title: 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.
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.
authors.affiliation: Black Hills Center for American Indian Health, 701 St. Joseph St., Suite 204, Rapid City, SD 57701, USA. jhenderson@bhcaih.org
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Henderson
authors.forename: Jessica
authors.initials: J
authors.lastname: Chubak
authors.forename: Joan
authors.initials: J
authors.lastname: O'Connell
authors.forename: Maria C
authors.initials: MC
authors.lastname: Ramos
authors.forename: Julie
authors.initials: J
authors.lastname: Jensen
authors.forename: Jared B
authors.initials: JB
authors.lastname: Jobe
mesh_terms: D000328:Adult; D000368:Aged; D001794:Blood Pressure; D015992:Body Mass Index; D002318:Cardiovascular Diseases / Q000208:ethnology / Q000209:etiology / Q000517:prevention & control*; D008078:Cholesterol, LDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications* / Q000208:ethnology; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006293:Health Promotion / Q000379:methods* / Q000592:standards; D006801:Humans; D007198:Indians, North American; D020407:Internet; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D016540:Smoking Cessation; D013023:South Dakota; D015431:Weight Loss; D055815:Young Adult
chemical_list: D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin