Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

NCT ID: NCT07031739

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2030-02-28

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.

Detailed Description

In the US, 47% of adults have hypertension (HTN), and HTN is the leading cause of cardiovascular disease morbidity and mortality. Uncontrolled HTN increases the risk of cardiovascular disease, chronic kidney disease, and cognitive impairment. Current guidelines recommend the adoption of a healthy diet as an integral part of ongoing treatment regardless of the underlying antihypertensive drug treatment. The Dietary Approaches to Stop Hypertension (DASH) eating pattern is a diet rich in fruits, vegetables, and whole grains with a reduced content of sodium and saturated fat. The DASH is the diet with the strongest evidence to be effective for lowering blood pressure. Despite the evidence base for the effectiveness of DASH as well as pharmacological treatments, economic factors are common barriers to individuals with HTN adhering to treatments. Adherence is multidimensional and involves initiation, implementation, and persistence. Food insecurity (FI), the lack of consistent access to the food needed for a healthy life, is an important factor that leads to HTN disparities. Individuals living in food insecure households are less likely to adhere to prescribed HTN treatments, such as DASH and medications, and more likely to have worse blood pressure control.

Because of the prevalence of FI and associated poor health outcomes, a growing number of health systems and health insurers are investing in integrating interventions to address FI as part of routine clinical care. These interventions include 1) providing information to patients about community resources), 2) utilizing community health workers (CHW), and 3) home delivery of medically tailored meals (MTM). Studies have shown these FI interventions have varying levels of success on improving food security and health. However, people often need varying levels of support to address needs, and, rather than using only one single intervention to address FI, there remains a gap in understanding whether adaptively allocating resources based on need has the potential to more effectively, equitably, and efficiently improve food security and health for a greater proportion of patients.

To advance the science in patient adherence and blood pressure management, this study will conduct a sequential multiple assignment randomized trial (SMART) among food-insecure patients with uncontrolled HTN. SMART uses experimental design principles to determine whether and how to alter treatments to build optimal adaptive interventions. This study will assess the change in adherence and blood pressure over time (0-9 months). This study will also evaluate if treatment options were more effective for particular patients. Several other measures are included in this study to learn more about how an adaptive intervention designed to address FI affects blood pressure, adherence, food security, health-related quality of life, and other key risk factors for blood pressure control in patients with HTN.

The proposed Sequential Multiple Assignment Randomized Trial to reduce Food Insecurity and Improve Adherence in Patients with Hypertension (SMART-FI) is a single-site, open-label, longitudinal two-stage SMART. 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 who do not have a 10mmHg improvement in systolic blood pressure (SBP) at 3 months will be re-randomized to one of two second-stage treatments for an additional 3 months: 1) CHW support or 2) home delivery of MTM. The study will recruit 224 participants for this trial. Participants will engage in the interventions up to 6 months and will be followed for a total of 9 months. In Aim 1, the study will determine which first-stage FI intervention is more effective in improving adherence and blood pressure. In Aim 2, the study will evaluate which FI intervention is the best next step for those who do not respond to the initial intervention. In Aim 3, the study will explore how, why, and under what circumstances participants achieved improvements to the first- and second-stage interventions by conducting semi-structured interviews with participants and evaluating for potential predictors of heterogeneity in response to each intervention.

Conditions

Uncontrolled Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Resource information

Intervention Type: BEHAVIORAL

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. As health advisors, CHW will help them overcome commonly experienced barriers in blood pressure management.

Group Type: EXPERIMENTAL

Community Health Worker (CHW) assistance

Intervention Type: BEHAVIORAL

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. All meals are planned by a registered dietician and based on the Dietary Approaches to Stop Hypertension (DASH) diet.

Group Type: EXPERIMENTAL

Medically-tailored Meals (MTM)

Intervention Type: BEHAVIORAL

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.

Interventions

Resource information

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

information about local food resources; community advocates; meals are planned by a registered dietician

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deepak Palakshappa, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rebecca Stone, MPH

Role: CONTACT

rjstone@wakehealth.edu

336-713-5544

Facility Contacts

Rebecca Stone, MPH

Role: primary

rjstone@wakehealth.edu

336-713-5544

Other Identifiers

1R01HL173064-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00115742

Identifier Type: -

Identifier Source: org_study_id