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Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

Description

Food insecurity affects 20% of the 116 million people in the US with hypertension and is associated with poor adherence to evidence-based treatments and disparities in hypertension outcomes. Interventions are being used to address food insecurity in clinical care settings, but people differ in the support they need to reduce food insecurity and little is known about which food insecurity interventions work best, or for whom. The goal of this study is to develop and test an adaptive food insecurity intervention using a Sequential Multiple Assignment Randomized Trial to determine which initial food insecurity intervention is more effective in improving adherence and blood pressure in patients with hypertension and for those who do not respond to the initial intervention, evaluate how to best provide additional support.

Conditions

Uncontrolled Hypertension
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Related Conditions:

Uncontrolled Hypertension

Study Overview

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Study Details

Study overview

Food insecurity affects 20% of the 116 million people in the US with hypertension and is associated with poor adherence to evidence-based treatments and disparities in hypertension outcomes. Interventions are being used to address food insecurity in clinical care settings, but people differ in the support they need to reduce food insecurity and little is known about which food insecurity interventions work best, or for whom. The goal of this study is to develop and test an adaptive food insecurity intervention using a Sequential Multiple Assignment Randomized Trial to determine which initial food insecurity intervention is more effective in improving adherence and blood pressure in patients with hypertension and for those who do not respond to the initial intervention, evaluate how to best provide additional support.

Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity and Improve Adherence in Patients With Hypertension

Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

Condition
Uncontrolled Hypertension
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Must Speak English or Spanish
  • * have a diagnosis of Hypertension (HTN)
  • * prescribed at least one blood pressure lowering medication (including thiazide diuretic, calcium channel blocker, beta-blocker, angiotensin-converting enzyme inhibitors, or angiotensin receptor blocker)
  • * past 2 blood pressures at their primary care doctor were greater than 130/80mmHg (millimeters of Mercury)
  • * seen by their primary care doctor in the past 6 months
  • * experience Food Insecurities (FI) based on the 2-item Hunger Vital Sign
  • * Systolic Blood Pressure \> 210mmHg or a diastolic blood pressure \> 120mmHg
  • * have a severe cognitive impairment or major psychiatric illness that prevents consent or serious medical condition which either limits life expectancy or requires active management (e.g. certain cancers)
  • * pregnant, breastfeeding, or planning to become pregnant in the next 6 months
  • * planning on moving out of the area within 6 months
  • * lack safe stable housing
  • * do not have the ability to store meals
  • * lack of a telephone

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Deepak Palakshappa, MD, MSHP, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

2030-02