Tension Tamer Randomized Control Trial
Completed · Not applicable
Conditions studied: Pre-hypertension
In brief
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.
Key facts
- Study ID
- NCT03168789
- Run by
- Medical University of South Carolina
- People needed
- 80
- Starts
- 2016-10-01
- Expected to finish
- 2019-11-22
- Last updated by the study team
- 2020-01-14
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18-90 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…
- failure to meet any inclusion criteria;
- 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.
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.