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

Health Behavior Modification Using Mindfulness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924531
• Other study ID #: 17-000411
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Health Behavior Modification Using Mindfulness

Intervention

Behavioral:
• Mindful Awareness Program
2-hour mindfulness training for 6 weeks.
• Health Promotion Program
Health Promotion Program

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet	21 item questionnaire called Rapid Eating and Activity Assessment for Patients (REAP). Various questions related to food choices. The answer choices were rarely, sometimes, and often for each food questions.	up to 12 weeks
Primary	Exercise	The instrument used was called the Brief Physical Assessment. The is a 6 item weekly questionnaire that asked the minutes the participants performed a particular exercise behavior.	up to 12 weeks
Primary	Blood pressure medication adherence	The instrument used was called the Brief Medication Questionnaire (BMQ).The tool includes a 5-item Regimen Screen that asks patients how they took each medication in the past week, a 2-item Belief Screen that asks about drug effects and bothersome features, and a 2-item Recall Screen about potential difficulties remembering. We collected the number of missed medication days.	up to 12 weeks
Secondary	Blood pressure measurements	The participants were provided with blood pressure monitors to take home and log their blood pressure measurements daily. Blood pressure measurements were collected weekly. Systolic and diastolic blood pressure measurements will be accessed.	up to 12 weeks