Skip to main content

Advertisement

SpringerLink
Log in

Design of a Randomized Controlled Trial of a Web-Based Intervention to Reduce Cardiovascular Disease Risk Factors Among Remote Reservation–Dwelling American Indian Adults with Type 2 Diabetes

  • Research Methods and Practice
  • Published:
The Journal of Primary Prevention Aims and scope Submit manuscript

Abstract

We describe a randomized controlled trial, the Lakota Oyate Wicozani Pi Kte (LOWPK) trial, which was designed to determine whether a Web-based diabetes and nutritional intervention can improve risk factors related to cardiovascular disease (CVD) among a group of remote reservation–dwelling adult American Indian men and women with type 2 diabetes who are at high risk for CVD. Enrollment on a rolling basis of 180 planned participants began during 2009; an average 18-month follow-up was completed by June 2011. The primary outcome variable is change in glycosylated hemoglobin level after an average 18-month follow-up period. Secondary outcome variables include changes in low-density lipoprotein cholesterol, systolic blood pressure, body mass index, and smoking status, as well as an evaluation of intervention cost-effectiveness. If effective, the LOWPK trial may serve as a guide for future chronic disease intervention trials in remote, technologically challenged settings.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

References

  • Borushek, A. (2005). The Calorie King ® calorie, fat & carbohydrate counter. Costa Mesa, CA: Family Health Publications.

    Google Scholar 

  • Brazier, J. E., & Roberts, J. (2004). The estimation of a preference-based measure of health from the SF-12. Medical Care, 42, 851–859.

    Article  PubMed  Google Scholar 

  • CDC Diabetes Cost-Effectiveness Group. (2002). Cost-effectiveness of intensive glycemic control, intensified hypertension control, and serum cholesterol level reduction for type 2 diabetes. Journal of the American Medical Association, 287, 2542–2551.

    Article  Google Scholar 

  • Centers for Disease Control and Prevention. (1998). Tobacco use among U.S. racial/ethnic minority groups, African Americans, American Indians and Alaska Natives, Asian Americans and Pacific Islanders, Hispanics: A report of the Surgeon General (Executive summary). Morbidity and Mortality Weekly Report, 47(No. RR-18), v–xv, 1–16.

  • Centers for Disease Control and Prevention. (2001). Cigarette smoking among adults—United States, 1999. Morbidity and Mortality Weekly Report, 50, 869–873.

    Google Scholar 

  • Centers for Disease Control and Prevention. (2004). Disparities in premature deaths from heart disease—50 States and the District of Columbia, 2001. Morbidity and Mortality Weekly Report, 53, 121–125.

    Google Scholar 

  • Clark, N. M., & Dodge, J. A. (1999). Exploring self-efficacy as a predictor of disease management. Health Education & Behavior, 26, 72–89.

    Article  CAS  Google Scholar 

  • Clark, N. M., & Zimmerman, B. J. (1990). A social cognitive view of self-regulated learning about health. Health Education Research, 5, 371–379.

    Article  Google Scholar 

  • Committee on Quality of Health Care in America, Institute of Medicine. (2001). Crossing the quality chasm: A new health system for the 21 st century. Washington, DC: The National Academies Press.

    Google Scholar 

  • Davis, C. E., Hunsberger, S., Murray, D. M., Fabsitz, R. R., Himes, J. H., Stephenson, L. K., et al. (1999). Design and statistical analysis for the Pathways Study. American Journal of Clinical Nutrition, 69(4 Suppl), 760S–763S.

    PubMed  CAS  Google Scholar 

  • Gaede, P., Vedel, P., Larsen, N., Jensen, G. V., Parving, H. H., & Pedersen, O. (2003). Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. New England Journal of Medicine, 348, 383–393.

    Article  PubMed  Google Scholar 

  • Galloway, J. M. (2005). Cardiovascular health among American Indians and Alaska Natives: Successes, challenges, and potentials. American Journal of Preventive Medicine, 29(5 Suppl 1), 11–17.

    Article  PubMed  Google Scholar 

  • Gold, M. R., Siegel, J. E., Russell, L. B., & Weinstein, M. C. (Eds.). (1996). Cost-effectiveness in health and medicine. New York, NY: Oxford University Press.

    Google Scholar 

  • Goldberg, H. I., Lessler, D. S., Mertens, K., Eytan, T. A., & Cheadle, A. D. (2004). Self-management support in a web-based medical record: A pilot randomized controlled trial. Joint Commission Journal on Quality and Patient Safety, 30, 629–635. 589.

    Google Scholar 

  • Goldberg, H. I., Ralston, J. D., Hirsch, I. B., Hoath, J. I., & Ahmed, K. I. (2003). Using an internet comanagement module to improve the quality of chronic disease care. Joint Commission Journal on Quality and Patient Safety, 29, 443–451.

