HypertensionENACTSNCT03484364
Engaging Native Hawaiian/Pacific Islanders and Activating Communities to Take Steps (ENACTS)
A study testing ENACTS in people with Hypertension, run by Washington State University at 1 site in United States.
Trial summary
Our Specific Aims are: 1. At the individual level, to compare within-person change in BP and secondary outcomes between the intervention and control groups. 2. At the family level, to evaluate ENACTS' effects on BP and secondary outcomes as within-person change in family members who provide primary support, and as… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- ENACTS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 24 Jan 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported physician diagnosis of hypertension and/or type 2 diabetes confirmed by a prescription for an anti-hypertensive medication and/or type 2 diabetes medication;
- Self-reported NHPI race;
- *Age 18 years and older at enrollment;
- Measured systolic BP ≥ 140 mmHg on enrollment; measured baseline fasting glucose >125
- reliable internet access
- computer or Smartphone
Show all 9Show fewer
- current email address
- *Ability to understand written and spoken English; and
- *Ability and willingness to follow all study protocols.
Who cannot join
- Pregnant or planning on becoming pregnant throughout the course of the study;
- Currently undergoing dialysis or treatment for a terminal illness;
Trial locations and contacts
1 site in 1 country.
United States1 site
National Recruitment via Facebook and Internet
Seattle, Washington, 98101
About this study
Our Specific Aims are:
- At the individual level, to compare within-person change in BP and secondary outcomes between the intervention and control groups.
- At the family level, to evaluate ENACTS' effects on BP and secondary outcomes as within-person change in family members who provide primary support, and as mean change in other adult family members who are not directly engaged in the intervention.
- At the policy level, to evaluate the intervention's ability to influence grocery store policy on clearly identifying foods that are low in sodium or high in potassium, some of which might not be easily identified with existing labels (e.g., fresh produce). ENACTS combines empirically supported elements of existing programs, thus increasing its probability of success. It aligns with the American Heart Association's call for multilevel prevention.
Read the detailed description
This study adapts an existing educational intervention to address self-management of hypertension in NHPIs. The multilevel 6-month intervention - "Engaging NHPIs and Activating Communities to Take Steps" (ENACTS) - will use peer-facilitated, self-care BP education delivered weekly for 8 weeks emphasizing healthy diet, traditional NHPI foods, adherence to medication, and encouragement to increase physical activity and stop smoking; with text messaging to boost adherence. ENACTS will be implemented as a randomized controlled trial at 3 community sites serving NHPIs in the Puget Sound area of Washington. 270 NHPI adults (90 per site) with a self-reported physician diagnosis of hypertension and elevated BP measured at enrollment will be randomized to either ENACTS or usual care.
The primary outcome is change in systolic BP. Secondary outcomes are food purchasing behaviors (online ordering, grocery receipts); medication adherence; social support; smoking cessation; and GIS data on daily energy expenditure. The study will use a Geographic Information Systems (GIS) mobile phone app to track participants. Outcomes will be measured at baseline, weekly, at 8 weeks, and at 6 months. The study will also examine change in household food purchasing patterns, enhanced family support for BP control, and BP improvement among family members. A subset of intervention participants and family members will be invited to participate in a program that uses personal photographs for narrative art projects to promote labeling of healthy foods by local retail outlets.
- Conditions
- Hypertension
- Being tested
- ENACTS
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENACTSBehavioural
Also called Healthy Hearts Among Pacific Islanders (HHAPI)
Peer-facilitated, self-care BP education delivered every other week for 8 weeks emphasizing healthy diet, traditional NHPI foods, adherence to medication, and encouragement to increase physical activity and stop smoking, with text messaging to boost adherence. $50 of groceries every other week (4 times) over 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The ENACTS intervention is four peer-facilitated educational classes delivered over 8 weeks focused on hypertension self-management. Receives: Behavioral: ENACTS |
| Waitlist Group | No intervention | Usual care and $50 in groceries every other week for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Automatic blood pressure
Measured: 6 months
Secondary outcomes (6)
Eating Behaviors
24 hour dietary recall
Measured: 6 months
Food Purchasing
Grocery receipts
Measured: 6 months
Medication Adherence
Hill Bone High Blood Pressure Compliance Scale
Measured: 6 months
Social Support
Family care climate questionnaire
Measured: 6 months
Tobacco Use
National Health Interview Survey
Measured: 6 months
Daily Energy Expenditure
International Physical Activity Questionnaire (IPAQ)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start15 Jun 2018
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Dillard, Washington State University
- Investigators
- denise dillard, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484364
- Sponsor's protocol ID
- U54MD011240 127687
- Other IDs
- U54MD011240
- Acronym
- ENACTS
- Status last verified
- Oct 2025
- First submitted
- 15 Mar 2018
- Last updated
- 20 Oct 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 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Native Hawaiian/Pacific Islanders and Activating Communities to Take Steps (ENACTS)
- ClinicalTrials.gov ID
- NCT03484364
- Acronym / sponsor ID
- ENACTS / U54MD011240 127687
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 30 Mar 2018 (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.
Our Specific Aims are:
- At the individual level, to compare within-person change in BP and secondary outcomes between the intervention and control groups.
- At the family level, to evaluate ENACTS' effects on BP and secondary outcomes as within-person change in family members who provide primary support, and as mean change in other adult family members who are not directly engaged in the intervention.
- At the policy level, to evaluate the intervention's ability to influence grocery store policy on clearly identifying foods that are low in sodium or high in potassium, some of which might not be easily identified with existing labels (e.g., fresh produce). ENACTS combines empirically supported elements of existing programs, thus increasing its probability of success. It aligns with the American Heart Association's call for multilevel prevention.
Detailed description
This study adapts an existing educational intervention to address self-management of hypertension in NHPIs. The multilevel 6-month intervention - "Engaging NHPIs and Activating Communities to Take Steps" (ENACTS) - will use peer-facilitated, self-care BP education delivered weekly for 8 weeks emphasizing healthy diet, traditional NHPI foods, adherence to medication, and encouragement to increase physical activity and stop smoking; with text messaging to boost adherence. ENACTS will be implemented as a randomized controlled trial at 3 community sites serving NHPIs in the Puget Sound area of Washington. 270 NHPI adults (90 per site) with a self-reported physician diagnosis of hypertension and elevated BP measured at enrollment will be randomized to either ENACTS or usual care.
The primary outcome is change in systolic BP. Secondary outcomes are food purchasing behaviors (online ordering, grocery receipts); medication adherence; social support; smoking cessation; and GIS data on daily energy expenditure. The study will use a Geographic Information Systems (GIS) mobile phone app to track participants. Outcomes will be measured at baseline, weekly, at 8 weeks, and at 6 months. The study will also examine change in household food purchasing patterns, enhanced family support for BP control, and BP improvement among family members. A subset of intervention participants and family members will be invited to participate in a program that uses personal photographs for narrative art projects to promote labeling of healthy foods by local retail outlets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: ENACTSThe ENACTS intervention is four peer-facilitated educational classes delivered over 8 weeks focused on hypertension self-management. |
| Waitlist Group | No intervention | –Usual care and $50 in groceries every other week for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Self-reported physician diagnosis of hypertension and/or type 2 diabetes confirmed by a prescription for an anti-hypertensive medication and/or type 2 diabetes medication;
- Self-reported NHPI race;
- *Age 18 years and older at enrollment;
- Measured systolic BP ≥ 140 mmHg on enrollment; measured baseline fasting glucose >125
- reliable internet access
Key exclusion criteria (2 listed)
- Pregnant or planning on becoming pregnant throughout the course of the study;
- Currently undergoing dialysis or treatment for a terminal illness;
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 |
|---|---|---|
| ENACTSAlso: Healthy Hearts Among Pacific Islanders (HHAPI)Peer-facilitated, self-care BP education delivered every other week for 8 weeks emphasizing healthy diet, traditional NHPI foods, adherence to medication, and encouragement to increase physical activity and stop smoking, with text messaging to boost adherence. $50 of groceries every other week (4 times) over 8 weeks. | Behavioural | Intervention Group |
Primary outcome
Systolic Blood Pressure
Time frame: 6 months
Automatic blood pressure
6 secondary outcomes
Eating Behaviors
Time frame: 6 months
Food Purchasing
Time frame: 6 months
Medication Adherence
Time frame: 6 months
Social Support
Time frame: 6 months
Tobacco Use
Time frame: 6 months
Daily Energy Expenditure
Time frame: 6 months
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 20 Oct 2025.
- Individual participant dataSharing planned: No
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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.
denise dillard principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENACTS in people with Hypertension, run by Washington State University 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 9 inclusion and 2 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 20 Oct 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?
Systolic Blood Pressure (time frame: 6 months). 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 20 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.