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Behavioral Treatment of High Blood Pressure

This study is an NIH-funded clinical trial conducted at Duke Medical Center evaluating the effects of the DASH diet alone and combined with a behavioral weight loss program on blood pressure and various vascular measures. Eligible patients must be unmedicated with blood pressure values ranging from approximately 130/85 to 159/99. Our primary hypothesis are as follows: (1) The DASH diet alone and combined with a behavioral weight management program will result in greater BP reductions than Usual Care controls at the end of the 4 month treatment period; (2) The DASH diet in combination with a behavioral weight management program will be more effective in lowering BP than the DASH diet alone; (3) The DASH diet alone and the DASH diet combined with the behavioral weight management program will result in greater improvements in cardiac, metabolic, and vascular function compared to the control condition; and (4) The combined DASH diet and weight management intervention also will be the most effective treatment in maintaining BP reductions at 1-year follow-up.

Description

The present application seeks to extend previous findings by a) evaluating the efficacy of the DASH diet in a free-living situation; (b) considering the DASH diet alone and in combination with a behavioral weight loss program including aerobic exercise; (c) examining the impact of diet and exercise on cardiac, metabolic, and vascular function, including measures of arterial stiffness, endothelial function, baroreflex control, body composition, insulin resistance, cardiac hemodynamics, and left ventricular (LV) geometry and mass; and (d) following patients for one year to determine the longer term impact of the interventions on BP, body weight, and cardiovascular function.

Status: Active, not recruiting (N/A). Started on October 1st, 2003. Ended on June 1st, 2009.

Enrollment: 150 subjects

Study Type: Interventional

Study Design:

  • Treatment
  • Randomized
  • Single Blind (Outcomes Assessor)
  • Parallel Assignment
  • Efficacy Study

Conditions:

Interventions:

  • Behavioral: DASH diet
  • Behavioral: DASH diet plus Weight loss

Eligibility

Inclusion Criteria:

  1. Baseline SBP 130-159 mmHg (+/- 2mmHg) or DBP 85-99 mmHg (+/- 2 mm Hg)

  2. Age 35 years or older

  3. BMI 25.0-39.99 kg/m��, with a maximum weight of 300 lbs

  4. Willing and able to participate fully in all aspects of the intervention

  5. Must currently be sedentary (less than 3x/wk for 30 mins each time)

  6. Informed consent

Exclusion Criteria:

  1. Use of weight-loss medication and/or participation in a structured weight-loss program in the 3 months prior to 1st screening visit.

  2. Regular use of an anti-hypertensive drug or other drugs that raise or lower BP and if discontinued use, must be off for 1 month before screening

  3. Current use of insulin or oral hypoglycemic agents

  4. Current use of medications for treatment of psychosis or manic-depressive illness.

  5. ADHD medications (Ritalin/Aderol/amphetamines

  6. Cardiovascular Event

  7. Coronary Artery Disease

  8. Congestive Heart Failure

  9. Current symptoms of Angina for peripheral vascular disease

    1. Cancer diagnosis (except for non-melanoma skin cancer) or treatment in past 2 years

    2. Fasting blood sugar >126 mg/dl

    3. Gastric Bypass/Bariatric Surgery

    4. Pyschiatric hospitalization in the past 2 years.

    5. Unable or willing to consume all of the dietary foods provided during the 2-week feeding.

    6. Consumption of more than 21 alcoholic drinks per week or binge drinking

    7. Alcoholism as determined by the Alcohol AUDIT (screening questionnaires)

    8. Planning to leave the area prior to the anticipated end of participation

    9. Body weight change of >15lbs in the 3 months prior to the 1st screening visit

    10. Pregnant, breast feeding, or planning pregnancy prior to end of participation

    11. Current participation in another clinical trial until after completion of T2

    12. Investigator discretion for safety or adherence reasons

    13. Controlled substance abuse

Gender

Both

Mininum Age

35 Years

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers

Resources

Source: Duke University

Authority: United States: Institutional Review Board

Locations

  • Duke University
    Durham
    North Carolina
    27710
    United States

Officials

  • James A. Blumenthal, Ph.D. (Principal Investigator, Duke University)

Sponsors

  • Duke University (Lead Sponsor)

  • National Heart, Lung, and Blood Institute (NHLBI) (Collaborator)

References

  • Svetkey LP, Harsha DW, Vollmer WM, Stevens VJ, Obarzanek E, Elmer PJ, Lin PH, Champagne C, Simons-Morton DG, Aickin M, Proschan MA, Appel LJ. Premier: a clinical trial of comprehensive lifestyle modification for blood pressure control: rationale, design and baseline characteristics. Ann Epidemiol. 2003 Jul;13(6):462-71.
    PMID: 12875806.
    Check for Full Text

  • [No authors listed] The sixth report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Arch Intern Med. 1997 Nov 24;157(21):2413-46. Erratum in: Arch Intern Med 1998 Mar 23;158(6):573.
    PMID: 9385294.
    Check for Full Text

  • Blumenthal JA, Sherwood A, Gullette EC, Babyak M, Waugh R, Georgiades A, Craighead LW, Tweedy D, Feinglos M, Appelbaum M, Hayano J, Hinderliter A. Exercise and weight loss reduce blood pressure in men and women with mild hypertension: effects on cardiovascular, metabolic, and hemodynamic functioning. Arch Intern Med. 2000 Jul 10;160(13):1947-58.
    PMID: 10888969.
    Check for Full Text

  • Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10.
    PMID: 11136953.
    Check for Full Text

  • Blumenthal JA, Sherwood A, Gullette EC, Georgiades A, Tweedy D. Biobehavioral approaches to the treatment of essential hypertension. J Consult Clin Psychol. 2002 Jun;70(3):569-89. Review.
    PMID: 12090370.
    Check for Full Text

  • Linden W, Chambers L. Clinical effectiveness of non-drug treatment for hypertension: a meta-analysis. Ann Behav Med. 16:35-45, 1994.

  • Windhauser MM, Evans MA, McCullough ML, Swain JF, Lin PH, Hoben KP, Plaisted CS, Karanja NM, Vollmer WM. Dietary adherence in the Dietary Approaches to Stop Hypertension trial. DASH Collaborative Research Group. J Am Diet Assoc. 1999 Aug;99(8 Suppl):S76-83.
    PMID: 10450298.
    Check for Full Text

  • Svetkey LP, Simons-Morton D, Vollmer WM, Appel LJ, Conlin PR, Ryan DH, Ard J, Kennedy BM. Effects of dietary patterns on blood pressure: subgroup analysis of the Dietary Approaches to Stop Hypertension (DASH) randomized clinical trial. Arch Intern Med. 1999 Feb 8;159(3):285-93.
    PMID: 9989541.
    Check for Full Text

  • Hinderliter A, Sherwood A, Gullette EC, Babyak M, Waugh R, Georgiades A, Blumenthal JA. Reduction of left ventricular hypertrophy after exercise and weight loss in overweight patients with mild hypertension. Arch Intern Med. 2002 Jun 24;162(12):1333-9.
    PMID: 12076231.
    Check for Full Text

  • Blumenthal JA, Siegel WC, Appelbaum M. Failure of exercise to reduce blood pressure in patients with mild hypertension. Results of a randomized controlled trial. JAMA. 1991 Oct 16;266(15):2098-104.
    PMID: 1920698.
    Check for Full Text

Links

None.

Date Verified
August 1st, 2008
First Received
August 13th, 2008
Last Changed
August 13th, 2008

Information obtained from ClinicalTrials.gov on August 15, 2008. Link to the current ClinicalTrials.gov record.

All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.

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