    Google Scholar 

  • Haddix, A. C., Teutsch, S. M., & Corso, P. S. (Eds.). (2002). Prevention effectiveness: A guide to decision analysis and economic evaluation. New York, NY: Oxford University Press.

    Google Scholar 

  • Howard, B. V., Lee, E. T., Cowan, L. D., Devereux, D. B., Galloway, J. M., Go, O. T., et al. (1999). Rising tide of cardiovascular disease in American Indians: The Strong Heart Study. Circulation, 99, 2389–2395.

    Article  PubMed  CAS  Google Scholar 

  • Indian Appropriations Act of March 2, 1889, 25 U. S. C. § 888 (1889).

  • Indian Health Service. (2000). Trends in Indian health 1998–1999. Rockville, MD: Office of Public Health, U.S. Department of Human Health and Services.

    Google Scholar 

  • Lee, E. T., Howard, B. V., Go, O., Savage, P. J., Fabsitz, R. R., Robbins, D. C., et al. (2000). Prevalence of undiagnosed diabetes in three American Indian populations. A comparison of the 1997 American Diabetes Association diagnostic criteria and the 1985 World Health Organization diagnostic criteria: The Strong Heart Study. Diabetes Care, 23, 181–186.

    Article  PubMed  CAS  Google Scholar 

  • Lee, E. T., Howard, B. V., Savage, P. J., Cowan, L. D., Fabsitz, R. R., Oopik, A. J., et al. (1995). Diabetes and impaired glucose tolerance in three American Indian populations aged 45–74 years: The Strong Heart Study. Diabetes Care, 18, 599–610.

    Article  PubMed  CAS  Google Scholar 

  • Lee, E. T., Welty, T. K., Cowan, L. D., Wang, W., Rhoades, D. A., Devereux, R., et al. (2002). Incidence of diabetes in American Indians of three geographic areas: The Strong Heart Study. Diabetes Care, 25, 49–54.

    Article  PubMed  Google Scholar 

  • Lee, E. T., Welty, T. K., Fabsitz, R., Cowan, L. D., Le, N. A., Oopik, A. J., et al. (1990). The Strong Heart Study: A study of cardiovascular disease in American Indians: Design and methods. American Journal of Epidemiology, 132, 1141–1155.

    PubMed  CAS  Google Scholar 

  • National Center for Health Statistics. (1994). Plan and operation of the third national health and nutrition examination survey, 1988–1994. Hyattsville, MD: US Department of Health and Human Services. DHHS Publication No. 94–1308.

    Google Scholar 

  • Nez Henderson, P., Jacobsen, C., Beals, J., & AI-SUPERPFP Team. (2005). Correlates of cigarette smoking among selected Southwest and Northern plains tribal groups: The AI-SUPERPFP Study. American Journal of Public Health, 95, 867–872.

    Article  PubMed  Google Scholar 

  • O’Connell, J. M., Brunson, D., Anselmo, T., & Sullivan, P. W. (2005). Costs and savings associated with community water fluoridation programs in Colorado. Preventing Chronic Disease, 2(Special Issue), A06.

    PubMed  Google Scholar 

  • Palmer, A. J., Roze, S., Valentine, W. J., Spinas, G. A., Shaw, J. E., & Zimmet, P. Z. (2004). Intensive lifestyle changes or metformin in patients with impaired glucose tolerance: Modeling the long-term health economic implications of the Diabetes Prevention Program in Australia, France, Germany, Switzerland, and the United Kingdom. Clinical Therapeutics, 26, 304–321.

    Article  PubMed  Google Scholar 

  • Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1, 385–401.

    Article  Google Scholar 

  • Rothman, R. L., Malone, R., Bryant, B., Shintani, A. K., Crigler, B., Dewalt, D. A., et al. (2005). A randomized trial of a primary care-based disease management program to improve cardiovascular risk factors and glycated hemoglobin levels in patients with diabetes. American Journal of Medicine, 118, 276–284.

    Article  PubMed  Google Scholar 

  • Selvin, E., Marinopoulos, S., Berkenblit, G., Rami, T., Brancati, F. L., Powe, N. R., et al. (2004). Meta-analysis: Glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Annals of Internal Medicine, 141, 421–431.

    PubMed  CAS  Google Scholar 

  • Slattery, M. L., Schumacher, M. C., Lanier, A. P., Edwards, S., Edwards, R., Murtaugh, M. A., et al. (2007). A prospective cohort of American Indian and Alaska Native people: Study design, methods, and implementation. American Journal of Epidemiology, 166, 606–615.

    Article  PubMed  CAS  Google Scholar 

  • Sullivan, S. D., Buist, A. S., & Weiss, K. (2003). Health outcomes assessment and economic evaluation in COPD: Challenges and opportunities. The European Respiratory Journal Supplement, 41, 1s–3s.

    Article  PubMed  CAS  Google Scholar 

  • Teufel-Shone, N. I., Fitzgerald, C., Teufel-Shone, L., & Gamber, M. (2009). Systematic review of physical activity interventions implemented with American Indian and Alaska Native populations in the United States and Canada. American Journal of Health Promotion, 23, S8–S32.

    Article  PubMed  Google Scholar 

  • Tworoger, S. S., Yasui, Y., Chang, L., Stanczyk, F. Z., & McTiernan, A. (2004). Specimen allocation in longitudinal biomarker studies: Controlling subject-specific effects by design. Cancer Epidemiology, Biomarkers and Prevention, 13, 1257–1260.

    Article  PubMed  Google Scholar 

  • Wagner, E. H., Sandhu, N., Newton, K. M., McCulloch, D. K., Ramsey, S. D., & Grothaus, L. C. (2001). Effect of improved glycemic control on health care costs and utilization. Journal of the American Medical Association, 285, 182–189.

    Article  PubMed  CAS  Google Scholar 

  • Ware, J., Jr., Kosinski, M., & Keller, S. D. (1996). A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care, 34, 220–233.

    Article  PubMed  Google Scholar 

  • Welty, T. K., Lee, E. T., Yeh, J., Cowan, L. D., Go, O., Fabsitz, R. R., et al. (1995). Cardiovascular disease risk factors among American Indians: The Strong Heart Study. American Journal of Epidemiology, 142, 269–287.

    PubMed  CAS  Google Scholar 

  • Welty, T. K., Rhoades, D. A., Yeh, F., Lee, E. T., Cowan, L. D., Fabsitz, R. R., et al. (2002). Changes in cardiovascular disease risk factors among American Indians: The Strong Heart Study. Annals of Epidemiology, 12, 97–106.

    Article  PubMed  Google Scholar 

  • Zhang, P., Engelgau, M. M., Norris, S. L., Gregg, E. W., & Narayan, K. M. (2004). Application of economic analysis to diabetes and diabetes care. Annals of Internal Medicine, 140, 972–977.

    PubMed  Google Scholar 

Download references

Acknowledgments

The Lakota Oyate Wicozani Pi Kte study was funded by the National Heart, Lung, and Blood Institute (UO1 HL087422). The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official view of the National Heart, Lung, and Blood Institute. We acknowledge the contributions and support of the Indian Health Service, the Cheyenne River Sioux Tribe; staff of the University of Washington, including Corinne Hunt, Phu T. Van, Andrew Bogart, Carolyn Noonan, and Odile Lallemand; Dorene Levie and Khazi Ahmed of NuMedics, Inc.; staff associated with the Black Hills Center for American Indian Health, including Monique Giago, Stephanie Big Crow and Crissy Whitewolf; and staff of Missouri Breaks Industries Research, Inc., including Marcia O’Leary, Kendra Enright, Anne Chasing Hawk, Marie Gross, Jay Kunf, and Lillian Brown. We also acknowledge Lifescan, Inc., who provided replacement One Touch Ultra glucometer devices and USB cables (to connect the glucometers to participant computers) to the study at no cost.

Author information

Author notes

  1. Jared B. Jobe

    Present address: Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA

Authors and Affiliations

  1. Black Hills Center for American Indian Health, 701 St. Joseph St., Suite 204, Rapid City, SD, 57701, USA

    Jeffrey A. Henderson, Maria C. Ramos & Julie Jensen

  2. Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD, USA

    Jared B. Jobe

  3. Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA, USA

    Jessica Chubak

  4. Department of Community and Behavioral Health, Colorado School of Public Health, University of Colorado Denver, Aurora, CO, USA

    Joan O’Connell

Authors
  1. Jeffrey A. Henderson
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jessica Chubak
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Joan O’Connell
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Maria C. Ramos
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Julie Jensen
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Jared B. Jobe
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

On Behalf of the LOWPK Project Team

Corresponding author

Correspondence to Jeffrey A. Henderson.

Additional information

Disclaimer: The opinions expressed in this paper are those of the author(s) and do not necessarily reflect the views of the Indian Health Service or National Heart, Lung and Blood Institute.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Henderson, J.A., Chubak, J., O’Connell, J. et al. Design of a Randomized Controlled Trial of a Web-Based Intervention to Reduce Cardiovascular Disease Risk Factors Among Remote Reservation–Dwelling American Indian Adults with Type 2 Diabetes. J Primary Prevent 33, 209–222 (2012). https://doi.org/10.1007/s10935-012-0276-x

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10935-012-0276-x

Keywords

Search

Navigation