Patricia J. Elmer, PhD; Eva Obarzanek, PhD; William M. Vollmer, PhD; Denise Simons-Morton, MD, PhD; Victor J. Stevens, PhD; Deborah Rohm Young, PhD; Pao-Hwa Lin, PhD; Catherine Champagne, PhD; David W. Harsha, PhD; Laura P. Svetkey, MD; Jamy Ard, MD; Phillip J. Brantley, PhD; Michael A. Proschan, PhD; Thomas P. Erlinger, MD, MPH; Lawrence J. Appel, MD; for the PREMIER Collaborative Research Group
ClinicalTrials.gov Identifier: NCT00000616
Acknowledgments: The authors thank the PREMIER participants for their sustained commitment to the trial, the staff members from the participating sites, and the members of the trial's data and safety monitoring board.
Grant Support: By National Heart, Lung, and Blood Institute (National Institutes of Health) grants UO1 HL60570, UO1 HL60571, UO1 HL60573, UO1 HL60574, and UO1 HL62828.
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: William M. Vollmer, PhD, Center for Health Research, Kaiser Permanente Northwest, 3800 North Interstate Avenue, Portland, OR 97227; e-mail, William.Vollmer@kpchr.org.
Current Author Addresses: Dr. Elmer: 3927 NE Tillamook, Portland, OR 97212.
Drs. Obarzanek and Simons-Morton: National Heart, Lung, and Blood Institute, Division of Epidemiology and Clinical Applications, 6701 Rockledge Drive, MSC 7936, Room 8136, Bethesda, MD 20892.
Drs. Vollmer and Stevens: Center for Health Research, Kaiser Permanente Northwest, 3800 North Interstate Avenue, Portland, OR 97227.
Dr. Rohm Young: Department of Kinesiology, Room 2312, HHP Building, University of Maryland, College Park, MD 20741.
Dr. Lin: Duke University Medical Center, Box 3487, Durham, NC 27710.
Drs. Champagne and Harsha: Pennington Biomedical Research Center, Nutritional Epidemiology and Dietary Assessment and Counseling, Louisiana State University System, 6400 Perkins Road, Baton Rouge, LA 70808-4124.
Dr. Svetkey: Duke University Medical Center, Box 3075, Durham, NC 27710.
Dr. Ard: Division of Clinical Nutrition & Dietetics, University of Alabama at Birmingham, 441 Webb Nutrition Sciences Building, 1675 University Boulevard, Birmingham, AL 35294-3360.
Dr. Brantley: Behavioral Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Road, Baton Rouge, LA 70808-4124.
Dr. Proschan: National Heart, Lung, and Blood Institute, Division of Epidemiology and Clinical Applications, 6701 Rockledge Drive, MSC 7938, Bethesda, MD 20892.
Dr. Erlinger: Department of Internal Medicine, University of Texas Medical Branch, Austin, Brackenridge Hospital Annex, 0.255, 601 East 15th Street, Austin, TX 78701.
Dr. Appel: Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, 2024 East Monument Street, Suite 2-618, Baltimore, MD 21205.
Author Contributions: Conception and design: P.J. Elmer, E. Obarzanek, W.M. Vollmer, D. Simons-Morton, V.J. Stevens, D. Rohm Young, P.-H. Lin, C. Champagne, D.W. Harsha, L.P. Svetkey, P.J. Brantley, L.J. Appel.
Analysis and interpretation of the data: P.J. Elmer, E. Obarzanek, W.M. Vollmer, D. Simons-Morton, V.J. Stevens, P.-H. Lin, D.W. Harsha, L.P. Svetkey, J. Ard, L.J. Appel.
Drafting of the article: P.J. Elmer, W.M. Vollmer, V.J. Stevens, D.W. Harsha, L.P. Svetkey, L.J. Appel.
Critical revision of the article for important intellectual content: P.J. Elmer, E. Obarzanek, W.M. Vollmer, D. Simons-Morton, V.J. Stevens, D. Rohm Young, P.-H. Lin, D.W. Harsha, L.P. Svetkey, J. Ard, P.J. Brantley, M.A. Proschan, T.P. Erlinger, L.J. Appel.
Final approval of the article: P.J. Elmer, E. Obarzanek, W.M. Vollmer, D. Simons-Morton, V.J. Stevens, D. Rohm Young, D.W. Harsha, L.P. Svetkey, J. Ard, P.J. Brantley, T.P. Erlinger, L.J. Appel.
Provision of study materials or patients: P.-H. Lin, L.P. Svetkey, L.J. Appel.
Statistical expertise: W.M. Vollmer, M.A. Proschan.
Obtaining of funding: P.J. Elmer, W.M. Vollmer, V.J. Stevens, L.P. Svetkey, L.J. Appel.
Administrative, technical, or logistic support: E. Obarzanek, D. Simons-Morton, V.J. Stevens, C. Champagne.
Collection and assembly of data: V.J. Stevens, C. Champagne, L.P. Svetkey, L.J. Appel.
The main 6-month results from the PREMIER trial showed that comprehensive behavioral intervention programs improve lifestyle behaviors and lower blood pressure.
To compare the 18-month effects of 2 multicomponent behavioral interventions versus advice only on hypertension status, lifestyle changes, and blood pressure.
Multicenter, 3-arm, randomized trial conducted from January 2000 through November 2002.
4 clinical centers and a coordinating center.
810 adult volunteers with prehypertension or stage 1 hypertension (systolic blood pressure, 120 to 159 mm Hg; diastolic blood pressure, 80 to 95 mm Hg).
A multicomponent behavioral intervention that implemented long-established recommendations (“established”); a multicomponent behavioral intervention that implemented the established recommendations plus the Dietary Approaches to Stop Hypertension (DASH) diet (“established plus DASH”); and advice only.
Lifestyle variables and blood pressure status. Follow-up for blood pressure measurement at 18 months was 94%.
Compared with advice only, both behavioral interventions statistically significantly reduced weight, fat intake, and sodium intake. The established plus DASH intervention also statistically significantly increased fruit, vegetable, dairy, fiber, and mineral intakes. Relative to the advice only group, the odds ratios for hypertension at 18 months were 0.83 (95% CI, 0.67 to 1.04) for the established group and 0.77 (CI, 0.62 to 0.97) for the established plus DASH group. Although reductions in absolute blood pressure at 18 months were greater for participants in the established and the established plus DASH groups than for the advice only group, the differences were not statistically significant.
The exclusion criteria and the volunteer nature of this cohort may limit generalizability. Although blood pressure is a well-accepted risk factor for cardiovascular disease, the authors were not able to assess intervention effects on clinical cardiovascular events in this limited time and with this sample size.
Over 18 months, persons with prehypertension and stage 1 hypertension can sustain multiple lifestyle modifications that improve control of blood pressure and could reduce the risk for chronic disease.
Patricia J. Elmer, Eva Obarzanek, William M. Vollmer, Denise Simons-Morton, Victor J. Stevens, Deborah Rohm Young, et al. Effects of Comprehensive Lifestyle Modification on Diet, Weight, Physical Fitness, and Blood Pressure Control: 18-Month Results of a Randomized Trial. Ann Intern Med. 2006;144:485–495. doi: 10.7326/0003-4819-144-7-200604040-00007
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Published: Ann Intern Med. 2006;144(7):485-495.
Cardiology, Coronary Risk Factors, Hypertension, Nephrology.
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