NCT03484364

Brief Summary

Our Specific Aims are:

  1. 1.At the individual level, to compare within-person change in BP and secondary outcomes between the intervention and control groups.
  2. 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 mean change in other adult family members who are not directly engaged in the intervention.
  3. 3.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2025

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

6.6 years

First QC Date

March 15, 2018

Last Update Submit

October 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure

    Automatic blood pressure

    6 months

Secondary Outcomes (6)

  • Eating Behaviors

    6 months

  • Food Purchasing

    6 months

  • Medication Adherence

    6 months

  • Social Support

    6 months

  • Tobacco Use

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

The ENACTS intervention is four peer-facilitated educational classes delivered over 8 weeks focused on hypertension self-management.

Behavioral: ENACTS

Waitlist Group

NO INTERVENTION

Usual care and $50 in groceries every other week for 8 weeks.

Interventions

ENACTSBEHAVIORAL

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.

Also known as: Healthy Hearts Among Pacific Islanders (HHAPI)
Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • current email address
  • \*Ability to understand written and spoken English; and
  • \*Ability and willingness to follow all study protocols.

You may not qualify if:

  • Pregnant or planning on becoming pregnant throughout the course of the study;
  • Currently undergoing dialysis or treatment for a terminal illness;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Recruitment via Facebook and Internet

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • denise dillard

    Washington State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 30, 2018

Study Start

June 15, 2018

Primary Completion

January 24, 2025

Study Completion

January 24, 2025

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations