Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000467
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
1999-10-27
Brief Title:
Child and Adolescent Trial for Cardiovascular Health CATCH
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the effectiveness of school-based risk reduction interventions involving three components environmental changes related to food consumption physical activity and smoking policy in the school classroom curriculum and family and home-based education
Detailed Description:
BACKGROUND
Coronary atherosclerosis begins in childhood and is expressed in adulthood as angina pectoris myocardial infarction or sudden death The earliest lesion in the vascular system is the fatty streak characterized by an accumulation of lipids in the intima These lesions are present in the vessels of infants and young children Whether these fatty streaks are precursors of more complex lesions is controversial However fibrous plaques intimal lesions consisting of a central core of extracellular lipids covered with a cap of fibromuscular tissue are frequently seen in children by 15 years of age In addition necropsy studies of United States battle casualties confirm the presence of advanced coronary lesions in young adults Thus it appears that the atherosclerotic process is well established in the American population by young adulthood
Epidemiologic studies in adults have found that associated with the development of coronary artery disease are a number of risk factors including age sex hypercholesterolemia hypertension cigarette smoking diabetes a family history of coronary artery disease obesity lack of physical activity and perhaps coronary prone behavior Of the modifiable factors hypercholesterolemia hypertension and cigarette smoking have the greatest predictive value
A small reduction of serum cholesterol levels in all children by a modest diet change it has been hypothesized would reduce coronary heart disease More severe dietary restriction in some cases in conjunction with medication is recommended for very high-risk pediatric populations only In addition surveillance of blood pressure avoidance of cigarette smoking and overweight and regular physical exercise are prudent recommendations for all children
The National Children and Youth Fitness Study NCYFS offered new standards for measuring fitness profiled youth exercise habits and helped to explain the contribution of exercise to fitness Nationwide 8000 fifth- through twelfth-graders in 140 schools in 19 states participated in the study between February and May 1984 Findings revealed that these youths had substantially more body fat than their counterparts in the 1960s and that approximately half of the students did not perform sufficient physical activity to maintain effective cardiorespiratory functioning Results from the 1985 national survey of drug use among high school students indicate that most initial experiences with smoking occur before high school with 13 percent of students beginning prior to tenth grade Substantial increases in smoking occur between seventh and eighth grade and inner city Hispanic students show higher smoking rates than white or Black inner city youth
Although there is debate about the cut-off point at which children might be considered at risk for coronary heart disease it is estimated that 36-60 percent of children in the United States exhibit at least one modifiable risk factor for coronary disease by the age of 12 The nations schools may provide an appropriate and efficient vehicle for reducing cardiovascular risks in large populations About 47 million children and young people attend some 115000 public and private schools These students are in school from 5 to 8 hours each day 5 days per week for nearly 36 weeks per year Furthermore the school food services provide 20 percent or more of total daily caloric intake on school days for children who select the school lunch program
Currently school-based health promotion programs are conceptualized as including curriculum and related organizational factors that support healthy behavior The existence of comprehensive programs is limited throughout the nation The results of numerous school-based nutrition studies report changes in students knowledge about nutrition Several studies based on social learning theory report changes in behavior and knowledge about nutrition Although health education interventions may succeed in increasing childrens knowledge and producing changes in behavioral intentions and behavior the behavioral changes may not be maintained unless the school environment and childrens parents reinforce the intentions
Substantial progress in the field of cigarette smoking prevention in youths has been made during the past few years Researchers have focused on the prevention of cigarette smoking for several reasons First cigarette smoking is a major risk factor for such chronic diseases as coronary heart disease cancer and emphysema Second cigarette smoking is the most widespread form of drug dependence in our society Third cigarette smoking occurs toward the very beginning of the developmental progression of substance abuse and consequently is generally regarded to be one of the so-called gateway substances
A recent review indicated that the most promising cigarette smoking prevention approaches focus on the psychosocial factors that promote initiation of cigarette smoking Such approaches fall into two general categories a those that focus on the social influences believed to promote substance use and b those that provide coping skills training designed to enhance personal and social competence Results of a recent 24-month study involving 689 sixth-grade elementary students showed that youths who received both health information and skills interventions had less intention to smoke and less cigarette use than youths who received no intervention or health information alone Prior studies using peer-led models with seventh graders report similar results
