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Trial record 1 of 3 for:    native hawaiian | Recruiting Studies | United States
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Engaging Native Hawaiian/Pacific Islanders and Activating Communities to Take Steps (ENACTS) (ENACTS)

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ClinicalTrials.gov Identifier: NCT03484364
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ka'imi Sinclair, Washington State University

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: ENACTS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Engaging Native Hawaiian/Pacific Islanders and Activating Communities to Take Steps (ENACTS)
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
The ENACTS intervention is eight weeks of peer-facilitated educational classes about hypertension self-management and autonomous support from family or friend enrolled as support person.
Behavioral: ENACTS
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. $30 of groceries for 8 weeks.

No Intervention: Waitlist Group
Usual care and $30 in groceries each week for 8 weeks.



Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: 6 months ]
    Auscultated blood pressure


Secondary Outcome Measures :
  1. Sodium Potassium Urinary levels [ Time Frame: 6 months ]
    24 hour urine collection

  2. Eating Behaviors [ Time Frame: 6 months ]
    24 hour dietary recall

  3. Food Purchasing [ Time Frame: 6 months ]
    Grocery receipts

  4. Medication Adherence [ Time Frame: 6 months ]
    Hill Bone High Blood Pressure Compliance Scale

  5. Social Support [ Time Frame: 6 months ]
    Family care climate questionnaire

  6. Tobacco Use [ Time Frame: 6 months ]
    National Health Interview Survey

  7. Daily Energy Expenditure [ Time Frame: 6 months ]
    International Physical Activity Questionnaire (IPAQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484364


Contacts
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Contact: Ka'imi A Sinclair, PhD, MPH 206-708-8633 kaimi.sinclair@wsu.edu
Contact: Katie Nelson, BS 2067088604 katie.nelson@wsu.edu

Locations
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United States, Washington
Asian Counseling and Referral Service Recruiting
Seattle, Washington, United States, 98144
Contact: Polu Masaniai         
Sponsors and Collaborators
Washington State University
Investigators
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Principal Investigator: Ka`imi A Sinclair, PhD, MPH Washington State University
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Responsible Party: Ka'imi Sinclair, Associate Professor, Washington State University
ClinicalTrials.gov Identifier: NCT03484364    
Other Study ID Numbers: U54MD011240 127687
U54MD011240 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases