One of the important announcements coming out of the American Diabetes Association's 70th Scientific Sessions were the results of a little known NIH study titled, "The Healthy Study: Interventions to reduce early diabetes risk." This may be a new model of how we can prevent our children from getting diabetes....
The NIH made a major investment in our children by modifying lifestyles in the grade schools to prevent a number of diseases. They also have a website that has all of the materials used in the program available at no cost: www.healthystudy.com.
A broad-based program to fight obesity and diabetes, aimed at US middle-school students and conducted directly by their teachers and other local school officials and designed to profoundly change not only diet, but also attitudes about food and fitness, appeared to improve measures of adiposity, insulin resistance, and other diabetes risk factors in a prospective randomized trial. The findings were presented here on June 28 at the 70th ADA Scientific Sessions and published online June 27, 2010, in the New England Journal of Medicine.
However, there wasn't a significant difference between students at schools that ran the three-year program and control schools, where the program wasn't instituted, in the study's primary end point: change in the prevalence of kids who were overweight or obese, defined as a body-mass index (BMI) in the >85th percentile. The prevalence fell similarly at schools with and without the intervention program.
By 1999, some pediatric centers, especially those in inner cities, were seeing more new cases of Type 2 diabetes than Type 1.
The program, which followed the students from the beginning of sixth grade to the end of eighth grade, also did not show a significant benefit in lowering the overall prevalence of kids who were obese at its conclusion -- that is, who finished the study in the >95th percentile for BMI. That prevalence fell by 19% at program compared with nonprogram schools, but the difference fell just short of significance at p=0.05.
However, the proportion of kids with waist circumference in the >90th percentile fell significantly more (p=0.04) at program schools. Students at those schools also had significantly (p=0.04) smaller increases in fasting insulin levels over the three years.
The program's benefits in the overall school populations were even more pronounced, and more solidly significant, among the approximately one-half of students in the >85th percentile for BMI at the beginning of sixth grade.
"This would suggest that, although the intervention did not meet its primary outcome of altering the combined prevalence of overweight or obesity, it did have effects on obesity and other important risk factors for Type 2 diabetes, Dr. Gary D. Foster (Temple University, Philadelphia, PA) said at a briefing for medical reporters. Foster chaired the HEALTHY study -- a name, not an acronym, chosen by students who participated in the comprehensive program.
He also said that the falling overweight/obesity rates at schools with and without the intervention program are consistent with national-level trends observed in other analyses that suggest that "rates of obesity in high-risk children in sixth to eighth grade appear not to be steady or increasing, but actually appear to be declining."
The HEALTHY study randomized 42 schools in seven regions of the US to follow or not follow the comprehensive intervention program. Schools qualified for participation if at least 50% of their students were members of a minority (primarily Hispanic or African American) or at least 50% qualified for government-subsidized meal programs; minority and low-income kids, the researchers note, are known to be at increased risk for both obesity and diabetes. Girls made up 53% of the 4,603 students tracked in the study, who had to be free of recognized diabetes at baseline.
At the press briefing, Dr. Griffin P. Rodgers (National Institutes of Health, Bethesda, MD), who is director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the HEALTHY study's primary underwriter, but who isn't one of its investigators, underscored the importance of targeting kids at increased risk for diabetes. "Earlier onset of diabetes may foreshadow earlier appearance of complications," he noted.
When the HEALTHY study and its six preceding pilot studies were initially in development, he continued, "obesity rates in American youth had been climbing steadily for two decades. Then, medical centers around the country began reporting a disturbing new trend, Type 2 diabetes was increasingly being diagnosed in youths, especially black, Hispanic, and American Indian adolescents. By 1999, some pediatric centers, especially those in inner cities, were seeing more new cases of Type 2 diabetes than Type 1. We needed to find ways to contain the rising rate of Type 2 diabetes in kids, and schools were a logical place to start."
Dr. Cynthia L. Ogden (Centers for Disease Control and Prevention, Atlanta, GA), also on hand at the briefing but not a HEALTHY study researcher, showed 2007/08 data from the National Health and Nutrition Examination Survey suggesting that 31.7% of US children aged two to 19 are overweight or obese, amounting to 23.4 million children. Among them, she said, are the 17% of US kids in that age group, a total of about 12.5 million, who qualify as obese.
Also, Rodgers said, the HEALTHY pilot trials suggested that up to 40% of eighth graders at schools with high-risk populations had elevated fasting glucose levels. "So the question became, can changes in schools -- namely, longer and more intense gym classes, healthier food choices, and classroom activities that promote healthy behavior -- lower risk factors for Type 2 diabetes in youth?"
The program consisted of interventions grouped in four domains. (Details and the materials used are available on the study's website.) The nutritional component called for healthy improvements in the quality and quantity of food and beverages available at the schools' cafeterias, snack bars, and vending machines, and even at fundraisers and classroom parties, according to Hirst. Available choices shifted to those lower in fat, higher in fiber, heavier on fruit and vegetables, and lower in added sugar.
The physical-activity component was aimed at increasing both participation and activity levels in physical education classes, emphasizing activities that raised the heart rate.
Dr. Kathryn Hirst (George Washington University School of Public Health, Washington, DC) provided more details of the intervention program, which consisted of "multiple components that were designed to change the school environment radically." Experts on the study's staff at its seven regional field offices provided "training, guidance, assistance, materials, and support" for instituting the program to the faculties and staff at each of the schools, "who were the ones who actually delivered the intervention," she noted.
Teachers received instruction on holding school-wide events that promoted physical activity. Minimum weekly durations of physical education classes were instituted.
The third component, focused on behavior, according to the report, promoted classroom and family-outreach activities to educate and sharpen self-awareness and decision-making, self-monitoring, and goal-setting skills consistent with the overall program.
The fourth component, communication, focused on the use of marketing techniques to promote the program's goals within the schools and establish a "brand" to characterize and identify the changes to menus and physical activities that were part of the program.
Healthy Study Group. A school-based intervention for diabetes risk reduction. New Engl J Med 2010; DOI:10.1056/NEJMoa1001933. Available at www.nejm.org.
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