The research literature on the effects of physical activity promotion is sparse One of the few intervention studies on physical activity with school children to report increased endurance fitness and reduced body fat associated with an intensive daily physical program is the Australian Health and Fitness Study This randomized controlled trial was designed to compare the effects of integrated physical activity and health education programs on body fat blood pressure and endurance fitness in 10-year-old school children in primary schools located in Adelaide The Oslo Youth Study was successful in designing and implementing within the school system a comprehensive health educational program involving grades 5-7 Positive results were obtained in the intervention group relative to the reference group with reductions in smoking onset improved eating habits and increased physical activity over a two-year period
Over the past ten years school-based research studies have become more theoretically-grounded and have employed more sophisticated research design strategies and measurement techniques The prevention of cigarette smoking has been the major focus of this research There is still considerable need to build the base of scientific knowledge about the development of dietary smoking and exercise habits during childhood and about the interventions that are effective in school settings
DESIGN NARRATIVE
CATCH consisted of a three-and-a-half year feasibility study conducted from September 1987 through March 1991 the main trial beginning in April 1991 and the Tracking Study in 1996 a follow-up study to allow measurements on the cohort through ages 13 to 14 years The purpose of the feasibility study was to test the acceptability of the interventions and measurements in 1471 third fourth and fifth grade boys and girls ages 7 to 11 The main components of the Phase I intervention programs at the eight schools included classroom curricula for the third fourth and fifth grades home curricula designed to involve parents and children in CATCH activities at home and family fun nights to enhance family involvement a physical activity program centered around a new physical activity curriculum and a school nutrition program for school food service directors and staff Blood samples were obtained from 1045 children during risk factor screening Other measurements included blood pressure height weight triceps and subscapular skinfolds Nutrient intake was pilot-tested with an interactive 24-hour recall approach supplemented by food records a home food inventory and follow-up calls to parents Physical activity was measured with a physical activity interview and the Caltrac motion sensor
The main trial or Phase II beginning in 1991 and ending in 1994 included two study groups an Intervention Group and a Control Group with a total of approximately 8000 students The measurement cohort included 5107 students The Intervention Group received a school-based program consisting of the CATCH curriculum the physical education program the school food service program and programs to establish smoke-free schools One-half of the Intervention Group received the same school-based program plus a family-based program The Control Group received the usual health curriculum of the control schools but none of the CATCH interventions The primary endpoints at the school level were reduction in fat and saturated fat in school lunches and increased moderate to vigorous activity in PE classes The primary endpoint at the student level was serum cholesterol change between the third and fifth grades Secondary endpoints included health knowledge self-efficacy and behavioral skills that related to the adoption and maintenance of cardiovascular health behaviors dietary fat intake dietary sodium intake physical activity and systolic blood pressure The unit of randomization was the elementary school Schools were recruited for participation and then randomly assigned to the study groups Twenty-four schools were recruited from each of the four participating field centers for a total of 96 schools In each center ten of 24 schools were assigned to the Control Group and 14 to the Intervention Group Among the 14 intervention schools seven were randomly assigned to the school-based intervention alone and seven to the school-based and family component Measures of behavioral outcome and process variables were made during each grade from three through five Physiological measurements were made at baseline in grade three and at the end of grade five Final measurements were completed in May 1994 Close-out and final data analysis were conducted in the latter part of 1995 and in 1996 The major results paper was published in JAMA in March 1996 Ten major mainstream papers were published in Preventive Medicine in 1996
The Tracking Study of CATCH III beginning in December 1994 followed the cohort through early adolescence in the sixth through eighth grades The objectives were to measure the effects of CATCH II intervention programs on subsequent smoking prevalence rates during the end of the eighth grade and to observe the onset development and inter-correlation of cardiovascular risk factors from early to middle adolescence in the cohort There were no CATCH interventions Psychosocial measures dietary fitness and smoking data were collected annually The full panel of physiological measures and biochemical validation of smoking was conducted during the last semester of eighth grade CATCH III ended in November 1999 The study was active through November 2000 under U01-HL-47098 the coordinating center
In August of 1996 a homocysteine substudy was added to CATCH The substudy used serum samples collected in eighth graders in the spring of 1997 for analyses of homocysteine folic acid vitamin B-12 vitamin B-6 lipids lipoproteins blood pressure weight and height A mail survey was conducted to collect data on the childrens family history of cardiovascular disease and vitamin supplementation The results paper was published in JAMA in 1998
The CATCH-ON Study began in 1998 Its purpose was to assess the degree to which CATCH intervention goals reduction of fat and saturated fat in school meals increase in physical activity no tobacco use and implementation of the CATCH curriculum were maintained or institutionalized in the original 56 CATCH intervention schools and in 20 control schools CATCH-ON was Phase IV that ended March 31 2001 To determine the influence of secular trends the outcome measures were also assessed in 12 newly recruited unexposed schools Measures of school climate teacher and staff characteristics school turbulence and school facilities and resources were assessed to help explain the variation in the degree of institutionalization in the CATCH intervention and control schools
