deltatrials
Terminated PHASE2 INTERVENTIONAL 2-arm NCT00583310

Telephone-Based Lifestyle Intervention to Reduce Blood Pressure in Prehypertensive Patients

Sponsor: American Heart Association

Updated 7 times since 2017 Last updated: Nov 18, 2013 Started: Jan 31, 2007 Primary completion: Feb 28, 2010 Completion: Jul 31, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

PI left institution

Listed as NCT00583310, this PHASE2 trial focuses on High Blood Pressure and remains terminated or withdrawn. Sponsored by American Heart Association, it has been updated 7 times since 2007, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Individuals with prehypertension are at increased cardiovascular risk compared with normotension, as well as increased risk of progression to sustained hypertension. The recommended treatment for prehypertension is lifestyle modification, including weight loss, adoption of the Dietary Approaches to Stop Hypertension (DASH) diet, reduction of dietary sodium, physical activity, and moderation of alcohol intake. The proposed pilot study will test the effect of a 4 session telephone-based lifestyle intervention on blood pressure change in 125 prehypertensive participants. The intervention includes education and behavioral counseling strategies that have been shown to be effective in promoting behavior change and reducing blood pressure among hypertensives. Following baseline assessment, participants will be randomized to the intervention or usual care, and will complete follow-up assessments at 6 weeks and 3 months post-randomization. The primary aim of the study is to examine the effect of the intervention on blood pressure at 3 months. Secondary aims include examining intervention effects on lifestyle behavior changes at 6 weeks and 3 months. This study will provide pilot and feasibility data for a future application to study effects of the intervention on risk factor modification, blood pressure reduction, and cardiovascular morbidity and mortality. If successful, this brief, cost-effective intervention could easily...

Individuals with prehypertension are at increased cardiovascular risk compared with normotension, as well as increased risk of progression to sustained hypertension. The recommended treatment for prehypertension is lifestyle modification, including weight loss, adoption of the Dietary Approaches to Stop Hypertension (DASH) diet, reduction of dietary sodium, physical activity, and moderation of alcohol intake. The proposed pilot study will test the effect of a 4 session telephone-based lifestyle intervention on blood pressure change in 125 prehypertensive participants. The intervention includes education and behavioral counseling strategies that have been shown to be effective in promoting behavior change and reducing blood pressure among hypertensives.

Following baseline assessment, participants will be randomized to the intervention or usual care, and will complete follow-up assessments at 6 weeks and 3 months post-randomization. The primary aim of the study is to examine the effect of the intervention on blood pressure at 3 months. Secondary aims include examining intervention effects on lifestyle behavior changes at 6 weeks and 3 months. This study will provide pilot and feasibility data for a future application to study effects of the intervention on risk factor modification, blood pressure reduction, and cardiovascular morbidity and mortality. If successful, this brief, cost-effective intervention could easily be incorporated into routine care, and could have a significant impact on the management of prehypertension.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Jun 2019 · 12 months · monthly snapshotTerminated~Jun 2019 – ~Jan 2021 · 19 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated~Jan 2026 – present · 3 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE2

  2. Sep 2024 — Present [monthly]

    Terminated PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  5. Jun 2019 — Jan 2021 [monthly]

    Terminated PHASE2

Show 2 earlier versions
  1. Jun 2018 — Jun 2019 [monthly]

    Terminated PHASE2

  2. Jan 2017 — Jun 2018 [monthly]

    Terminated PHASE2

    First recorded

Jan 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • American Heart Association
  • NYU Langone Health
  • UNITE HERE Health Center
Data source: NYU Langone Health

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations