PREMIER: Lifestyle Interventions for Blood Pressure Control (PREMIER)

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Accession Number
HLB00540609a

Study Type
Clinical Trial

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

Study Period
1998-2004

NHLBI Division
DCVS

Dataset(s) Last Updated
January 3, 2018

Clinical Trial URLs
https://clinicaltrials.gov/show/NCT00000616

Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pubmed/12709466

Consent

Commercial Use Data Restrictions No

Data Restrictions Based On Area Of Research No

Commercial Use Specimen Restrictions No

Non-Genetic Use Specimen Restrictions Based On Area Of Use Yes

Genetic Use Of Specimens Allowed? Yes

Genetic Use Area Of Research Restrictions Yes

Specific Consent Restrictions
Restrictions are related to genetic/non-genetic biospecimen use by research topic.

Objectives

To determine the effect on blood pressure (BP) of 2 multicomponent, behavioral interventions.

Background

Weight loss, sodium reduction, increased physical activity, and limited alcohol intake are established recommendations that reduce BP. The Dietary Approaches to Stop Hypertension (DASH) diet also lowers BP. To date, no trial has evaluated the effects of simultaneously implementing these lifestyle recommendations.

Subjects

Randomized trial with enrollment at 4 clinical centers (January 2000-June 2001) among 810 adults (mean [SD] age, 50 [8.9] years; 62% women; 34% African American) with above-optimal BP, including stage 1 hypertension (120-159 mm Hg systolic and 80-95 mm Hg diastolic), and who were not taking antihypertensive medications.

Design

Randomized controlled clinical trial that tested two behavioral interventions compared with an advice-only group over a period of 18 months. The two interventions promoted established recommendations that reduce BP. One intervention in addition promoted the DASH diet, which is rich in fruits, vegetables, and low-fat dairy products, and low in saturated fat, total fat, and cholesterol.

Conclusions

Individuals with above-optimal BP, including stage 1 hypertension, can make and largely sustain multiple lifestyle changes. These lifestyle changes lower BP, improve BP control, and may reduce cardiovascular disease risk. (JAMA 2003;289:2083-2093; Ann Intern Med 2006;144:485-495).

Additional Details

Subjects:

Premier A: 273

Premier B: 268

Premier C: 269

Age:

 

PREMIER A

PREMIER B

PREMIER C

All

N

%

N

%

N

%

N

%

=< 30

2

0.73

6

2.24

3

1.12

11

1.36

31-35

12

4.40

8

2.99

11

4.09

31

3.83

36-40

22

8.06

21

7.84

26

9.67

69

8.52

41-45

53

19.41

37

13.81

44

16.36

134

16.54

46-50

74

27.11

69

25.75

49

18.22

192

23.70

51-55

50

18.32

57

21.27

63

23.42

170

20.99

56-60

25

9.16

40

14.93

41

15.24

106

13.09

61-65

19

6.96

20

7.46

20

7.43

59

7.28

66-70

12

4.40

7

2.61

5

1.86

24

2.96

>= 71

4

1.47

3

1.12

7

2.60

14

1.73
 
Sex:
 

 

PREMIER A

PREMIER B

PREMIER C

All

N

%

N

%

N

%

N

%

Male

101

37.00

94

35.07

115

42.75

310

38.27

Female

172

63.00

174

64.93

154

57.25

500

61.73
 
Race:

 

PREMIER A

PREMIER B

PREMIER C

All

N

%

N

%

N

%

N

%

non-Black

173

63.37

168

62.69

190

70.63

531

65.56

Black

100

36.63

100

37.31

79

29.37

279

34.44
 

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process

Visits (Vials):

03/04/2019

  Serum Plasma Buffy Coat Urine Total
Baseline 4,497 2,553 791 6,630 14,471
6 Month 4,282 2,423 0 5,954 12,659
18 Month 4,176 2,779 0 7,037 13,992
Unknown 3 0 0 0 3

 
Visits (Subjects):

03/04/2019

  Serum
Total number of subjects Average volume (ml) per subject
Baseline 806 4.58
6 Month 741 4.56
18 Month 751 4.24
Unknown 3 1.18
 
  Plasma
Total number of subjects Average volume (ml) per subject
Baseline 804 2.84
6 Month 741 2.92
18 Month 750 2.90
 
  Urine
Total number of subjects Average volume (ml) per subject
Baseline 802 15.14
6 Month 640 14.85
18 Month 688 18.98
 
  Buffy Coat
Total number of subjects Average vials per subject
Baseline 791 1.00

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Resources Available

Specimens and Study Datasets

Study Catalog

Study Publications (9)

Materials Available

Study Documents

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