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Home > Studies > PREMIER > Catalog

PREMIER: Lifestyle Interventions for Blood Pressure Control (PREMIER) - Catalog

Basic Study Information

Name

PREMIER: Lifestyle Interventions for Blood Pressure Control (PREMIER)

Accession Number

HLB00540609a

Acronym

PREMIER

Related studies

BSI Study IDs

PRE

Is public use dataset

False

Keywords

Has Study Datasets

True

Has Specimens

True

Specimen ID Type

Coded

Study Website

The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

False

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

Clinical Trial

Collection Type

Open BioLINCC Study

Cohort type

Adult

Interventions

Behavioral: diet, sodium-restrictedBehavioral: diet, fat-restrictedBehavioral: exerciseBehavioral: diet, reducingBehavioral: alcohol drinking

Study Open Date (Data)

2009-10-01

Study Open Date (Specimens)

2010-10-29

Date materials available

2009-05-20

Last updated

2006-05-08

Study period

1998-2004

Study Contacts
NHLBI Division

DCVS

Classification

Heart

HIV study classification

non-HIV

COVID study classification

non-COVID

Pre-Website # of Specimens Shipped

2211

# of Returned Specimens

0

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

Study 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.

Additional Study Information

Conditions

Heart Diseases
Hypertension

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).

Disease classification

Publications

Mat types

Buffy Coat
Plasma
Serum
Urine

Study Population

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • Subjects

    Premier A: 273

    Premier B: 268

    Premier C: 269


    Last Modified: Aug. 25, 2015, 3:02 p.m.
  • 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

     

    Last Modified: Aug. 25, 2015, 3:02 p.m.
  • 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

     

    Last Modified: Aug. 25, 2015, 3:02 p.m.
  • 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

     

    Last Modified: Aug. 25, 2015, 3:02 p.m.

Available Biospecimens

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

  • Material Types

    Last Modified: Nov. 30, 2015, 2:08 p.m.
  • General Freeze/Thaw Status
  • 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

     

    Last Modified: March 25, 2021, 3:30 p.m.
  • 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

    Last Modified: March 4, 2019, 4:20 p.m.
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