In this seven year cooperative agreement we propose to test a school- based intervention to prevent type 2 diabetes (T2D) in children and adolescents. Obesity is increasing markedly in American youth, and this increase, which is already accompanied by an explosion in the incidence of T2D in youth, is expected to further increase unless effective interventions can be instituted. The proposed study will test an environmental and lifestyle intervention that could serve as a model for long-term school-based interventions to reduce obesity and prevent T2DM in schools throughout the US.
The specific aim of this proposal is to test a longitudinal school-based intervention to prevent T2D and insulin resistance in elementary and middle school youth. The primary focus of the intervention will be to add a prescribed physical activity program to the school curriculum for one, two or three years, and to modify access of youth to soft drinks at school. Additional components of the intervention will be intermittent classes to increase knowledge and influence attitudes about physical activity, nutrition, and diabetes, and some involvement of the parents. Elementary and middle schools will be randomly assigned to the intervention or control group. Participants will be 3939 youth with parental consent and personal assent. Data will be collected at baseline and annually for four more years. A subset of youth at greatest risk for T2D (body mass index equal to or > 85th percentile of national norms and T2D in first or second degree relatives and fast insulin equal to or > 25 micrograms/ml) from both groups will receive an oral glucose tolerance test. All data will be collected at the study schools. The primary outcome of the study will be the development of T2D (fasting glucose equal to or > 126 mg/dl) or impaired fasting glucose (fasting blood glucose 110 -125 mg/d). We hypothesize that, as compared with children in the control schools, fewer youth in the intervention schools will develop T2D or impaired fasting glucose. Secondary outcomes of interest that also will be addressed by the proposed study include: 1) Insulin resistance, determined with a combination of factors that will include high fasting serum insulin levels, insulin sensitivity index, acanthosis nigricans, hypertension, specific dyslipidemias (low high density lipoproteins [HDL-C] and high triglycerides [TG]); 2) General obesity (body mass index and sum of skinfolds); 3) Central obesity (waist and hip circumferences; 4) Aerobic power (V02max.); 5) Health Behaviors, specifically, physical activity and eating habits; and 6) health knowledge about ways to prevent T2DM. We hypothesize that, as compared with children in the control schools, fewer children receiving the intervention will exhibit insulin resistance, fewer children will show general and central obesity, and more children will have improved their aerobic power (pVO2), physical activity, eating habits, and health knowledge. Since the proposed study is a cooperative agreement involving multiple sites, the actual aims, variables and procedures will most likely be modified during the initial planning year.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK061223-06
Application #
7227499
Study Section
Special Emphasis Panel (ZDK1-GRB-B (O1))
Program Officer
Linder, Barbara
Project Start
2002-03-15
Project End
2009-02-28
Budget Start
2007-03-01
Budget End
2008-02-29
Support Year
6
Fiscal Year
2007
Total Cost
$2,220,173
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Type
Schools of Nursing
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Jago, R; Drews, K L; Otvos, J D et al. (2016) Novel measures of inflammation and insulin resistance are related to obesity and fitness in a diverse sample of 11-14 year olds: The HEALTHY Study. Int J Obes (Lond) 40:1157-63
Bauer, K W; Marcus, M D; El ghormli, L et al. (2015) Cardio-metabolic risk screening among adolescents: understanding the utility of body mass index, waist circumference and waist to height ratio. Pediatr Obes 10:329-37
Hernandez, Arthur E; Marcus, Marsha D; Hirst, Kathryn et al. (2014) Impact of implementation and conduct of the HEALTHY primary prevention trial on student performance. Am J Health Promot 29:55-8
Marcus, Marsha D; Foster, Gary D; El Ghormli, Laure (2014) Stability of relative weight category and cardiometabolic risk factors among moderately and severely obese middle school youth. Obesity (Silver Spring) 22:1118-25
Jago, Russell; Drews, Kimberly L; Otvos, James D et al. (2014) Effect of relative weight group change on nuclear magnetic resonance spectroscopy derived lipoprotein particle size and concentrations among adolescents. J Pediatr 164:1091-1098.e3
Hall, William J; Schneider, Margaret; Thompson, Deborah et al. (2014) School factors as barriers to and facilitators of a preventive intervention for pediatric type 2 diabetes. Transl Behav Med 4:131-40
Volpe, S L; Hall, W J; Steckler, A et al. (2013) Process evaluation results from the HEALTHY nutrition intervention to modify the total school food environment. Health Educ Res 28:970-8
Jago, Russell; Drews, Kimberly L; McMurray, Robert G et al. (2013) BMI change, fitness change and cardiometabolic risk factors among 8th grade youth. Pediatr Exerc Sci 25:52-68
Jago, R; Mendoza, J A; Chen, T et al. (2013) Longitudinal associations between BMI, waist circumference, and cardiometabolic risk in US youth: monitoring implications. Obesity (Silver Spring) 21:E271-9
Schneider, Margaret; DeBar, Lynn; Calingo, Ashley et al. (2013) The effect of a communications campaign on middle school students' nutrition and physical activity: results of the HEALTHY study. J Health Commun 18:649-67

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