RECRUITING

Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-18
Study Completion:2030-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07031739

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must Speak English or Spanish
  2. * have a diagnosis of Hypertension (HTN)
  3. * prescribed at least one blood pressure lowering medication (including thiazide diuretic, calcium channel blocker, beta-blocker, angiotensin-converting enzyme inhibitors, or angiotensin receptor blocker)
  4. * past 2 blood pressures at their primary care doctor were greater than 130/80mmHg (millimeters of Mercury)
  5. * seen by their primary care doctor in the past 6 months
  6. * experience Food Insecurities (FI) based on the 2-item Hunger Vital Sign
  1. * Systolic Blood Pressure \> 210mmHg or a diastolic blood pressure \> 120mmHg
  2. * 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)
  3. * pregnant, breastfeeding, or planning to become pregnant in the next 6 months
  4. * planning on moving out of the area within 6 months
  5. * lack safe stable housing
  6. * do not have the ability to store meals
  7. * lack of a telephone

Contacts and Locations

Study Contact

Rebecca Stone, MPH
CONTACT
336-713-5544
rjstone@wakehealth.edu

Principal Investigator

Deepak Palakshappa, MD, MSHP
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Deepak Palakshappa, MD, MSHP, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-18
Study Completion Date2030-02

Study Record Updates

Study Start Date2025-08-18
Study Completion Date2030-02

Terms related to this study

Keywords Provided by Researchers

  • cardiovascular disease
  • hypertension
  • Food insecurity

Additional Relevant MeSH Terms

  • Uncontrolled Hypertension