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.
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)
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
Sequential
Resource information
BehavioralParticipants randomized to this arm will receive a tailored list of information about community resources.
Community Health Worker (CHW) assistance
BehavioralThe 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)
BehavioralMTM 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.
Systolic blood pressure value
Systolic blood pressure measured as mmHg
Diastolic blood pressure value
Diastolic blood pressure measured as mmHg
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.
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.
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)
Number of Changes in Community resource Use
Changes in use of community resources (e.g. food pantries, supplemental nutrition assistance program)
Change in Food expenditure Amount
Out-of-pocket monthly food expenditures
Adherence Rate to medically tailored meal consumption (MTM)
Food consumption diaries -Adherence to medically tailored meals
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.
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.
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Wake Forest University Health Sciences
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
