ENCORE: Exercise and Nutritional Interventions for Cardiovascular Health

NCT00571844 | Completed DMC

• 3 other identifiers: Pro000078585R01HL0741034842
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

High Blood Pressure; Exercise; Diet; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  4 months

Secondary Outcomes (1)

• Ambulatory blood pressure,vascular function,left ventricular geometry, glucose tolerance,body composition, quality of life

  4 months

Study Arms (3)

DASH diet

EXPERIMENTAL

Behavioral: DASH diet

DASH diet plus Weight loss

EXPERIMENTAL

Behavioral: DASH diet plus Weight loss

Usual Care

NO INTERVENTION

Usual Care Control Group: Patients in the Usual Care control group will be asked to maintain their usual dietary and exercise habits for 4 months until they are re-evaluated. At biweekly intervals we will ask patients to describe any spontaneous changes in their eating habits or food preferences. To ensure patient safety, BPs will also be monitored biweekly by our staff.

Interventions

DASH diet BEHAVIORAL

Participants in the DASH diet condition receive instruction in modifying the content of their diet to meet DASH guidelines. Participants are explicitly asked not to exercise or to attempt weight loss at this time, and to focus their attention on what they eat. Following the 2-week feeding period, participants will receive instruction on the DASH diet and feedback on their adherence to the diet in a series of half-hour, weekly small group sessions (3 to 5 participants).

DASH diet

DASH diet plus Weight loss BEHAVIORAL

Participants in the DASH diet plus weight loss condition will receive the DASH dietary intervention as described in the DASH diet intervention and will participate in a program to promote weight loss consisting of 2 components: Supervised Aerobic Exercise and CBWL (Cognitive Behavioral Weight loss). During supervised exercise participants will exercise 3x/week under medical supervision at the Duke Center for Living. A trained exercise physiologist will supervise all exercise sessions, and will obtain exercise BP measurements to make sure that BP is not abnormally elevated. For the CBWL participants will meet in small groups of 3-5 patients for instruction in weight management techniques. CBWL will include Appetite Awareness Training (AAT), a self-monitoring strategy developed to provide more specific guidelines regarding how much to eat. Individuals learn to identify moderate hunger and fullness and use these internal cues to guide their eating.

DASH diet plus Weight loss

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Baseline SBP 130-159 mmHg (+/- 2mmHg) or DBP 85-99 mmHg (+/- 2 mm Hg)
• Age 35 years or older
• BMI 25.0-39.99 kg/m², with a maximum weight of 300 lbs
• Willing and able to participate fully in all aspects of the intervention
• Must currently be sedentary (less than 3x/wk for 30 mins each time)
• Informed consent

You may not qualify if:

• Use of weight-loss medication and/or participation in a structured weight- loss program in the 3 months prior to 1st screening visit.
• 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
• Current use of insulin or oral hypoglycemic agents
• Current use of medications for treatment of psychosis or manic-depressive illness.
• ADHD medications (Ritalin/Aderol/amphetamines
• Cardiovascular Event
• Coronary Artery Disease
• Congestive Heart Failure
• Current symptoms of Angina for peripheral vascular disease
• Cancer diagnosis (except for non-melanoma skin cancer) or treatment in past 2 years
• Fasting blood sugar \>126 mg/dl
• Gastric Bypass/Bariatric Surgery
• Pyschiatric hospitalization in the past 2 years.
• Unable or willing to consume all of the dietary foods provided during the 2-week feeding.
• Consumption of more than 21 alcoholic drinks per week or binge drinking

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (17)

• 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. doi: 10.1016/s1047-2797(03)00006-1.

  PMID: 12875806 BACKGROUND

• 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. doi: 10.1001/archinte.157.21.2413.

  PMID: 9385294 BACKGROUND

• 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. doi: 10.1001/archinte.160.13.1947.

  PMID: 10888969 BACKGROUND

• Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.

  PMID: 9099655 BACKGROUND

• 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; DASH-Sodium Collaborative Research Group. 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. doi: 10.1056/NEJM200101043440101.

  PMID: 11136953 BACKGROUND

• 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.

  PMID: 12090370 BACKGROUND

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

  BACKGROUND

• Jeffery RW. Weight management and hypertension. Ann Behav Med. 13:18-22, 1991.

  BACKGROUND

• 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. doi: 10.1016/s0002-8223(99)00420-4.

  PMID: 10450298 BACKGROUND

• 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. doi: 10.1001/archinte.159.3.285.

  PMID: 9989541 BACKGROUND

• 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. doi: 10.1001/archinte.162.12.1333.

  PMID: 12076231 BACKGROUND

• 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 BACKGROUND

• Hinderliter AL, Smith P, Sherwood A, Blumenthal J. Lifestyle Interventions Reduce the Need for Guideline-Directed Antihypertensive Medication. Am J Hypertens. 2021 Oct 27;34(10):1100-1107. doi: 10.1093/ajh/hpab090.

  PMID: 34107031 DERIVED

• Hinderliter AL, Sherwood A, Craighead LW, Lin PH, Watkins L, Babyak MA, Blumenthal JA. The long-term effects of lifestyle change on blood pressure: One-year follow-up of the ENCORE study. Am J Hypertens. 2014 May;27(5):734-41. doi: 10.1093/ajh/hpt183. Epub 2013 Oct 1.

  PMID: 24084586 DERIVED

• Epstein DE, Sherwood A, Smith PJ, Craighead L, Caccia C, Lin PH, Babyak MA, Johnson JJ, Hinderliter A, Blumenthal JA. Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. J Acad Nutr Diet. 2012 Nov;112(11):1763-73. doi: 10.1016/j.jand.2012.07.007. Epub 2012 Sep 19.

  PMID: 23000025 DERIVED

• Blumenthal JA, Babyak MA, Sherwood A, Craighead L, Lin PH, Johnson J, Watkins LL, Wang JT, Kuhn C, Feinglos M, Hinderliter A. Effects of the dietary approaches to stop hypertension diet alone and in combination with exercise and caloric restriction on insulin sensitivity and lipids. Hypertension. 2010 May;55(5):1199-205. doi: 10.1161/HYPERTENSIONAHA.109.149153. Epub 2010 Mar 8.

  PMID: 20212264 DERIVED

• Blumenthal JA, Babyak MA, Hinderliter A, Watkins LL, Craighead L, Lin PH, Caccia C, Johnson J, Waugh R, Sherwood A. Effects of the DASH diet alone and in combination with exercise and weight loss on blood pressure and cardiovascular biomarkers in men and women with high blood pressure: the ENCORE study. Arch Intern Med. 2010 Jan 25;170(2):126-35. doi: 10.1001/archinternmed.2009.470.

  PMID: 20101007 DERIVED

MeSH Terms

Conditions

Hypertension; Motor Activity

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• James A. Blumenthal, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 12, 2007
• Study Start: October 1, 2003
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2013
• Last Updated: July 14, 2014

Record last verified: 2013-11

Locations

US (1)