HypertensionENCORENCT00571844
ENCORE: Exercise and Nutritional Interventions for Cardiovascular Health
A study testing DASH diet and DASH diet plus Weight loss in people with Hypertension, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- DASH diet and DASH diet plus Weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
- Alcoholism as determined by the Alcohol AUDIT (screening questionnaires)
- Planning to leave the area prior to the anticipated end of participation
- Body weight change of >15lbs in the 3 months prior to the 1st screening visit
- Pregnant, breast feeding, or planning pregnancy prior to end of participation
- Current participation in another clinical trial until after completion of T2
- Investigator discretion for safety or adherence reasons
- Controlled substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Hypertension
- Being tested
- DASH diet, DASH diet plus Weight loss
- Keywords
- High Blood Pressure, Exercise, Diet, Biomarkers
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH dietBehavioural
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 plus Weight lossBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DASH diet | Experimental | Not described Receives: Behavioral: DASH diet |
| DASH diet plus Weight loss | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 4 months
Secondary outcomes (1)
Ambulatory blood pressure,vascular function,left ventricular geometry, glucose tolerance,body composition, quality of life
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startOct 2003
- Primary completionJul 2009
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- James A. Blumenthal, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571844
- Sponsor's protocol ID
- Pro00007858
- Other IDs
- 5R01HL074103, 4842
- Acronym
- ENCORE
- Status last verified
- Nov 2013
- First submitted
- 10 Dec 2007
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12875806The 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.
PubMed 9385294Blumenthal 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.
PubMed 10888969Appel 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.
PubMed 9099655Sacks 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.
PubMed 11136953Blumenthal 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.
PubMed 12090370Linden W, Chambers L. Clinical effectiveness of non-drug treatment for hypertension: a meta-analysis. Ann Behav Med. 16:35-45, 1994.
Jeffery RW. Weight management and hypertension. Ann Behav Med. 13:18-22, 1991.
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.
PubMed 10450298Svetkey 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.
PubMed 9989541Hinderliter 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.
PubMed 12076231Blumenthal 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.
PubMed 1920698Hinderliter 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.
PubMed 34107031Hinderliter 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.
PubMed 24084586Epstein 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.
PubMed 23000025
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Treatment of High Blood Pressure
- ClinicalTrials.gov ID
- NCT00571844
- Acronym / sponsor ID
- ENCORE / Pro00007858
- Conditions
- Hypertension
- Keywords
- High Blood Pressure, Exercise, Diet, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2003
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH dietParticipants 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). | Behavioural | DASH diet |
| DASH diet plus Weight lossParticipants 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. | Behavioural | DASH diet plus Weight loss |
Primary outcome
Blood pressure
Time frame: 4 months
1 secondary outcome
Ambulatory blood pressure,vascular function,left ventricular geometry, glucose tolerance,body composition, quality of life
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- Background: PubMed 12875806Svetkey 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.
- Background: PubMed 9385294The 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.
- Background: PubMed 10888969Blumenthal 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.
- Background: PubMed 9099655Appel 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.
- Background: PubMed 11136953Sacks 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.
- Background: PubMed 12090370Blumenthal 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.
- BackgroundLinden W, Chambers L. Clinical effectiveness of non-drug treatment for hypertension: a meta-analysis. Ann Behav Med. 16:35-45, 1994.
- BackgroundJeffery RW. Weight management and hypertension. Ann Behav Med. 13:18-22, 1991.
- Background: PubMed 10450298Windhauser 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.
- Background: PubMed 9989541Svetkey 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.
- Background: PubMed 12076231Hinderliter 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.
- Background: PubMed 1920698Blumenthal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A. Blumenthal, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH diet and DASH diet plus Weight loss in people with Hypertension, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571844, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.