Coronary atherosclerosis begins in childhood and is expressed in adulthood as angina pectoris myocardial infarction or sudden death The earliest lesion in the vascular system is the fatty streak characterized by an accumulation of lipids in the intima These lesions are present in the vessels of infants and young children Whether these fatty streaks are precursors of more complex lesions is controversial However fibrous plaques intimal lesions consisting of a central core of extracellular lipids covered with a cap of fibromuscular tissue are frequently seen in children by 15 years of age In addition necropsy studies of United States battle casualties confirm the presence of advanced coronary lesions in young adults Thus it appears that the atherosclerotic process is well established in the American population by young adulthood
Epidemiologic studies in adults have found that associated with the development of coronary artery disease are a number of risk factors including age sex hypercholesterolemia hypertension cigarette smoking diabetes a family history of coronary artery disease obesity lack of physical activity and perhaps coronary prone behavior Of the modifiable factors hypercholesterolemia hypertension and cigarette smoking have the greatest predictive value
A small reduction of serum cholesterol levels in all children by a modest diet change it has been hypothesized would reduce coronary heart disease More severe dietary restriction in some cases in conjunction with medication is recommended for very high-risk pediatric populations only In addition surveillance of blood pressure avoidance of cigarette smoking and overweight and regular physical exercise are prudent recommendations for all children
The National Children and Youth Fitness Study NCYFS offered new standards for measuring fitness profiled youth exercise habits and helped to explain the contribution of exercise to fitness Nationwide 8000 fifth- through twelfth-graders in 140 schools in 19 states participated in the study between February and May 1984 Findings revealed that these youths had substantially more body fat than their counterparts in the 1960s and that approximately half of the students did not perform sufficient physical activity to maintain effective cardiorespiratory functioning Results from the 1985 national survey of drug use among high school students indicate that most initial experiences with smoking occur before high school with 13 percent of students beginning prior to tenth grade Substantial increases in smoking occur between seventh and eighth grade and inner city Hispanic students show higher smoking rates than white or Black inner city youth
Although there is debate about the cut-off point at which children might be considered at risk for coronary heart disease it is estimated that 36-60 percent of children in the United States exhibit at least one modifiable risk factor for coronary disease by the age of 12 The nations schools may provide an appropriate and efficient vehicle for reducing cardiovascular risks in large populations About 47 million children and young people attend some 115000 public and private schools These students are in school from 5 to 8 hours each day 5 days per week for nearly 36 weeks per year Furthermore the school food services provide 20 percent or more of total daily caloric intake on school days for children who select the school lunch program
Currently school-based health promotion programs are conceptualized as including curriculum and related organizational factors that support healthy behavior The existence of comprehensive programs is limited throughout the nation The results of numerous school-based nutrition studies report changes in students knowledge about nutrition Several studies based on social learning theory report changes in behavior and knowledge about nutrition Although health education interventions may succeed in increasing childrens knowledge and producing changes in behavioral intentions and behavior the behavioral changes may not be maintained unless the school environment and childrens parents reinforce the intentions
Substantial progress in the field of cigarette smoking prevention in youths has been made during the past few years Researchers have focused on the prevention of cigarette smoking for several reasons First cigarette smoking is a major risk factor for such chronic diseases as coronary heart disease cancer and emphysema Second cigarette smoking is the most widespread form of drug dependence in our society Third cigarette smoking occurs toward the very beginning of the developmental progression of substance abuse and consequently is generally regarded to be one of the so-called gateway substances
A recent review indicated that the most promising cigarette smoking prevention approaches focus on the psychosocial factors that promote initiation of cigarette smoking Such approaches fall into two general categories a those that focus on the social influences believed to promote substance use and b those that provide coping skills training designed to enhance personal and social competence Results of a recent 24-month study involving 689 sixth-grade elementary students showed that youths who received both health information and skills interventions had less intention to smoke and less cigarette use than youths who received no intervention or health information alone Prior studies using peer-led models with seventh graders report similar results
The research literature on the effects of physical activity promotion is sparse One of the few intervention studies on physical activity with school children to report increased endurance fitness and reduced body fat associated with an intensive daily physical program is the Australian Health and Fitness Study This randomized controlled trial was designed to compare the effects of integrated physical activity and health education programs on body fat blood pressure and endurance fitness in 10-year-old school children in primary schools located in Adelaide The Oslo Youth Study was successful in designing and implementing within the school system a comprehensive health educational program involving grades 5-7 Positive results were obtained in the intervention group relative to the reference group with reductions in smoking onset improved eating habits and increased physical activity over a two-year period
