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OpenTrials
Completed

NCT Number: NCT03484364

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Recruitment via Facebook and Internet

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

ENACTS

Behavioral

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.

Other names: Healthy Hearts Among Pacific Islanders (HHAPI)

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: 6 months

    Automatic blood pressure

Secondary outcomes

  1. Eating Behaviors

    Time frame: 6 months

    24 hour dietary recall

  2. Food Purchasing

    Time frame: 6 months

    Grocery receipts

  3. Medication Adherence

    Time frame: 6 months

    Hill Bone High Blood Pressure Compliance Scale

  4. Social Support

    Time frame: 6 months

    Family care climate questionnaire

  5. Tobacco Use

    Time frame: 6 months

    National Health Interview Survey

  6. Daily Energy Expenditure

    Time frame: 6 months

    International Physical Activity Questionnaire (IPAQ)

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Registry information

Acronym: ENACTS

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2018
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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