Current Diabetes Reports

, Volume 13, Issue 1, pp 63–71 | Cite as

Lessons Learned From the HEALTHY Primary Prevention Trial of Risk Factors for Type 2 Diabetes in Middle School Youth

  • Marsha D. Marcus
  • Kathryn Hirst
  • Francine Kaufman
  • Gary D. Foster
  • Tom Baranowski
Pediatric Type 2 Diabetes (PS Zeitler, Section Editor)

Abstract

The HEALTHY trial was designed to take a primary prevention approach to risk factors for type 2 diabetes in youth, primarily obesity. The study involved over 6,000 students at 42 middle schools across the U.S. Half received an integrated intervention program of components addressing the school food environment, physical education, lifestyle behaviors, and promotional messaging. The intervention was designed to be more comprehensive than previous efforts, and the research was amply funded. Although the primary objective of reducing the percentage of overweight and obesity in schools that received the intervention program, as compared with control schools, was not obtained, key secondary outcomes indicated an intervention effect. In retrospect, senior investigators involved in the study’s design, conduct, and analysis discuss weaknesses and strengths and offer recommendations for future research efforts that address prevention of childhood obesity from a public health perspective.

Keywords

Obesity Metabolic risk Cardiovascular risk Prevention School-based health promotion Preadolescence Cluster design trial Diabetes HEALTHY 

Notes

Acknowledgments

We wish to thank the administration, faculty, staff, students, and their families at the middle schools and school districts that participated in the HEALTHY study.

This work was completed with funding from NIDDK/NIH Grants U01-DK61230, U01-DK61249, U01-DK61231, and U01-DK61223, with additional support from the American Diabetes Association.

HEALTHY intervention materials are available for download at http://www.healthystudy.org/.

Disclosure

Conflicts of interest: M.D. Marcus has received a subcontract from George Washington University (part of a Cooperative agreement from NIDDK) and has been on the Scientific Advisory Board for United Health Care. K. Hirst has received grant support from NIDDK; also, travel to study meetings was covered; the NIDDK grant covered all activity, including committee work and data analysis, but not under a fee but under a cost-reimbursable grant. F. Kaufman has received grant support from NIDDK; also, travel to study meetings was covered. G.D. Foster has received grant support from NIH/NIDDK; also, travel to study meetings was covered; he has received salary support from a grant and has been on the Scientific Advisory Board for United Health Group, ConAgra Food, Tate and Lyle. T. Baranowski received grant support from NIDDK; also, travel to study meetings was covered; he also serves on the Publications and Presentations Committee for the HEALTHY trial (NIDDK).

References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of outstanding importance

  1. 1.
    Ogden CL, Carroll MD, Curtin LR, et al. Prevalence of high body mass index in US children and adolescents, 2007-2008. JAMA. 2010;303:242–9.PubMedCrossRefGoogle Scholar
  2. 2.
    • Weiss MD, Dziura J, Burgert TS, et al. Obesity and the metabolic syndrome in children and adolescents. N Engl J Med. 2004;350:2362–74. Documentation of cardiometabolic risk associated with childhood obesity. Provides compelling support for prevention and treatment programs..PubMedCrossRefGoogle Scholar
  3. 3.
    Story M. School-based approaches for preventing and treating obesity. Int J Obes. 1999;23:S43–51.CrossRefGoogle Scholar
  4. 4.
    American Academy of Pediatrics. Physical fitness and activity in schools. Pediatrics. 2000;105:1156.CrossRefGoogle Scholar
  5. 5.
    National Center for Chronic Disease Prevention and Health Promotion. Guidelines for school and community programs to promote lifelong physical activity among young people. J Sch Heal. 1997;67:202–19.CrossRefGoogle Scholar
  6. 6.
    •• Summerbell CD, Waters E, Edmunds LD, et al. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2005;3:1–70. A systematic review of childhood obesity prevention studies that places the current manuscript in the context of existing literature..Google Scholar
  7. 7.
    •• HEALTHY Study Group. A school-based intervention for diabetes risk reduction. N Engl J Med. 2010;363:443–53. The primary findings of the HEALTHY primary prevention trial..CrossRefGoogle Scholar
  8. 8.
    • HEALTHY Study Group. HEALTHY study rationale, design and methods: moderating risk of type 2 diabetes in multi-ethnic middle school students. Int J Obes. 2009;33:S4–S20. In-depth presentation of the design of HEALTHY for those desiring more detailed information..Google Scholar
  9. 9.
    Drews KL, Harrell JS, Thompson D, et al. Recruitment and retention strategies and methods in the HEALTHY study. Int J Obes. 2009;33:S21–8.CrossRefGoogle Scholar
  10. 10.
    Gillis B, Mobley C, Stadler DD, et al. Rationale, design and methods of the HEALTHY study nutrition intervention component. Int J Obes. 2009;33:S29–36.CrossRefGoogle Scholar
  11. 11.
    McMurray RG, Bassin S, Jago R, et al. Rationale, design and methods of the HEALTHY study physical education intervention component. Int J Obes. 2009;33:S37–43.CrossRefGoogle Scholar
  12. 12.
    Venditti EM, Elliot DL, Faith MS, et al. Rationale, design and methods of the HEALTHY study behavior intervention component. Int J Obes. 2009;33:S44–51.CrossRefGoogle Scholar
  13. 13.
    DeBar LL, Schneider M, Ford EG, et al. Social marketing-based communications to integrate and support the HEALTHY study intervention. Int J Obes. 2009;33:S52–9.CrossRefGoogle Scholar
  14. 14.
    Schneider M, Hall WJ, Hernandez AE, et al. Rationale, design and methods for process evaluation in the HEALTHY study. Int J Obes. 2009;33:S60–7.CrossRefGoogle Scholar
  15. 15.
    Weigensberg MJ, Ball GD, Shaibi GQ, et al. Decreased B-cell function in overweight Latino children with impaired fasting glucose. Diabetes Care. 2005;28:2519–24.PubMedCrossRefGoogle Scholar
  16. 16.
    Nathan DM, Davidson MB, DeFronzo RA, et al. Impaired fasting glucose and impaired glucose tolerance. Diabetes Care. 2007;30:253–9.Google Scholar
  17. 17.
    Weiss R, Taksali SE, Tamborlane WV, et al. Predictors of changes in glucose tolerance status in obese youth. Diabetes Care. 2005;28:902–9.PubMedCrossRefGoogle Scholar
  18. 18.
    Ford ES, Li C, Imperatore G, Cook S. Age, sex, and ethnic variations in serum insulin concentrations among US youth. Diabetes Care. 2006;29:2605–11.PubMedCrossRefGoogle Scholar
  19. 19.
    Goran MI, Gower BA. Longitudinal study on pubertal insulin resistance. Diabetes. 2001;50:2444–50.PubMedCrossRefGoogle Scholar
  20. 20.
    Duncan GE, Li SM, Zhou XH. Prevalence and trends of a metabolic syndrome phenotype among US adolescents, 1999-2000. Diabetes Care. 2004;27:2438–43.PubMedCrossRefGoogle Scholar
  21. 21.
    Viner RM, Segal TY, Lichtarowicz K, Hindmarsh P. Prevalence of insulin resistance syndrome in obesity. Arch Dis. 2005;90:10–4.CrossRefGoogle Scholar
  22. 22.
    McKenzie TL, Catellier DJ, Conway T, et al. Girls' activity levels and lesson contexts in middle school PE – TAAG baseline. Med Sci Sports Exerc. 2006;38:1229–35.PubMedCrossRefGoogle Scholar
  23. 23.
    Fairclough S, Stratton G. Physical activity levels in middle and high school physical education – a review. Ped Exerc Sci. 2005;17:217–36.Google Scholar
  24. 24.
    McKenzie TL, Stone EJ, Feldman HA, et al. Effects of the CATCH physical education intervention teacher types and lesson location. Am J Prev Med. 2001;21:101–9.PubMedCrossRefGoogle Scholar
  25. 25.
    Van Beurden E, Barnett LM, Zask A, et al. Can we skill and activate children through primary school physical education lessons? "Move it, Groove it" – a collaborative health promotion intervention. Prev Med. 2003;36:493–501.PubMedCrossRefGoogle Scholar
  26. 26.
    McKenzie TL, Sallis JF, Prochaska JJ, et al. Evaluation of a two-year middle school physical education intervention – MSPAN. Med Sci Sports Exerc. 2004;36:1382–8.PubMedCrossRefGoogle Scholar
  27. 27.
    Gutin B, Cucuzzo N, Islam S, et al. Physical training, lifestyle education, and coronary risk factors in obese girls. Med Sci Sports Exerc. 1996;28:19–23.PubMedGoogle Scholar
  28. 28.
    McMurray RG, Bauman MJ, Harrell JS, et al. Effects of improvement in aerobic power on resting insulin and glucose concentrations in children. Eur J Appl Physiol. 2000;81:132–9.PubMedCrossRefGoogle Scholar
  29. 29.
    Hall WJ, Zeveloff A, Steckler A, et al. Process evaluation results from the HEALTHY physical education intervention. Heal Educ Res. 2011. doi:10.1093/her/cyr107.
  30. 30.
    Schneider M, DeBar L, Calingo A, et al. The effect of a communications campaign on middle school students’ nutrition and physical activity: results of the HEALTHY study. Journal of Health Communications. in press.Google Scholar
  31. 31.
    • Marcus MD, Foster GD, El Ghormli L, et al. Shifts in BMI category and associated cardiometabolic risk: prospective results from HEALTHY study. Pediatrics. 2012;129:e983. doi:10.1542/peds.2011-2696. Specific information about changes in cardiometabolic risk in the HEALTHY cohort..PubMedCrossRefGoogle Scholar
  32. 32.
    Siega-Riz AM, El Ghormli L, Mobley C, et al. The effects of the HEALTHY study intervention on middle school student dietary intakes. International Journal of Behavioral Nutrition and Physical Activity 2011;8:7, http://www.ijbnpa.org/content/8/1/7.
  33. 33.
    Jago R, McMurray RG, Drews KL, et al. HEALTHY intervention – fitness, physical activity and metabolic syndrome results. Med Sci Sports Exerc. 2011;43:1513–22.PubMedCrossRefGoogle Scholar
  34. 34.
    Hill RJ, Davies PS. The validity of self-reported energy intake as determined using the doubly labeled water technique. Br J Nutr. 2001;85:415–30.PubMedCrossRefGoogle Scholar
  35. 35.
    Moore JB, Hanes Jr JC, Barbeau P, et al. Validation of the physical activity questionnaire for older children in children of different races. Pediatr Exerc Sci. 2007;19:6–19.PubMedGoogle Scholar
  36. 36.
    Koepp GA, Snedden BJ, Flynn L, et al. Feasibility analysis of standing desks for sixth graders. Infant, Child, Adolescent Nutr. 2012;4:89. doi:10.1177/1941406412439414.CrossRefGoogle Scholar
  37. 37.
    O’Neill JR, Pate RR, Hooker SP. The contribution of dance to daily physical activity among adolescent girls. Int J Behav Nutr Phys Act. 2011;8:87. doi:10.1186/1479-5868-8-87.PubMedCrossRefGoogle Scholar
  38. 38.
    Mobley CC, Stadler DD, Staten MA, et al. Effect of nutrition changes on foods selected by students in a middle school-based diabetes prevention intervention program – the HEALTHY experience. J Sch Heal. 2012;82:82–90.CrossRefGoogle Scholar
  39. 39.
    Hartstein J, Cullen KW, Virus A, et al. Impact of the HEALTHY study on vending machine offerings in middle schools. Journal of Child Nutrition & Management 2011;35, http://www.schoolnutrition.org/Content.aspx?id=16353.
  40. 40.
    USDA Food and Nutrition Service. Nutrition standards in the national school lunch and school breakfast programs final rule. Fed Regist. 2012;77(17):4087–167.Google Scholar
  41. 41.
    Madsen KA. School-based body mass index screening and parent notification: a statewide natural experiment. Arch Pediatr Adolesc Med. 2011;165(11):987–92.PubMedCrossRefGoogle Scholar
  42. 42.
    Hedley AA, Ogden CL, Johnson CL, et al. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004;291:2847–50.PubMedCrossRefGoogle Scholar
  43. 43.
    Kaufman F, Hirst K, Buse J, et al. Effect of secular trends on a primary prevention trial: the HEALTHY study experience. Childhood Obesity 2011;7(4), doi: 10.1089/chi.2011.0044, http://www.liebertonline.com/doi/pdfplus/10.1089/chi.2011.0044.
  44. 44.
    von Hippel PT, Powell B, Downey DB, Rowland NJ. The effect of school on overweight in childhood: gain in body mass index during the school year and during summer vacation. Am J Public Health. 2007;97(4):696–702.CrossRefGoogle Scholar
  45. 45.
    Borradaile KE, Sherman S, Vander Veur SS, et al. Snacking in children – the role of urban corner stores. Pediatrics. 2009;124(5):1293–8.PubMedCrossRefGoogle Scholar
  46. 46.
    Levine JA, vander Weg MW, Hill JO, Klesges RC. Non-exercise activity thermogenesis – the crouching tiger hidden dragon of societal weight gain. Arterioscler Thromb Vasc Biol. 2006;26:729–36.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2012

Authors and Affiliations

  • Marsha D. Marcus
    • 1
  • Kathryn Hirst
    • 2
  • Francine Kaufman
    • 3
  • Gary D. Foster
    • 4
  • Tom Baranowski
    • 5
  1. 1.University of Pittsburgh School of MedicinePittsburghUSA
  2. 2.George Washington University Biostatistics CenterRockvilleUSA
  3. 3.Children’s Hospital Los AngelesLos AngelesUSA
  4. 4.Temple University Center for Obesity Research and EducationPhiladelphiaUSA
  5. 5.Baylor College of Medicine Children’s Nutrition Research CenterHoustonUSA

Personalised recommendations