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Randomized Controlled Trial
. 2012 Aug;33(4):209-22.
doi: 10.1007/s10935-012-0276-x.

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

Jeffrey A Henderson  1 , Jessica Chubak, Joan O'Connell, Maria C Ramos, Julie Jensen, Jared B Jobe; LOWPK Project Team
Affiliations
Randomized Controlled Trial

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

Jeffrey A Henderson et al. J Prim Prev. 2012 Aug.

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.

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Figures

Fig. 1
Fig. 1
Overview of the LOWPK study design
Fig. 2
Fig. 2
Flowchart of the LOWPK trial enrollment procedure
See this image and copyright information in PMC

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