Recruiting

Food Insecurity Intervention

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07031739

Conditions

Uncontrolled Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Resource information

Community Health Worker (CHW) assistance

Medically-tailored Meals (MTM)

Study Details

Brief summary:

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

Study ID

NCT07031739

Start date

Aug 18, 2025

Status verified date

May, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Resource information

Participants randomized to this arm will receive a tailored list of information about community resources. The list will include information about local food resources (e.g. local food pantries) and government programs (e.g. Supplemental Nutrition Assistance Program) to address Food Insecurities (FI).

experimental: Community Health Worker (CHW) assistance

The CHW will meet with the participant at the baseline visit and will follow up with participants at least every other week. The CHW will also work directly with the patient's care team. As health advisors, CHW will help them overcome commonly experienced barriers in blood pressure management.

experimental: Medically-tailored Meals (MTM)

MTM will consist of weekly home meal delivery. During the 3 months, participants will receive 10 medically tailored refrigerated or frozen meals (5 lunches and 5 dinners) delivered to their home weekly. All meals are planned by a registered dietician and based on the Dietary Approaches to Stop Hypertension (DASH) diet.

Interventions

Resource information

Participants randomized to this arm will receive a tailored list of information about community resources.

Community Health Worker (CHW) assistance

The CHW will meet with the participant at the baseline visit and will follow up with participants at least every other week. The CHW will also work directly with the patient's care team.

Medically-tailored Meals (MTM)

MTM will consist of weekly home meal delivery. During the 3 months, participants will receive 10 medically tailored refrigerated or frozen meals (5 lunches and 5 dinners) delivered to their home weekly.

Primary outcome measure

  • Systolic blood pressure value [ Time Frame: Month 9 ]
  • Diastolic blood pressure value [ Time Frame: Month 9 ]
  • Dietary Approaches to Stop Hypertension (DASH) diet adherence Score [ Time Frame: Month 9 ]
  • Medication adherence Score [ Time Frame: Month 9 ]
  • Food Security Score [ Time Frame: Month 9 ]

Central Contacts and Locations

Central contacts

Rebecca Stone, MPH

336-713-5544Rebecca.J.Stone@Advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Rebecca Stone, MPH

336-713-5544Rebecca.J.Stone@Advocatehealth.org

Principal Investigator:

Deepak Palakshappa, MD, MSHP

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • cardiovascular disease
  • hypertension
  • Food insecurity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-05-06.