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

  • STATUS
    Recruiting
  • End date
    Jun 28, 2023
  • participants needed
    270
  • sponsor
    Washington State University
Updated on 4 March 2022
hypertension
potassium
hypertensive medication
Accepts healthy volunteers

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.

Details
Condition Hypertension
Treatment ENACTS
Clinical Study IdentifierNCT03484364
SponsorWashington State University
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Self-reported physician diagnosis of hypertension confirmed by a prescription for an anti-hypertensive medication
Self-reported NHPI race
Age 18 years and older at enrollment
Measured systolic BP 140 mmHg on enrollment
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
Living in a household with someone who is enrolled in the study
Criteria also applies to the family member identified as the support person
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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