Clinical trial NCT03484364: Engaging Native Hawaiian/Pacific Islanders and Activating Communities to Take Steps (ENACTS)
Official title: Engaging Native Hawaiian/Pacific Islanders and Activating Communities to Take Steps (ENACTS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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;

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 6 months
Secondary outcomes:
measure: Eating Behaviors
timeFrame: 6 months
measure: Food Purchasing
timeFrame: 6 months
measure: Medication Adherence
timeFrame: 6 months
measure: Social Support
timeFrame: 6 months
measure: Tobacco Use
timeFrame: 6 months
measure: Daily Energy Expenditure
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: National Recruitment via Facebook and Internet
state: Washington
Study officials:
affiliation: Washington State University
name: denise dillard
role: PRINCIPAL_INVESTIGATOR
References: