Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity (SMART)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Uncontrolled Hypertension
• Intervention / Treatment: Behavioral: Resource information; Behavioral: Community Health Worker (CHW) assistance; Behavioral: Medically-tailored Meals (MTM)

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.

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Stone, MPH; Phone Number: 336-713-5544; Email: Rebecca.J.Stone@Advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Principal Investigator: Deepak Palakshappa, MD, MSHP
      • Contact: Rebecca Stone, MPH; Phone Number: 336-713-5544; Email: Rebecca.J.Stone@Advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Behavioral: Resource information; Participants randomized to this arm will receive a tailored list of information about community resources.; Other Names: information about local food resources
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.	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.; Other Names: community advocates
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.	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.; Other Names: meals are planned by a registered dietician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure value	Systolic blood pressure measured as mmHg	Month 9
Diastolic blood pressure value	Diastolic blood pressure measured as mmHg	Month 9
Dietary Approaches to Stop Hypertension (DASH) diet adherence Score	Change in DASH diet adherence over time, based on the Mellen DASH diet adherence index - The Mellen DASH diet index is a nutrient-based method for assessing adherence to the Dietary Approaches to Stop Hypertension (DASH) diet. It uses nine key nutrients to determine a score ranging from 0 to 9, with 9 indicating the most adherence - Food items on the FFQ are assigned to 7 DASH food groups and 3 components using the Harvard nutrient database. Servings in each component are scored 0, 0.5, and 1. The DASH diet adherence score ranges from 0 to 10 and is the sum of the 10 component scores. Higher scores indicate greater diet concordance.	Month 9
Medication adherence Score	Change in medication adherence based on the 12-item Adherence to Refills and Medications Scale - The 12-item Adherence to Refills and Medications Scale (ARMS) is a self-report questionnaire designed to measure a patient's adherence to medication regimens - Each scale comprises five items that are scored on a Likert-type scale, where 1 = strongly disagree, 2 = disagree, 3 = uncertain, 4 = agree and 5 = strongly agree. Higher scores indicate stronger beliefs in the necessity of medication and greater concerns about taking it.	Month 9
Food Security Score	Change in food security over time based on the 10-item USDA Food Security Survey Module with a 30-day reference period - The USDA Food Security Survey Module (HFSSM) uses a 10-item adult-referenced module to assess food security status. A raw score is calculated based on affirmative responses to these 10 questions, and this score is then used to classify households into food security categories: high, marginal, low, or very low. High Food Security (Raw Score 0): No affirmative responses. Marginal Food Security (Raw Score 1-2): One or two affirmative responses. Low Food Security (Raw Score 3-5): Three to five affirmative responses. Very Low Food Security (Raw Score 6-10): Six to ten affirmative responses.	Month 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life Score	Change in EQ-5D-5L scores - assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score from 5 (11,111, no problems on any dimension) to 25 (55,555, extreme problems on all dimensions)	Month 9
Number of Changes in Community resource Use	Changes in use of community resources (e.g. food pantries, supplemental nutrition assistance program)	Month 9

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Food expenditure Amount	Out-of-pocket monthly food expenditures	Month 9
Adherence Rate to medically tailored meal consumption (MTM)	Food consumption diaries -Adherence to medically tailored meals	Month 3
Change in Depressive symptoms Score	Change in depressive symptoms based on the Patient Health Questionnaire-8 (PHQ-8) over time - PHQ-8 Scoring The Patient Health Questionnaire-8 (PHQ-8) is a screening tool used to assess the severity of depressive symptoms. Scoring Instructions: Each question is rated on a scale of 0 (not at all) to 3 (nearly every day). Add up the scores for all 8 questions. The total score ranges from 0 to 24. Interpretation: 0-4: No significant symptoms of depression. 5-9: Mild depression. 10-14: Moderate depression. 15-19: Moderately severe depression. 20-24: Severe depression.	Month 9
Change in Stress Score	Change in stress based on the Change in stress based on the Perceived Stress Scale scores - The Perceived Stress Scale (PSS) score provides insights into an individual's perceived stress levels. Higher scores generally indicate greater perceived stress, while lower scores suggest lower stress. The PSS-10, a shortened version of the PSS, ranges from 0 to 40, with scores typically categorized as low (0-13), moderate (14-26), and high (27-40) stress.	Month 9
Change in Hypertension (HTN) management Score	Change in scores in hypertension self-management behaviors based on the HTN self-care profile - The Hypertension Self-Care Profile (HBP SCP) is a questionnaire used to assess an individual's self-care behaviors related to managing hypertension. It's a multi-scale instrument, meaning it includes different sections to assess different aspects of self-care, including behavior, motivation, and self-efficacy - A high score on the HBP SCP generally indicates that an individual is actively engaged in self-care behaviors that are important for managing hypertension, has a strong motivation to engage in these behaviors, and has a high degree of confidence in their ability to manage their condition.	Month 9
Change in Number of Healthcare uses	The measure will assess differences in the number of missed appointments, emergency department use, and hospitalizations from baseline to follow at 3, 6 and 9 months. The study will assess differences in the number of missed appointments and visits between the arms	Months 3, 6, and 9

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Deepak Palakshappa, MD, MSHP, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Palakshappa D, Stone RJ, Torres JB, Berkowitz SA, Rhodes SD, Kirkendall ES, Dressler EV, Paredes Acosta LM, Williamson JD, Ard J, Ramirez B, Bundy R, Caudill N, Martin H, Hodge LD, Damon A, Caicedo-Dussan L, Rigdon J. Protocol for the sequential multiple assignment randomized trial to reduce food insecurity and improve adherence in patients with hypertension (SMART-FI). Contemp Clin Trials. 2026 Apr 28:108331. doi: 10.1016/j.cct.2026.108331. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: June 5, 2025
• First Submitted That Met QC Criteria: June 12, 2025
• First Posted (Actual): June 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: hypertension; cardiovascular disease; Food insecurity
• Additional Relevant MeSH Terms: Vascular Diseases; Hypertension; Cardiovascular Diseases; Investigative Techniques; Therapeutics; Health Care Facilities Workforce and Services; Health Personnel; Reproductive Techniques, Assisted; Reproductive Techniques; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Insemination, Artificial; Insemination; Allied Health Personnel; Insemination, Artificial, Heterologous; Community Health Workers
• Other Study ID Numbers: IRB00115742; 1R01HL173064-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No