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

Hypertension Clinical Trial

— ENACTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03484364
• Other study ID #: U54MD011240 127687
• Secondary ID: U54MD011240
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2023
• Source: Washington State University
• Contact: Denise A Dillard
• Phone: 2067088633
• Email: denise.dillard[@]wsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: March 31, 2025
• Est. primary completion date: March 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	National Recruitment via Facebook and Internet	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	Automatic blood pressure	6 months
Secondary	Eating Behaviors	24 hour dietary recall	6 months
Secondary	Food Purchasing	Grocery receipts	6 months
Secondary	Medication Adherence	Hill Bone High Blood Pressure Compliance Scale	6 months
Secondary	Social Support	Family care climate questionnaire	6 months
Secondary	Tobacco Use	National Health Interview Survey	6 months
Secondary	Daily Energy Expenditure	International Physical Activity Questionnaire (IPAQ)	6 months