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

NCT03924531 | Completed DMC

• 1 other identifier: 17-000411
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Health Behavior Modification Using Mindfulness

Keywords

Hypertension; Health Behavior; Mindfulness; Meditation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Blood pressure measurements

  up to 12 weeks

Study Arms (2)

Mindful Awareness Program

EXPERIMENTAL

The group that received mindfulness training.

Behavioral: Mindful Awareness Program

Health Promotion Program

ACTIVE COMPARATOR

The group that received the health information.

Behavioral: Health Promotion Program

Interventions

Mindful Awareness Program BEHAVIORAL

2-hour mindfulness training for 6 weeks.

Also known as: Mindfulness training

Mindful Awareness Program

Health Promotion Program BEHAVIORAL

Health Promotion Program

Health Promotion Program

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Hypertension; Health Behavior

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 23, 2019
• Study Start: August 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: December 22, 2025

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)