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Engaging Native Hawaiian/Pacific Islanders and Activating Communities to Take Steps (ENACTS)

Engaging Native Hawaiian/Pacific Islanders and Activating Communities to Take Steps (ENACTS)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03484364
Acronym
ENACTS
Enrollment
182
Registered
2018-03-30
Start date
2018-06-15
Completion date
2025-01-24
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief 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 mean change in other adult family members who are not directly engaged in the intervention. 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.

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.

Interventions

BEHAVIORALENACTS

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.

Sponsors

Washington State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Systolic Blood Pressure6 monthsAutomatic blood pressure

Secondary

MeasureTime frameDescription
Food Purchasing6 monthsGrocery receipts
Medication Adherence6 monthsHill Bone High Blood Pressure Compliance Scale
Eating Behaviors6 months24 hour dietary recall
Tobacco Use6 monthsNational Health Interview Survey
Daily Energy Expenditure6 monthsInternational Physical Activity Questionnaire (IPAQ)
Social Support6 monthsFamily care climate questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026