Food Insecurity, Hypertension
Conditions
Keywords
Food as medicine
Brief summary
Development of a user centered design to understand how a tailored food is medicine program based on user preferences and needs improves engagement and clinical outcomes. The study will examine how patients, screened either face to face or through automated for food insecurity, engage in a food is medicine program over 12-weeks.
Interventions
BEHAVIORALFood as Medicine Program
Grocery Prescription - participants will receive a card loaded with $100 per month to be used on the Instacart Fresh Funds program website/app or a SodaHealth grocery prescription card to be used inside a Kroger or Food City stores. Patients who select grocery delivery where Instacart is not available will receive Food City meals for the same value. or 2) Medically Tailored Meals (MTM) - participants receive approximately 5 frozen meals per week from Mom's Meals that follow an approved diet for those with hypertension. Participants will complete screening questions (screening decision tree attached) after informed consent to determine which food package the participant will receive. The screening decision tree is a tool that asks about kitchen availability for preparing foods, skills, and access to transportation. Depending on how the patient answers they will receive either grocery prescription or MTM for 3-months or 12-weeks.
OTHERSurvey
Participants answering "no" to assistance but agreeing to the 20-30 minute survey will receive a direct link to a survey related to reasons for not wanting assistance to answer questions at one time point.
Sponsors
Alison Gustafson
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The intervention consisted of allocating patients to receive either medically tailored meals or grocery Rx program based on their preferences and resource constraints.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Hypertension in last 12 months * Experiencing food insecurity as indicated by 2-item Hunger Vital Sign * English or Spanish speaking * No plans to move from the area for at least 1 year * Willing and able to accept text messages * Free living to the extent that participant has control over dietary intake * Willing and able to provide written informed consent and participate in all study activities.
Exclusion criteria
* Participant in weight research intervention in last 12 months * Considering bariatric surgery in the next year or prior bariatric surgery * Lack of safe, stable residence and ability to store meals * Lack of telephone which can receive text messages * Pregnancy/breastfeeding or intended pregnancy in the next year * Known drug or alcohol misuse in the past 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Systolic Blood Pressure | Baseline and week 12 | captured from the electronic medical record |
| Change Diastolic Blood Pressure | Baseline and week 12 | captured from the electronic medical record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dietary Intake | Baseline and week 12 | Dietary intake is captured with the Dietary Screener Questionnaire (DSQ-10). Responses to these dietary intake questions are converted to daily cup equivalent estimates (e.g., 1.2 cups of vegetables per day, 1.1 cups of fruit per day, 2.3 cups of FVs per day) of daily FV intake. The 2020-2025 United States Dietary Guidelines for Americans recommend consuming 2 to 3 cups of vegetables per day and 1.5 to 2 cups of fruit per day. |
| Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question | Baseline | The one item Gretchen Swanson Nutrition Security question will be asked as follows:In the past month, how often did the participant worry that the food bought wouldn't provide enough nutrients for the family, even if the participant had enough to eat? Response options are never, rarely, sometimes, often, always, don't know. We collapsed the categories of never/rarely; sometimes; often/always; don't know based on distribution of the data. |
| Number of Participants Reporting Food Insecurity | Baseline | USDA 6-item food insecurity survey Scores range from 0-6 with higher scores equating to lower food security. Categories were created with low, marginal, and very low based on USDA scoring algorithm. Food security status is assigned as follows: * Raw score 0-1-High or marginal food security (raw score 1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score zero on the six-item scale) * Raw score 2-4-Low food security * Raw score 5-6-Very low food security For some reporting purposes, the food security status of households with raw score 0-1 is described as food secure and the two categories "low food security" and "very low food security" in combination are referred to as food insecure. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlison Gustafson, PhD, MPH, RD
University of Kentucky
Participant flow
Pre-assignment details
Comparator Arm participants (participants answering "no to assistance but agreeing to the 20-30 minute survey) were not considered enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52.39 years STANDARD_DEVIATION 0.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 144 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 111 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 117 |
| other Total, other adverse events | 0 / 34 | 0 / 117 |
| serious Total, serious adverse events | 0 / 34 | 0 / 117 |
Outcome results
None listed