantly more (P = 0.01) microleakage than preparations with a facial bevel. At the most incisal level, restorations cured first from the facial revealed significantly more (P < 0.001) microleakage than restorations cured first from the lingual. At the middle and cervical levels, restorations cured first from the facial revealed significantly less (P < 0.001) microleakage than restorations cured first from the lingual. When a facial bevel was present, samples cured first from the facial showed significantly less (P < 0.001) microleakage than those cured only from the lingual.

The rationale for soft-tissue grafting and vestibuloplasty in association with endosseous implants: a literature review.

Significant soft-tissue complications have been reported around endosseous implant permucosal abutments. Peri-implantitis with associated bone loss can have a negative effect on the long-term prognosis of the implant reconstruction. The rationale for soft-tissue grafting and vestibuloplasty techniques is presented in the form of a literature review. The implant sulcular epithelium, permucosal seal, and the peri-implant connective tissues are discussed. The etiology of soft-tissue complications as well as the significance of attached gingiva surrounding implant abutments are presented along with techniques for surgical intervention.

The rationale for soft-tissue grafting and vestibuloplasty in association with endosseous implants: a literature review.

Significant soft-tissue complications have been reported around endosseous implant permucosal abutments. Peri-implants with associated bone loss can have a negative effect on the long-term prognosis of the implant reconstruction. The rationale for soft-tissue grafting and vestibuloplasty techniques is presented in the form of a literature review. The implant sulcular epithelium, permucosal seal, and the peri-implant connective tissues are discussed. The etiology of soft-tissue complications as well as the significance of attached gingiva surrounding implant abutments are presented along with techniques for surgical intervention.

Gene-environment interaction and the GNB3 gene in the Atherosclerosis Risk in Communities study.

OBJECTIVE: The purpose of this study was to investigate the interaction between the G-protein beta-3 (GNB3) 825C>T polymorphism and physical activity in relation to prevalent obesity and hypertension. RESEARCH METHODS AND PROCEDURES: The GNB3 825C>T genotype was measured in a sample of 14,716 African Americans (AAs) and whites from the Atherosclerosis Risk in Communities (ARIC) study, and logistic regression was used to test for genetic effects and gene-environment interactions. RESULTS: The GNB3 825C>T variant was not independently associated with prevalent obesity or hypertension in either AA or whites. However, we observed a significant interaction (P<0.001) between this variant and physical activity in predicting obesity status in AAs. In AAs who were active, each 825T allele was associated with a 20% lower prevalence of obesity (odds ratio (OR)=0.80, 95% confidence interval (CI)=0.689-0.937, P=0.005), whereas each 825T allele was associated with a 23% greater prevalence of obesity for low-active individuals (OR=1.23, 95% CI=1.06-1.44, P=0.008). We also found a significant interaction between the GNB3 825C>T polymorphism, obesity status and physical activity in predicting hypertension in the AA subjects. AA homozygotes for the 825T allele who were both obese and had a low activity level were 2.7 times more likely to be hypertensive, compared to non-obese, active 825C homozygotes (OR=2.71, 95% CI=1.19-6.17, P<0.02). DISCUSSION: Our findings suggest that the variation within the GNB3 gene may interact with physical activity level to influence obesity status and, together with obesity and physical activity, the GNB3 825C>T variant may influence hypertension prevalence in AAs.

Genetic variation and decreased risk for obesity in the Atherosclerosis Risk in Communities Study.

AIM: To investigate the effects of variation in the leptin [LEP (19A>G)] and melanocortin-4 receptor [MC4R (V103I)] genes on obesity-related traits in 13 405 African-American (AA) and white participants from the Atherosclerosis Risk in Communities (ARIC) Study. METHODS: We tested the association between the single-locus and multilocus genotypes and obesity-related measures [body mass index (BMI), body weight (BW), waist-hip ratio, waist circumference and leptin levels], adjusted for age, physical activity level, smoking status, diabetic status, prevalence of coronary heart disease, hypertension, stroke or transient ischaemic attack. RESULTS: AA and white female carriers of the MC4R I103 allele exhibited significantly lower BW than non-carriers of this allele (p < 0.05 and p < 0.01 respectively). AA female carriers of both the LEP A19 allele and the MC4R I103 allele were 63% [odds ratio (OR) = 0.37, 95% confidence interval (CI) (0.18-0.78)] less likely to be obese, and white female carriers of the same two alleles were 46% [OR = 0.54, 95% CI (0.32-0.91)] less likely to be obese, than non-carriers of the variant alleles. Female carriers of both the LEP A19 and MC4R I103 alleles had significantly lower BW (p < 0.05), BMI (p < 0.05) and plasma leptin (p < 0.01) than the non-carriers of both the alleles. Carriers of the two variant alleles had lower BMI over the 9-year course of the ARIC study and significantly lower weight gain from age 25 years. No significant joint effect of these two variants was observed in males. CONCLUSION: These results suggest that variation within the LEP and MC4R genes is associated with reduced risk for obesity in females.

Antihypertensive therapy and progression of diabetic renal disease.

A number of changes in intrarenal hemodynamics and morphology are characteristic of diabetic nephropathy. These changes include: increases in intraglomerular pressure and volume, glomerular capillary permeability to macromolecules, and mesangial matrix expansion. Most antihypertensive drugs attenuate some of the increases in these parameters. Certain antihypertensive agents, however, have effects on all these parameters. Studies in animal models of diabetes demonstrate that the angiotensin-converting enzyme (ACE) inhibitors reduce both intraglomerular volume and pressure, mesangial matrix expansion, and albuminuria. The calcium antagonists TA-3090 (diltiazem-like) and verapamil recently have been shown to have most of these effects. Conversely, the dihydropyridine calcium antagonists (nifedipine, felodipine, nitrendipine) do not attenuate increases in most of these parameters. In several clinical studies, nifedipine either did not affect or increased urinary albumin excretion in diabetic patients with renal insufficiency. Moreover, in animal models of diabetes, most dihydropyridine compounds do not prevent progression of glomerulosclerosis in spite of blood pressure control. Although the majority of clinical studies support the concept that reduction of arterial pressure preserves renal function, recent long-term clinical studies show that ACE inhibitors and heart-rate-lowering calcium antagonists (diltiazem, verapamil) attenuate progression of diabetes to a greater extent than most other agents do.

Dissemination and adoption of the Child and Adolescent Trial for Cardiovascular Health (CATCH): a case study in Texas.

The total impact of a health promotion program can be measured by the efficacy of the intervention multiplied by the extent of its implementation across the target population. The Child and Adolescent Trial for Cardiovascular Health (CATCH) was a school-based health promotion project designed to decrease fat, saturated fat, and sodium in children's diets, increase physical activity, and prevent tobacco use. This article describes the dissemination of CATCH in Texas, including the theoretical framework, strategies used, and lessons learned. To date (Fall 2000), CATCH materials have been adopted by more than 728 elementary schools in Texas.