Engaging Native Hawaiian/Pacific Islanders and Activating Communities to Take Steps (ENACTS) (ENACTS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03484364|
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : May 27, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: ENACTS||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- Systolic Blood Pressure [ Time Frame: 6 months ]Auscultated blood pressure
- Sodium Potassium Urinary levels [ Time Frame: 6 months ]24 hour urine collection
- Eating Behaviors [ Time Frame: 6 months ]24 hour dietary recall
- Food Purchasing [ Time Frame: 6 months ]Grocery receipts
- Medication Adherence [ Time Frame: 6 months ]Hill Bone High Blood Pressure Compliance Scale
- Social Support [ Time Frame: 6 months ]Family care climate questionnaire
- Tobacco Use [ Time Frame: 6 months ]National Health Interview Survey
- Daily Energy Expenditure [ Time Frame: 6 months ]International Physical Activity Questionnaire (IPAQ)
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
|Contact: Ka'imi A Sinclair, PhD, MPHfirstname.lastname@example.org|
|Contact: Katie Nelson, BSemail@example.com|
|United States, Washington|
|Asian Counseling and Referral Service||Recruiting|
|Seattle, Washington, United States, 98144|
|Contact: Polu Masaniai|
|Principal Investigator:||Ka`imi A Sinclair, PhD, MPH||Washington State University|