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ENACTS Intervention for High Blood Pressure (ENACTS Trial)

N/A
Recruiting
Led By denise dillard
Research Sponsored by Washington State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Age 18 years and older at enrollment
Must not have
Currently undergoing dialysis or treatment for a terminal illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effects of the ENACTS intervention on blood pressure and related outcomes to a control group. The intervention will also be evaluated for its ability to influence grocery store policy on clearly identifying low sodium or high potassium foods.

Who is the study for?
The ENACTS trial is for Native Hawaiian/Pacific Islander adults with high blood pressure or type 2 diabetes. Participants must have internet access, speak English, and be willing to follow the study's rules. They can't join if they're pregnant, planning pregnancy, on dialysis, or receiving treatment for a terminal illness.
What is being tested?
ENACTS aims to lower blood pressure (BP) in individuals and their family supporters by promoting low-sodium/high-potassium diets through policy changes at grocery stores. It tests these interventions' effectiveness at individual, family, and policy levels.
What are the potential side effects?
Since ENACTS focuses on dietary guidance and policy change rather than medication or medical procedures, it may not have direct side effects like drugs do; however lifestyle changes could indirectly cause stress or require significant adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with hypertension or type 2 diabetes and take medication for it.
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I am 18 years old or older.
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I have been diagnosed with hypertension or type 2 diabetes and take medication for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am on dialysis or receiving treatment for a terminal illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Systolic Blood Pressure
Secondary study objectives
Daily Energy Expenditure
Eating Behaviors
Food Purchasing
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
The ENACTS intervention is four peer-facilitated educational classes delivered over 8 weeks focused on hypertension self-management.
Group II: Waitlist GroupActive Control1 Intervention
Usual care and $50 in groceries every other week for 8 weeks.

Find a Location

Who is running the clinical trial?

Washington State UniversityLead Sponsor
108 Previous Clinical Trials
57,298 Total Patients Enrolled
denise dillardPrincipal InvestigatorWashington State University
Ka'imi A Sinclair, PhD, MPHPrincipal InvestigatorWashington State University

Media Library

ENACTS Clinical Trial Eligibility Overview. Trial Name: NCT03484364 — N/A
High Blood Pressure Research Study Groups: Waitlist Group, Intervention Group
High Blood Pressure Clinical Trial 2023: ENACTS Highlights & Side Effects. Trial Name: NCT03484364 — N/A
ENACTS 2023 Treatment Timeline for Medical Study. Trial Name: NCT03484364 — N/A
~3 spots leftby Dec 2024
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