Cardiovascular risk factors in adolescents with prediabetes.

AIMS: Adolescents with Type 2 diabetes are more likely to have cardiovascular disease (CVD) risk factors but there are few data available among adolescents with prediabetes. We characterized CVD risk factors among adolescents with prediabetes in the USA and compared levels of those risk factors with adolescents with normal glucose. METHODS: The 2005-2014 National Health and Nutrition Examination Survey, a nationally representative cross-sectional survey, included 2843 adolescents aged 12-19 years after excluding those with diabetes. Prediabetes was based on an HbA1c , a fasting plasma glucose or a 2-h plasma glucose. We determined cardiometabolic risk factors in adolescents using age-appropriate cut-off points. We calculated odds ratios (OR) and 95% confidence intervals (CI) of these outcomes associated with having prediabetes compared with normal glucose levels. RESULTS: The weighted prevalence of prediabetes was 17.4%. After adjustment, prediabetes (vs. normal glucose) was associated with obesity (OR 1.86, 95% CI 1.35-2.55), low HDL-cholesterol (OR 1.62, 95% CI 1.08-2.44), high triglycerides (OR 1.61, 95% CI 1.12-2.30) and elevated liver transaminase (OR 2.09, 95% CI 1.19-3.67), but not with hypertension (OR 1.77, 95% CI 0.88-3.54), elevated total cholesterol (OR 1.30, 95% CI 0.82-2.06), elevated LDL-cholesterol (OR 1.59, 95% CI 0.88-2.88) or albuminuria (OR 1.24, 95% CI 0.76-2.02). CONCLUSIONS: US adolescents with prediabetes are more likely to have obesity, low HDL-cholesterol, high triglycerides and elevated liver transaminase than adolescents with normal glucose. Addressing prediabetes in youth is important for the prevention of Type 2 diabetes and long-term comorbidity.

A recess intervention to promote moderate-to-vigorous physical activity.

BACKGROUND: Schools provide a prime environment for interventions that attempt to increase physical activity and prevent obesity. OBJECTIVE: This study examined the effect of a 30-min, structured recess using 22 games of known energy expenditure on moderate-to-vigorous physical activity when compared to free play implemented with third graders from two elementary schools over 9 weeks. METHODS: Moderate-to-vigorous physical activity and other cardiovascular risk factors were assessed pre- and post-intervention in 27 children. RESULTS: Moderate-to-vigorous physical activity during recess increased significantly in intervention school children from 6.9 ± 0.8 to 14.9 ± 0.9 min pre- and post-intervention, respectively (adjusted mean change 8.0 ± 1.1; P < 0.0001), with no differences by gender or body mass index (BMI). In-school, moderate-to-vigorous physical activity also increased significantly more for intervention compared to control children (adjusted mean change 14 ± 4 min vs. 3 ± 3 min; P = 0.014, respectively). CONCLUSION: There was no significant difference in BMI and cardiovascular risk factors. A structured recess is feasible to implement and can significantly increase moderate-to-vigorous physical activity.

Impact of community intervention to reduce patient delay time on use of reperfusion therapy for acute myocardial infarction: rapid early action for coronary treatment (REACT) trial. REACT Study Group.

BACKGROUND: Reperfusion therapy for acute myocardial infarction (AMI) is a time-dependent intervention that can reduce infarct-related morbidity and mortality. Out-of-hospital patient delay from symptom onset until emergency department (ED) presentation may reduce the expected benefit of reperfusion therapy. OBJECTIVE: To determine the impact of a community educational intervention to reduce patient delay time on the use of reperfusion therapy for AMI. METHODS: This was a randomized, controlled community-based trial to enhance patient recognition of AMI symptoms and encourage early ED presentation with resultant increased reperfusion therapy rates for AMI. The study took place in 44 hospitals in 20 pair-matched communities in five U.S. geographic regions. Eligible study subjects were non-institutionalized patients without chest injury (aged > or =30 years) who were admitted to participating hospitals and who received a hospital discharge diagnosis of AMI (ICD 410); n = 4,885. For outcome assessment, patients were excluded if they were without survival data (n = 402), enrolled in thrombolytic trials (n = 61), receiving reperfusion therapy >12 hours after ED arrival (n = 628), or missing symptom onset or reperfusion times (n = 781). The applied intervention was an educational program targeting community organizations and the general public, high-risk patients, and health professionals in target communities. The primary outcome was a change in the proportion of AMI patients receiving early reperfusion therapy (i.e., within one hour of ED arrival or within six hours of symptom onset). Trends in reperfusion therapy rates were determined after adjustment for patient demographics, presenting blood pressure, cardiac history, and insurance status. Four-month baseline was compared with the 18-month intervention period. RESULTS: Of 3,013 selected AMI patients, 40% received reperfusion therapy. Eighteen percent received therapy within one hour of ED arrival (46% of treated patients), and 32% within six hours of symptom onset (80% of treated patients). No significant difference in the trends in reperfusion therapy rates was attributable to the intervention, although increases in early reperfusion therapy rates were noted during the first six months of the intervention. A significant association of early reperfusion therapy use with ambulance use was identified. CONCLUSIONS: Community-wide educational efforts to enhance patient response to AMI symptoms may not translate into sustained changes in reperfusion practices. However, an increased odds for early reperfusion therapy use during the initiation of the intervention and the association of early therapy with ambulance use suggest that reperfusion therapy rates can be enhanced.

Design and implementation of the North American Pediatric Cardiomyopathy Registry.

The Pediatric Cardiomyopathy Registry (PCMR) was established to describe the epidemiologic features and clinical course of selected cardiomyopathies in patients aged 18 years or younger and to promote the development of etiology-specific treatments. Sixty-one private and institutional pediatric cardiomyopathy practices in the United States and Canada were recruited to participate in the PCMR. The registry consists of a prospective, population-based cohort of patients in 2 regions (New England and the Central Southwestern United States) and a retrospective cohort of patients diagnosed between 1991 and 1996. Annual follow-up data are collected on all patients. As of June 1999, the PCMR consisted of 337 prospectively identified and 990 retrospectively identified patients. The PCMR has demonstrated the feasibility of establishing a large database of sociodemographic and clinical information on children with pediatric cardiomyopathy. Through this cooperative effort, the PCMR will obtain precise estimates of the incidence of pediatric cardiomyopathy and a better understanding of the natural history of this disease.

Prehospital delay in patients hospitalized with heart attack symptoms in the United States: the REACT trial. Rapid Early Action for Coronary Treatment (REACT) Study Group.

BACKGROUND: The use of thrombolytic therapy for patients with myocardial infarction has been limited by patient delay in seeking care. We sought to characterize prehospital delay in patients hospitalized for evaluation of heart attack symptoms. METHODS AND RESULTS: The Rapid Early Action for Coronary Treatment (REACT) is a multicenter, randomized community trial designed to reduce patient delay. At baseline, data were abstracted from the medical records of 3783 patients hospitalized for evaluation of heart attack symptoms in 20 communities. The median prehospital delay was 2.0 hours; 25% of patients delayed longer than 5.2 hours. In a multivariable analysis, delay time was longer among non-Hispanic blacks than among non-Hispanic whites, longer at older ages, longer among Medicaid-only recipients and shorter among Medicare recipients than among privately insured patients, and shorter among patients who used an ambulance. CONCLUSIONS: The observed pattern of differences is consistent with the contention that demographic, cultural, and/or socioeconomic barriers exist that impede rapid care seeking.

Three-year maintenance of improved diet and physical activity: the CATCH cohort. Child and Adolescent Trial for Cardiovascular Health.

OBJECTIVE: To assess differences through grade 8 in diet, physical activity, and related health indicators of students who participated in the Child and Adolescent Trial for Cardiovascular Health (CATCH) school and family intervention from grades 3 through 5. DESIGN: Follow-up of the 4-center, randomized, controlled field trial with 56 intervention and 40 control elementary schools. PARTICIPANTS: We studied 3714 (73%) of the initial CATCH cohort of 5106 students from ethnically diverse backgrounds in California, Louisiana, Minnesota, and Texas at grades 6, 7, and 8. RESULTS: Self-reported daily energy intake from fat at baseline was virtually identical in the control (32.7%) and intervention (32.6%) groups. At grade 5, the intake for controls remained at 32.2%, while the intake for the intervention group declined to 30.3% (P<.001). At grade 8, the between-group differential was maintained (31.6% vs 30.6%, P = .01). Intervention students maintained significantly higher self-reported daily vigorous activity than control students (P = .001), although the difference declined from 13.6 minutes in grade 5 to 11.2, 10.8, and 8.8 minutes in grades 6, 7, and 8, respectively. Significant differences in favor of the intervention students also persisted at grade 8 for dietary knowledge and dietary intentions, but not for social support for physical activity. No impact on smoking behavior or stages of contemplating smoking was detected at grade 8. No significant differences were noted among physiologic indicators of body mass index, blood pressure, or serum lipid and cholesterol levels. CONCLUSION: The original CATCH results demonstrated that school-level interventions could modify school lunch and school physical education programs as well as influence student behaviors. This 3-year follow-up without further intervention suggests that the behavioral changes initiated during the elementary school years persisted to early adolescence for self-reported dietary and physical activity behaviors.

Distribution of and factors associated with serum homocysteine levels in children: Child and Adolescent Trial for Cardiovascular Health.

