Clinical trial NCT03924531: Promoting Adherence to Anti-Hypertensive Medications and Lifestyle Guidelines Through Mindfulness Practice
Official title: Promoting Adherence to Anti-Hypertensive Medications and Lifestyle Guidelines Through Mindfulness Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior Modification Using Mindfulness
Keywords: Hypertension
Health Behavior
Mindfulness
Meditation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Adherence is a major problem for the approximately one-third of Americans over the age of 20 who suffer from Hypertension (HTN). Hypertension can be controlled through medication adherence and lifestyle modifications (diet and exercise). However, nearly 50% of those with HTN report poor adherence to their antihypertensive medications, lifestyle changes, or both as primary reasons for failing to control their blood pressure. Currently, behavioral interventions are limited to providing education or reminding individuals to take better care of themselves by starting and adhering to proper diet and exercise program. Given the lack of adherence reported, education and reminders alone may not be sufficient to promote health behavior change. Interventions that appeal to individual's internal drive may be more effective, given that behavior adoption and maintenance are usually associated with intrinsic motivation and volition. Mindfulness practice is an intervention that shows promise in changing lifestyle behaviors. The purpose of this study is to investigate the use of UCLA's Mindful Awareness Program (UCLAMAP) on promoting self-management behaviors, specifically adherence to medication, diet, and exercise for those individuals with HTN. We will randomize 52 individuals with HTN who have difficulty with adherence to antihypertensive medications and lifestyle changes to the intervention group or the attention-control group. The intervention includes six sessions of the mindfulness training through UCLA's Mindful Awareness Research Center (MARC).


Eligibility criteria: Inclusion Criteria:

* over 21 years of age
* able to understand and speak English
* self-report of having difficulty with a healthy diet and engaging in regular physical activity.

Exclusion Criteria:

* On chemotherapy for cancer treatment
* Current substance abuse disorder (i.e., drugs, alcohol).
* Current diagnoses of Post-traumatic stress disorders, severe anxiety, or severe depression.
* On hemodialysis.
* Pregnant. (Pregnant women may develop Preeclampsia, which is a pregnancy complication characterized by high blood pressure)

Primary outcomes:
measure: Diet
timeFrame: up to 12 weeks
measure: Exercise
timeFrame: up to 12 weeks
measure: Blood pressure medication adherence
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Blood pressure measurements
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
References: