Trial Outcomes & Findings for Food Insecurity, Food as Medicine, Hypertension (NCT NCT07011251)

NCT ID: NCT07011251

Last Updated: 2026-04-01

Results Overview

captured from the electronic medical record

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

159 participants

Primary outcome timeframe

Baseline and week 12

Results posted on

2026-04-01

Participant Flow

Comparator Arm participants (participants answering "no to assistance but agreeing to the 20-30 minute survey) were not considered enrolled.

Participant milestones

Participant milestones
Measure
Food is Medicine Program - Medically Tailored Meals
Patients were screened for food insecurity either face to face or automated based on standard of care practice at their respective healthcare site. Patients were referred to the study team to utilize a screening decision tool to allocate them to receive either Medically tailored meals or a grocery voucher program. Participants then received their program for 12-weeks. Participants then completed post intervention survey. Survey: 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.
Food Is Medicine Program - Grocery Prescription
Patients were screened for food insecurity either face to face or automated based on standard of care practice at their respective healthcare site. Patients were referred to the study team to utilize a screening decision tool to allocate them to receive either Medically tailored meals or a grocery voucher program. Participants then received their program for 12-weeks. Participants then completed post intervention survey. Survey: 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.
Overall Study
STARTED
37
122
Overall Study
COMPLETED
34
117
Overall Study
NOT COMPLETED
3
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Food is Medicine Program - Medically Tailored Meals
Patients were screened for food insecurity either face to face or automated based on standard of care practice at their respective healthcare site. Patients were referred to the study team to utilize a screening decision tool to allocate them to receive either Medically tailored meals or a grocery voucher program. Participants then received their program for 12-weeks. Participants then completed post intervention survey. Survey: 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.
Food Is Medicine Program - Grocery Prescription
Patients were screened for food insecurity either face to face or automated based on standard of care practice at their respective healthcare site. Patients were referred to the study team to utilize a screening decision tool to allocate them to receive either Medically tailored meals or a grocery voucher program. Participants then received their program for 12-weeks. Participants then completed post intervention survey. Survey: 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.
Overall Study
Lost to Follow-up
0
2
Overall Study
Death
1
2
Overall Study
Did not like food options
2
0
Overall Study
Uninterested after reading program information
0
1

Baseline Characteristics

Not all participants completed all baseline and post intervention data assessments.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Food is Medicine Program - Medically Tailored Meals
n=33 Participants
Patients were screened for food insecurity either face to face or automated based on standard of care practice at their respective healthcare site. Patients were referred to the study team to utilize a screening decision tool to allocate them to receive either Medically tailored meals or a grocery voucher program. Participants then received their program for 12-weeks. Participants then completed post intervention survey. Survey: 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.
Food Is Medicine Program - Grocery Prescription Total
n=111 Participants
Patients were screened for food insecurity either face to face or automated based on standard of care practice at their respective healthcare site. Patients were referred to the study team to utilize a screening decision tool to allocate them to receive either Medically tailored meals or a grocery voucher program. Participants then received their program for 12-weeks. Participants then completed post intervention survey. Survey: 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.
Total
n=144 Participants
Total of all reporting groups
Age, Continuous
53.42 years
STANDARD_DEVIATION 1.49 • n=5 Participants • Not all participants completed all baseline and post intervention data assessments.
52.39 years
STANDARD_DEVIATION .87 • n=5 Participants • Not all participants completed all baseline and post intervention data assessments.
52.97 years
STANDARD_DEVIATION .9 • n=10 Participants • Not all participants completed all baseline and post intervention data assessments.
Sex: Female, Male
Female
18 Participants
n=5 Participants • Not all participants completed baseline assessments.
72 Participants
n=5 Participants • Not all participants completed baseline assessments.
90 Participants
n=10 Participants • Not all participants completed baseline assessments.
Sex: Female, Male
Male
15 Participants
n=5 Participants • Not all participants completed baseline assessments.
39 Participants
n=5 Participants • Not all participants completed baseline assessments.
54 Participants
n=10 Participants • Not all participants completed baseline assessments.
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants • Not all participants completed baseline assessments.
0 Participants
n=5 Participants • Not all participants completed baseline assessments.
0 Participants
n=10 Participants • Not all participants completed baseline assessments.
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants • Not all participants completed baseline assessments.
0 Participants
n=5 Participants • Not all participants completed baseline assessments.
0 Participants
n=10 Participants • Not all participants completed baseline assessments.
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants • Not all participants completed baseline assessments.
0 Participants
n=5 Participants • Not all participants completed baseline assessments.
0 Participants
n=10 Participants • Not all participants completed baseline assessments.
Race (NIH/OMB)
Black or African American
10 Participants
n=5 Participants • Not all participants completed baseline assessments.
14 Participants
n=5 Participants • Not all participants completed baseline assessments.
24 Participants
n=10 Participants • Not all participants completed baseline assessments.
Race (NIH/OMB)
White
23 Participants
n=5 Participants • Not all participants completed baseline assessments.
97 Participants
n=5 Participants • Not all participants completed baseline assessments.
120 Participants
n=10 Participants • Not all participants completed baseline assessments.
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants • Not all participants completed baseline assessments.
0 Participants
n=5 Participants • Not all participants completed baseline assessments.
0 Participants
n=10 Participants • Not all participants completed baseline assessments.
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants • Not all participants completed baseline assessments.
0 Participants
n=5 Participants • Not all participants completed baseline assessments.
0 Participants
n=10 Participants • Not all participants completed baseline assessments.
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
33 Participants
n=5 Participants
111 Participants
n=5 Participants
144 Participants
n=10 Participants
Region of Enrollment
United States
33 participants
n=5 Participants
111 participants
n=5 Participants
144 participants
n=10 Participants

PRIMARY outcome

Timeframe: Baseline and week 12

Population: Participants providing health outcomes at baseline and post intervention

captured from the electronic medical record

Outcome measures

Outcome measures
Measure
Food Is Medicine Program - Medically Tailored Meals (MTM)
n=33 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Food Is Medicine Program - Grocery Perscription
n=111 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Change Systolic Blood Pressure
9.39 mmHg
Interval -3.99 to 22.78
.25 mmHg
Interval -3.57 to 4.08

PRIMARY outcome

Timeframe: Baseline and week 12

Population: Participants providing health outcomes at baseline and post intervention

captured from the electronic medical record

Outcome measures

Outcome measures
Measure
Food Is Medicine Program - Medically Tailored Meals (MTM)
n=33 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Food Is Medicine Program - Grocery Perscription
n=111 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Change Diastolic Blood Pressure
5.45 mmHg
Interval -3.61 to 14.51
1.26 mmHg
Interval -1.16 to 3.69

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Participants providing health outcomes at baseline and post intervention

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.

Outcome measures

Outcome measures
Measure
Food Is Medicine Program - Medically Tailored Meals (MTM)
n=33 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Food Is Medicine Program - Grocery Perscription
n=111 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Change in Dietary Intake
Men
.49 cups per day
Interval 0.2 to 0.77
.24 cups per day
Interval 0.08 to 0.4
Change in Dietary Intake
Women
.24 cups per day
Interval 0.04 to 0.45
.22 cups per day
Interval 0.11 to 0.33

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Food Is Medicine Program - Medically Tailored Meals (MTM)
n=33 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Food Is Medicine Program - Grocery Perscription
n=111 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question
Never/Rarely
10 Participants
34 Participants
Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question
Sometimes
7 Participants
44 Participants
Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question
Often/Always
14 Participants
32 Participants
Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question
Don't know
2 Participants
1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Food Is Medicine Program - Medically Tailored Meals (MTM)
n=33 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Food Is Medicine Program - Grocery Perscription
n=111 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Number of Participants Reporting Food Insecurity
Low
6 Participants
2 Participants
Number of Participants Reporting Food Insecurity
Marginal
0 Participants
19 Participants
Number of Participants Reporting Food Insecurity
Very Low
27 Participants
90 Participants

SECONDARY outcome

Timeframe: 12 weeks

USDA 6-item food insecurity survey Scores range from 0-6 with higher scores equating to lower food security. 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.

Outcome measures

Outcome measures
Measure
Food Is Medicine Program - Medically Tailored Meals (MTM)
n=33 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Food Is Medicine Program - Grocery Perscription
n=111 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Number of Participants Reporting Food Insecurity
Low
5 Participants
1 Participants
Number of Participants Reporting Food Insecurity
Marginal
0 Participants
17 Participants
Number of Participants Reporting Food Insecurity
Very Low
28 Participants
93 Participants

SECONDARY outcome

Timeframe: 12 week

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.

Outcome measures

Outcome measures
Measure
Food Is Medicine Program - Medically Tailored Meals (MTM)
n=33 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Food Is Medicine Program - Grocery Perscription
n=111 Participants
Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items.
Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question
Don't know
3 Participants
9 Participants
Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question
Never/Rarely
9 Participants
34 Participants
Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question
Sometimes
3 Participants
38 Participants
Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question
Often/Always
18 Participants
30 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Outcome measures

Outcome data not reported

Adverse Events

Food is Medicine Program - Medically Tailored Meals

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Food Is Medicine Program - Grocery Prescription

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alison Gustafson

University of Kentucky

Phone: 859-257-1308

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place