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

  • 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
  • Ingestion Status
    Released
  • 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
    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
    12709466
  • 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.

  • 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.

  • Participants

    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
  • Network

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: Feb. 7, 2024, 1:43 p.m.
  • Age

     

    Premier A

    Premier B

    Premier C

    Total Subjects

    =< 30

    2

    6

    3

    11

    31-35

    12

    8

    11

    31

    36-40

    22

    21

    26

    69

    41-45

    53

    37

    44

    134

    46-50

    74

    69

    49

    192

    51-55

    50

    57

    63

    170

    56-60

    25

    40

    41

    106

    61-65

    19

    20

    20

    59

    66-70

    12

    7

    5

    24

    >= 71

    4

    3

    7

    14


    Last Modified: Feb. 7, 2024, 1:46 p.m.
  • Sex

     

    Premier A

    Premier B

    Premier C

    Total Subjects

    Male

    101

    94

    115

    310

    Female

    172

    174

    154

    500


    Last Modified: Feb. 7, 2024, 1:46 p.m.
  • Race

     

    Premier A

    Premier B

    Premier C

    Total Subjects

    non-Black

    173

    168

    190

    531

    Black

    100

    100

    79

    279


    Last Modified: Feb. 7, 2024, 1:46 p.m.

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 3.0 of the BioLINCC Handbook describes the components of the review process.

  • Material Types

    Serum, Plasma, Buffy Coat, Urine


    Last Modified: Feb. 7, 2024, 1:43 p.m.
  • General Freeze/Thaw Status

    As of 02/07/2024, about 2/3 of serum specimens , 1/2 of plasma specimens, and 3/4 of urine specimens have undergone at least 1 freeze-thaw cycle. Buffy coat specimens are unthawed.


    Last Modified: Feb. 7, 2024, 1:43 p.m.
  • Visits (Vials)

    02/07/2024

     

    Serum

    Plasma

    Buffy Coat

    Urine

    Total Vials

    Baseline

    3,845

    2,553

    791

    6,630

    13,819

    6 Month

    3,581

    2,423

    .

    5,954

    11,958

    18 Month

    4,175

    2,779

    .

    7,037

    13,991

    Unknown

    3

    .

    .

    .

    3


     


    Last Modified: Feb. 7, 2024, 1:48 p.m.
  • Visits (Subjects)

    02/07/2024

     

    Serum

    Total number of subjects

    Average volume (mL) per subject

    Baseline

    806

    4.39

    6 Month

    741

    4.37

    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

     

     

    Buffy Coat

    Total number of subjects

    Average volume (mL) per subject

    Baseline

    791

    1.01

     

     

    Urine

    Total number of subjects

    Average volume (mL) per subject

    Baseline

    802

    15.12

    6 Month

    640

    14.85

    18 Month

    688

    18.98


    Last Modified: Feb. 7, 2024, 1:48 p.m.