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Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months, 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be randomized to one of two first-stage treatments for 3 months: 1) information about community resources or 2) in-person CHW support."
  • "Participants will engage in the interventions up to 6 months and will be followed for a total of 9 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ways to help people with high blood pressure who have trouble getting enough food. It looks at which support works best to help people follow treatment and lower blood pressure, and what extra help to offer if the first support does not work.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Speak English or Spanish.
  • Have been diagnosed with high blood pressure.
  • Have a prescription for at least one medicine to lower blood pressure.
  • Have had blood pressure readings of at least 130/80 at your last two primary care visits.
  • Have seen your primary care doctor in the past 6 months.
  • Have trouble getting enough food, based on a two-question food needs check.

Who can't join

  • Have a blood pressure top number above 210 or bottom number above 120.
  • Have severe problems with thinking or memory, or a major mental illness, that prevent you from agreeing to join the study.
  • Have a serious medical condition that limits how long you may live or needs active care, such as certain cancers.
  • Are pregnant, breastfeeding, or planning to become pregnant in the next 6 months.
  • Plan to move out of the area within 6 months.
  • Do not have safe, stable housing.
  • Cannot store meals.
  • Do not have a telephone.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 or equal to130/80mmHg (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 Exclusion Criteria: * 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

Study sites (1)

NC