Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

NCT07031739 | Recruiting DMC

• 2 other identifiers: IRB001157421R01HL173064-01A1
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Keywords

cardiovascular disease; hypertension; Food insecurity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Health-related quality of life Score

  Month 9

• Number of Changes in Community resource Use

  Month 9

Other Outcomes (6)

• Change in Food expenditure Amount

  Month 9

• Adherence Rate to medically tailored meal consumption (MTM)

  Month 3

• Change in Depressive symptoms Score

  Month 9

Study Arms (3)

Resource information

EXPERIMENTAL

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

Community Health Worker (CHW) assistance

EXPERIMENTAL

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

Medically-tailored Meals (MTM)

EXPERIMENTAL

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)

Interventions

Medically-tailored Meals (MTM) 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.

Also known as: meals are planned by a registered dietician

Medically-tailored Meals (MTM)

Resource information BEHAVIORAL

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

Also known as: information about local food resources

Resource information

Community Health Worker (CHW) assistance 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.

Also known as: community advocates

Community Health Worker (CHW) assistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 42061553 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension

Interventions

Community Health Workers; Insemination, Artificial, Heterologous

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services; Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Deepak Palakshappa, MD, MSHP

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Stone, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 community health workers (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 medically tailored meals (MTM).

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 22, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)