Over the past ten years school-based research studies have become more theoretically-grounded and have employed more sophisticated research design strategies and measurement techniques The prevention of cigarette smoking has been the major focus of this research There is still considerable need to build the base of scientific knowledge about the development of dietary smoking and exercise habits during childhood and about the interventions that are effective in school settings
DESIGN NARRATIVE
CATCH consisted of a three-and-a-half year feasibility study conducted from September 1987 through March 1991 the main trial beginning in April 1991 and the Tracking Study in 1996 a follow-up study to allow measurements on the cohort through ages 13 to 14 years The purpose of the feasibility study was to test the acceptability of the interventions and measurements in 1471 third fourth and fifth grade boys and girls ages 7 to 11 The main components of the Phase I intervention programs at the eight schools included classroom curricula for the third fourth and fifth grades home curricula designed to involve parents and children in CATCH activities at home and family fun nights to enhance family involvement a physical activity program centered around a new physical activity curriculum and a school nutrition program for school food service directors and staff Blood samples were obtained from 1045 children during risk factor screening Other measurements included blood pressure height weight triceps and subscapular skinfolds Nutrient intake was pilot-tested with an interactive 24-hour recall approach supplemented by food records a home food inventory and follow-up calls to parents Physical activity was measured with a physical activity interview and the Caltrac motion sensor
The main trial or Phase II beginning in 1991 and ending in 1994 included two study groups an Intervention Group and a Control Group with a total of approximately 8000 students The measurement cohort included 5107 students The Intervention Group received a school-based program consisting of the CATCH curriculum the physical education program the school food service program and programs to establish smoke-free schools One-half of the Intervention Group received the same school-based program plus a family-based program The Control Group received the usual health curriculum of the control schools but none of the CATCH interventions The primary endpoints at the school level were reduction in fat and saturated fat in school lunches and increased moderate to vigorous activity in PE classes The primary endpoint at the student level was serum cholesterol change between the third and fifth grades Secondary endpoints included health knowledge self-efficacy and behavioral skills that related to the adoption and maintenance of cardiovascular health behaviors dietary fat intake dietary sodium intake physical activity and systolic blood pressure The unit of randomization was the elementary school Schools were recruited for participation and then randomly assigned to the study groups Twenty-four schools were recruited from each of the four participating field centers for a total of 96 schools In each center ten of 24 schools were assigned to the Control Group and 14 to the Intervention Group Among the 14 intervention schools seven were randomly assigned to the school-based intervention alone and seven to the school-based and family component Measures of behavioral outcome and process variables were made during each grade from three through five Physiological measurements were made at baseline in grade three and at the end of grade five Final measurements were completed in May 1994 Close-out and final data analysis were conducted in the latter part of 1995 and in 1996 The major results paper was published in JAMA in March 1996 Ten major mainstream papers were published in Preventive Medicine in 1996
The Tracking Study of CATCH III beginning in December 1994 followed the cohort through early adolescence in the sixth through eighth grades The objectives were to measure the effects of CATCH II intervention programs on subsequent smoking prevalence rates during the end of the eighth grade and to observe the onset development and inter-correlation of cardiovascular risk factors from early to middle adolescence in the cohort There were no CATCH interventions Psychosocial measures dietary fitness and smoking data were collected annually The full panel of physiological measures and biochemical validation of smoking was conducted during the last semester of eighth grade CATCH III ended in November 1999 The study was active through November 2000 under U01-HL-47098 the coordinating center
In August of 1996 a homocysteine substudy was added to CATCH The substudy used serum samples collected in eighth graders in the spring of 1997 for analyses of homocysteine folic acid vitamin B-12 vitamin B-6 lipids lipoproteins blood pressure weight and height A mail survey was conducted to collect data on the childrens family history of cardiovascular disease and vitamin supplementation The results paper was published in JAMA in 1998
The CATCH-ON Study began in 1998 Its purpose was to assess the degree to which CATCH intervention goals reduction of fat and saturated fat in school meals increase in physical activity no tobacco use and implementation of the CATCH curriculum were maintained or institutionalized in the original 56 CATCH intervention schools and in 20 control schools CATCH-ON was Phase IV that ended March 31 2001 To determine the influence of secular trends the outcome measures were also assessed in 12 newly recruited unexposed schools Measures of school climate teacher and staff characteristics school turbulence and school facilities and resources were assessed to help explain the variation in the degree of institutionalization in the CATCH intervention and control schools
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL039870 | NIH | None | httpsreporternihgovquickSearchU01HL039870 |