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

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: ENACTS

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 Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denise A Dillard; Phone Number: 2067088633; Email: denise.dillard@wsu.edu
• Study Contact Backup: Name: Odile Madesclaire; Phone Number: 2067088617; Email: odile.madesclaire@wsu.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Recruiting
      • National Recruitment via Facebook and Internet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The ENACTS intervention is four peer-facilitated educational classes delivered over 8 weeks focused on hypertension self-management.	Behavioral: ENACTS; 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)
No Intervention: Waitlist Group; Usual care and $50 in groceries every other week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	Automatic blood pressure	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Behaviors	24 hour dietary recall	6 months
Food Purchasing	Grocery receipts	6 months
Medication Adherence	Hill Bone High Blood Pressure Compliance Scale	6 months
Social Support	Family care climate questionnaire	6 months
Tobacco Use	National Health Interview Survey	6 months
Daily Energy Expenditure	International Physical Activity Questionnaire (IPAQ)	6 months

Collaborators and Investigators

• Sponsor: Washington State University
• Investigators: Principal Investigator: denise dillard, Washington State University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Estimated): March 28, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: U54MD011240 127687; U54MD011240 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No