NCT03168789

Brief Summary

This study is 12 months long and consists of 5 visits at baseline, months 1, 3, 6, and 12. To determine eligibility potential subjects will have resting blood pressures (BP) measured on 2 occasions. Pre-hypertensive individuals will be invited to participate in the study. After informed consent is obtained, subjects will complete baseline visit consisting of a survey, resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Subjects will then be randomly assigned to Tension Tamer (TT) or lifestyle education program delivered via smartphone (SPCTL) groups. At the remaining 4 visits subjects will again complete a survey, resting BP, wear activity watch for 7 days ambulatory blood pressure monitor for 24-hours, collect saliva and urine samples. Throughout the 12 months TT group will meditate twice daily and SPCTL group will log physical activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

3.1 years

First QC Date

May 25, 2017

Last Update Submit

January 13, 2020

Conditions

Pre-hypertension

Keywords

Breathing Awareness Meditation,

Outcome Measures

Primary Outcomes (1)

  • Resting BP

    Resting SBP reduction target -7 mmHg.

    12 months

Secondary Outcomes (1)

  • Ambulatory SBP

    12 months

Study Arms (2)

Tension Tamer (TT)

EXPERIMENTAL

Breathing Awareness Mediation delivered by smartphone app.

Behavioral: Tension Tamer (TT)

Lifestyle education program (SPCTL)

ACTIVE COMPARATOR

Healthy lifestyle education provided by text messages and links to media. Runkeeper app to log physical activity.

Behavioral: Lifestyle education program (SPCTL)

Interventions

Tension Tamer (TT)BEHAVIORAL

Tension Tamer is an app that provides training and motivation for breathing awareness meditation (BAM). The app also tracks heart rate values during each session by placing a finger tip over the rear camera.

Tension Tamer (TT)
Lifestyle education program (SPCTL)BEHAVIORAL

SPCTL group will use Runkeeper app to log physical activity. They will also receive text messages with short healthy lifestyle tips, and links to media with pamphlets or videos with more in-depth information.

Lifestyle education program (SPCTL)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old, male or female, African American (AA) or White;
  • Stage 1 or 2 pre-hypertensive (i.e., SBP 120-139/DBP\<90) based upon 2 consecutive clinic evaluations;
  • Body Mass Index (BMI) 18.5 -45 Kg/m2;
  • legally competent;
  • able to use a smart phone.

You may not qualify if:

  • type two diabetes or chronic kidney disease (GFR\<50 mL/1.7 m2/min.);
  • cancer diagnosis or treatment in past 2 years;
  • prior cardiovascular event, congestive heart failure or angina;
  • prior or current psychiatric illness;
  • ongoing substance abuse (e.g., \>21 drinks/week);
  • pharmacologic medications which may influence blood pressure (BP);
  • planned pregnancy;
  • vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Adams ZW, Sieverdes JC, Brunner-Jackson B, Mueller M, Chandler J, Diaz V, Patel S, Sox LR, Wilder S, Treiber FA. Meditation smartphone application effects on prehypertensive adults' blood pressure: Dose-response feasibility trial. Health Psychol. 2018 Sep;37(9):850-860. doi: 10.1037/hea0000584. Epub 2018 Jul 16.

    PMID: 30010353DERIVED

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Frank A Treiber, PhD

    MUSC College of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director TACHL, College of Nursing

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 30, 2017

Study Start

October 1, 2016

Primary Completion

November 22, 2019

Study Completion

November 22, 2019

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)