CONTEXT: Although evidence suggests that homocysteine is a risk factor for cardiovascular disease in adults, little information exists on homocysteine levels in children. OBJECTIVES: To describe the distribution of serum homocysteine concentrations among children and to examine the association between homocysteine levels and several characteristics, including serum levels of folic acid and vitamins B12 and B6. DESIGN: Cross-sectional analysis. SETTING: School-based cohort from California, Louisiana, Minnesota, and Texas. PARTICIPANTS: A total of 3524 US schoolchildren, aged 13 and 14 years, from the Child and Adolescent Trial for Cardiovascular Health (completed in 1994). Measurement was conducted in 1997. MAIN OUTCOME MEASURE: Nonfasting serum total homocysteine concentration. RESULTS: The distribution of homocysteine values ranged from 0.1 to 25.7 micromol/L (median, 4.9 micromol/L). Geometric mean homocysteine concentration was significantly higher in boys (5.22 micromol/L) than girls (4.84 micromol/L); blacks (5.51 micromol/L) than whites (4.96 micromol/L) or Hispanics (4.93 micromol/L); nonusers of multivitamins (5.09 micromol/L) than users (4.82 micromol/L); and smokers (5.19 micromol/L) than nonsmokers (5.00 micromol/ L). Serum homocysteine was significantly inversely correlated with serum levels of folic acid (r= -0.36; P = .001), vitamin B12 (r = -0.21; P = .001), and vitamin B6 (r = -0.18; P = .001). Serum homocysteine was not significantly associated with serum lipid levels or family history of cardiovascular disease and was only weakly related to body mass index and systolic blood pressure. After multivariate adjustment, homocysteine remained independently associated with sex, race, serum folic acid and vitamin B12 levels, and systolic blood pressure. CONCLUSIONS: The distribution of homocysteine levels in children is substantially lower than that observed for adults; however, a small percentage of children are still potentially at elevated risk for future cardiovascular disease. Serum folic acid may be an important determinant of homocysteine levels in children.

Operational design and quality control in the CATCH multicenter Trial.

BACKGROUND: The Child and Adolescent Trial for Cardiovascular Health (CATCH) was the first multicenter school-based research study to employ the fundamentals of clinical trials including the standardized protocol and Manuals of Operation, a steering committee for study governance, a distributed data system, an extensive quality control system, and a Data and Safety Monitoring Board. METHOD: CATCH tested the effectiveness of changes in school lunches, physical education, smoking policy, curricula, and family activities. Ninety-six elementary schools in four states were randomized to intervention or control conditions. The baseline cohort comprised 5, 106 ethnically diverse third graders followed through fifth grade. RESULTS: The percentages of calories from fat and saturated fat were reduced significantly more in the intervention school lunches than among the controls. Significant increases in moderate to vigorous activity levels in existing physical education classes were made as well. Changes in self-reported dietary, physical activity, and psychosocial measures were significant. There were no significant differences in the physiological measures. Measurement error was generally low for all physiologic measures except skinfolds, indicating a high level of reliability. Across all sites, the coefficients of variation for lipids, height, and weight were less than 3%, whereas for skinfolds, they were considerably higher, ranging from 6 to 8%. Intraclass correlations for lipid studies were also uniformly high at 0.99. Interobserver agreement scores for SOFIT were greater than 90% for 9 of the 11 activities observed. Data entry error rates were low with less than five errors per 1,000 fields for all forms. CONCLUSIONS: The CATCH results provided more scientific evidence on the importance of schools in the population approach to health promotion. Many of the strategies used in this complex multicenter trial in the areas of design and analysis, measurement, training, data management, and quality control protocols might be appropriate for adoption in other studies.

Cardiovascular risk factors among children after a 2 1/2-year intervention-The CATCH Study.

BACKGROUND: Cardiovascular risk factors and related behaviors begin during youth. METHODS: As part of the Child and Adolescent Trial for Cardiovascular Health, 4,019 children from four states and representing multiple ethnic groups were measured for selected risk factors both at baseline and after 2(1/2) years of intervention. Common protocols were used for both examinations at the four sites. RESULTS: Overall, changes in obesity, blood pressure, and serum lipids in the intervention group, compared with the control group, were not statistically significant. Total cholesterol, the primary physiologic outcome measure, decreased by 1.3 mg/dl over time in the intervention group and by 0.9 mg/dl (P > 0.05) in the control group. Different risk factor patterns for boys and girls and among three ethnic groups were noted. CONCLUSIONS: Although the school-based program effected significant institutional changes in food service and physical education class and although the children made significant changes in eating and physical activity behaviors, these did not translate to significant changes in risk factors at these ages. These behavioral changes, however, if sustained into adulthood, have the potential to influence cardiovascular risk reduction.

Changes in the nutrient content of school lunches: results from the CATCH Eat Smart Food service Intervention.

BACKGROUND: The Child and Adolescent Trial for Cardiovascular Health (CATCH) tested the effectiveness of a multilevel intervention aimed at promoting a healthful school environment and positive eating and physical activity behaviors in children. The CATCH Eat Smart Program targeted the school food service staff and aimed to lower the total fat, saturated fat, and sodium content of school meals. METHODS: The Eat Smart intervention was conducted in 56 intervention schools over a 2(1/2)-year period.+Five consecutive days of school menu, recipe, and vendor product information were collected from intervention and control schools at three intervals, Fall 1991, Spring 1993, and Spring 1994, to assess the nutrient content of school menus as offered. RESULTS: There was a significantly greater mean reduction in the percentage of calories from total fat (adjusted mean difference -4.1%; P < 0.0001) and saturated fat (adjusted mean difference -1.3%; P = 0.003) in intervention compared with control schools from baseline to follow-up. Although the sodium content of school lunches increased in both conditions, the mean increase was significantly lower in intervention schools (adjusted mean difference -89 mg; P = 0.034). There were no statistically significant differences for total amounts of cholesterol, carbohydrate, protein, dietary fiber, total sugars, calcium, iron, vitamin A value, and vitamin C. Average total calories decreased significantly; however, the mean total calories (683 kcal) for intervention schools remained above one-third of the Recommended Dietary Allowances for this age group. CONCLUSIONS: The CATCH Eat Smart intervention successfully lowered the total fat and saturated fat content of school lunches as offered, while maintaining recommended amounts of calories and essential nutrients.

Perspectives on the School Nutrition Dietary Assessment Study from the Child and Adolescent Trial for Cardiovascular Health.

The School Nutrition Dietary Assessment Study provides current data on the nutritional quality and adequacy of the National School Lunch Program (NSLP) and the School Breakfast Program (SBP) as well as on the dietary intakes of students participating in these programs. The study demonstrates that the NSLP and SBP meals and children's total diets do not conform to the recommendations of the US Department of Agriculture and the National Research Council and confirms the need to improve the nutritional quality of the nation's school meal program and student's overall dietary intakes. In this regard, the Child and Adolescent Trial for Cardiovascular Health (CATCH) is the first collaborative, school-based field trial that tests the effectiveness of a multi-level intervention designed to reduce the fat, saturated fat, and sodium content of school meals and student's diets. This commentary highlights the findings and questions raised by the School Nutrition Dietary Assessment Study and presents an overview of CATCH, including the implications and significant questions that can be addressed by this intervention study.

Design of process evaluation within the Child and Adolescent Trial for Cardiovascular Health (CATCH).

Process evaluation complements outcome evaluation by providing data to describe how a program was implemented, how well the activities delivered fit the original design, to whom services were delivered, the extent to which the target population was reached, and factors external to the program that may compete with the program effects. The process evaluation system used in the Child and Adolescent Trial for Cardiovascular Health (CATCH) is presented in this paper. The conceptual model underlying the CATCH process evaluation system is described, and process measures and data collection protocols are reviewed. Functions of process evaluation data in the trial include: (1) describing the implementation of the program, (2) quality control and monitoring, and (3) explaining program effects. The importance of incorporating process evaluation into final outcome analyses and assessments of program impact is emphasized.

CATCH: food service program process evaluation in a multicenter trial.

Process evaluation is an essential element of a multicenter trial in order to explain study outcomes and monitor intervention progress. This paper presents the process evaluation model for the Eat Smart School Nutrition Program, the food service intervention component of the Child and Adolescent Trial for Cardiovascular Health (CATCH), and describes the process evaluation strategies developed to assess this program. The paper details (1) measures of program implementation including training, support visits, and program promotion, (2) food service staff characteristics, and (3) measures of mediating variables including secular trends and school meal participation.

CATCH: family process evaluation in a multicenter trial.

The Child and Adolescent Trial for Cardiovascular Health (CATCH) is an elementary school cardiovascular health education field trial in progress in San Diego, California, New Orleans, Louisiana, Minneapolis, Minnesota, and Austin, Texas. Because a significant part of a child's health behaviors are shaped within the home, CATCH is evaluating whether the effects of the school-based program are enhanced by the inclusion of a home-based program. A 7 x 7 x 10 randomized design with 7 school-only and 7 school-plus-family intervention schools, along with 10 control schools is implemented at each site. The CATCH family intervention is implemented during Grades 3 through 5 and consists of home-based curricula and Family Fun Nights focusing on healthier eating and increased physical activity during Grades 3 and 4, along with a smoking prevention curriculum in Grade 5. CATCH is examining the effectiveness of family (household) involvement through changes in students' dietary intake of fat and sodium. This paper describes the process evaluation methods used to document the extent of participation in the family program. Data reported for the third-grade Family Fun Nights held in the 28 family schools across all sites reflected an average student participation rate of 67%. The average family member to student ratio was approximately 2:1. Participation by all third-grade teachers and the majority of physical education specialists was observed.