Promoting Adherence to Anti-Hypertensive Medications and Lifestyle Guidelines Through Mindfulness Practice

Promoting Adherence to Anti-Hypertensive Medications and Lifestyle Guidelines Through Mindfulness Practice

Sponsors

Lead sponsor: University of California, Los Angeles

Source University of California, Los Angeles
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).

Overall Status Completed
Start Date August 1, 2017
Completion Date March 31, 2019
Primary Completion Date March 31, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Diet up to 12 weeks
Exercise up to 12 weeks
Blood pressure medication adherence up to 12 weeks
Secondary Outcome
Measure Time Frame
Blood pressure measurements up to 12 weeks
Enrollment 36
Condition
Intervention

Intervention type: Behavioral

Intervention name: Mindful Awareness Program

Description: 2-hour mindfulness training for 6 weeks.

Arm group label: Mindful Awareness Program

Other name: Mindfulness training

Intervention type: Behavioral

Intervention name: Health Promotion Program

Description: Health Promotion Program

Arm group label: Health Promotion Program

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)

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Location
facility UCLA
Location Countries

United States

Verification Date

April 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of California, Los Angeles

Investigator full name: Eunjoo An

Investigator title: PhD student

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Mindful Awareness Program

Arm group type: Experimental

Description: The group that received mindfulness training.

Arm group label: Health Promotion Program

Arm group type: Active Comparator

Description: The group that received the health information.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov