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

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ENACTS
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • National Recruitment via Facebook and InternetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Waitlist Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Systolic Blood Pressure
Automatic blood pressure

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2018
Last Updated
August 10, 2023
Sponsor
Washington State University
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1. Study Identification

Unique Protocol Identification Number
NCT03484364
Brief Title
Engaging Native Hawaiian/Pacific Islanders and Activating Communities to Take Steps (ENACTS)
Acronym
ENACTS
Official Title
Engaging Native Hawaiian/Pacific Islanders and Activating Communities to Take Steps (ENACTS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
March 28, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Our Specific Aims are: At the individual level, to compare within-person change in BP and secondary outcomes between the intervention and control groups. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The ENACTS intervention is four peer-facilitated educational classes delivered over 8 weeks focused on hypertension self-management.
Arm Title
Waitlist Group
Arm Type
No Intervention
Arm Description
Usual care and $50 in groceries every other week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
ENACTS
Other Intervention Name(s)
Healthy Hearts Among Pacific Islanders (HHAPI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
Automatic blood pressure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Eating Behaviors
Description
24 hour dietary recall
Time Frame
6 months
Title
Food Purchasing
Description
Grocery receipts
Time Frame
6 months
Title
Medication Adherence
Description
Hill Bone High Blood Pressure Compliance Scale
Time Frame
6 months
Title
Social Support
Description
Family care climate questionnaire
Time Frame
6 months
Title
Tobacco Use
Description
National Health Interview Survey
Time Frame
6 months
Title
Daily Energy Expenditure
Description
International Physical Activity Questionnaire (IPAQ)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise A Dillard
Phone
2067088633
Email
denise.dillard@wsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Odile Madesclaire
Phone
2067088617
Email
odile.madesclaire@wsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
denise dillard
Organizational Affiliation
Washington State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Recruitment via Facebook and Internet
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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