Health Behavior Modification Using MindfulnessNCT03924531
Promoting Adherence to Anti-Hypertensive Medications and Lifestyle Guidelines Through Mindfulness Practice
A study testing Mindful Awareness Program and Health Promotion Program in people with Health Behavior Modification Using Mindfulness, run by University of California, Los Angeles at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior Modification Using Mindfulness
- What is being tested?
- Mindful Awareness Program and Health Promotion Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Being tested
- Mindful Awareness Program, Health Promotion Program
- Keywords
- Hypertension, Health Behavior, Mindfulness, Meditation
- Medical subject headings
- Hypertension, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Awareness ProgramBehavioural
Also called Mindfulness training
2-hour mindfulness training for 6 weeks.
Health Promotion ProgramBehavioural
Health Promotion Program
| Study group | Role | What they receive |
|---|---|---|
| Mindful Awareness Program | Experimental | The group that received mindfulness training. Receives: Behavioral: Mindful Awareness Program |
| Health Promotion Program | Active comparator | The group that received the health information. Receives: Behavioral: Health Promotion Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 12 weeks
Secondary outcomes (1)
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.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Aug 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Behavior Modification Using MindfulnessStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924531
- Sponsor's protocol ID
- 17-000411
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2019
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adherence to Anti-Hypertensive Medications and Lifestyle Guidelines Through Mindfulness Practice
- ClinicalTrials.gov ID
- NCT03924531
- Acronym / sponsor ID
- 17-000411
- Keywords
- Hypertension, Health Behavior, Mindfulness, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Awareness Program | Experimental | Behavioral: Mindful Awareness ProgramThe group that received mindfulness training. |
| Health Promotion Program | Active comparator | Behavioral: Health Promotion ProgramThe group that received the health information. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Awareness ProgramAlso: Mindfulness training2-hour mindfulness training for 6 weeks. | Behavioural | Mindful Awareness Program |
| Health Promotion ProgramHealth Promotion Program | Behavioural | Health Promotion Program |
Primary outcome
Diet
Time frame: up to 12 weeks
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.
Exercise
Time frame: up to 12 weeks
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.
Blood pressure medication adherence
Time frame: up to 12 weeks
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.
1 secondary outcome
Blood pressure measurements
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Awareness Program and Health Promotion Program in people with Health Behavior Modification Using Mindfulness, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet (time frame: up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.