Tension Tamer Randomized Control Trial

Pre-hypertension Clinical Trial

Official title:

Smartphone Delivered Meditation for BP Control Among Prehypertensives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03168789
• Other study ID #: Pro00020894
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: November 22, 2019

Study information

• Verified date: January 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

80 stage 1 or 2 pre-hypertensive adults, will be randomly assigned to 2x daily TT at scheduled decreasing doses or enhanced standard of care lifestyle education program delivered via smartphone (SPCTL) for 12 months. Subjects will participate in 5 study visits at baseline/enrollment, 1, 3, 6 , and 12 months

TT subjects will be given the TT app. The app provides instructions on breathing awareness meditation (BAM): focusing upon the moment by sustaining one's attention upon diaphragm movements and related sensations while breathing in a slow, deep, relaxed manner. One learns to passively observe thoughts, images and extraneous sounds without making judgments about them. BAM doesn't involve analysis of historical or recent stressful experiences, but instead centers upon learning to stay in the present moment while meditating. The app will also collect heart rate (HR) values during each session using the phone's camera. The duration of the TT sessions will begin at 15 min., decrease to 10 min., and finally decrease to 5 min. Adherence will be monitored by the receipt of date-stamped heart rate values collected during each meditation session.

SPCTL subjects will be provided Runkeeper app and taught how to record physical activity they perform. Recommended dosage of using SPCTL media and/or app will be that of the TT group. Adherence to SPCTL will be assessed using server file analyses of modules used and activity recorded in Runkeeper.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. 18-90 years old, male or female, African American (AA) or White;

2. Stage 1 or 2 pre-hypertensive (i.e., SBP 120-139/DBP<90) based upon 2 consecutive clinic evaluations;

3. Body Mass Index (BMI) 18.5 -45 Kg/m2;

4. legally competent;

5. able to use a smart phone.

Exclusion Criteria:

1. failure to meet any inclusion criteria;

2. type two diabetes or chronic kidney disease (GFR<50 mL/1.7 m2/min.);

3. cancer diagnosis or treatment in past 2 years;

4. prior cardiovascular event, congestive heart failure or angina;

5. prior or current psychiatric illness;

6. ongoing substance abuse (e.g., >21 drinks/week);

7. pharmacologic medications which may influence blood pressure (BP);

8. planned pregnancy;

9. vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.

Related Conditions & MeSH terms

• Pre-hypertension
• Prehypertension

Intervention

Behavioral:
• Tension Tamer (TT)
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.
• Lifestyle education program (SPCTL)
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting BP	Resting SBP reduction target -7 mmHg.	12 months
Secondary	Ambulatory SBP	24-hr SBP reduction target -4 mmHg.	12 months