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| Name | Class |
|---|---|
| Maryland Department of Health and Mental Hygiene | OTHER_GOV |
| Maryland Cigarette Restitution Fund | OTHER_GOV |
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The goal of this study is to understand the best practices for implementing produce prescriptions among adults with overweight or obesity experiencing nutrition insecurity. Enrolled participants will receive an 8-week intervention aimed at increasing nutrition knowledge, self-efficacy for healthy eating, and barriers to healthy food access. Participants will be randomly assigned to one of two produce prescription implementation strategies:
Program 1: Participants will receive weekly produce vouchers that are redeemable at a local vendor.
Program 2. Participants will receive fresh produce delivered directly to the participant's home. These boxes will be tailored based on household size, cooking and preparation preferences, and produce the participant prefers to receive.
Researchers will compare engagement in and adherence to the intervention and the patterns of difference in 8-week changes in fruit and vegetable consumption and weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Produce Voucher | Experimental | Behavioral Text Message Program + Produce Voucher |
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| Produce Boxes | Experimental | Behavioral Text Message Program + Produce Box Delivery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Text Messages and Produce Box Delivery | Behavioral | Participants will receive a produce box delivered weekly to the participants home customized based on the participants cooking preferences and household size. Participants will also receive a daily text message aimed to support a healthy diet and lifestyle. These texts will include information to build participants' knowledge and skills for healthy eating. The participants will also include weekly goals that focus on eating a healthy diet. Participants will receive automated, personalized feedback via text messages based on participant goal attainment and daily responses. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reached | The investigators will track the number of number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained. | From screening up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Nutrition Insecurity as Assessed by the 4-item Nutrition Security Screening Questionnaire | Nutrition insecurity will be assessed using Center for Nutrition Health and Impact questionnaire with a 4-item scale. The higher the score, the greater the level of food security and control an individual has over their nutrition. The four items within the measure are scored from 0 to 4. Then, the measure's score is simply the mean of the responses. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hailey Miller Assistant Professor, RN, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Market | Baltimore | Maryland | 21205 | United States |
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The recruitment and screening processes will be conducted at the Northeast Market. During interactions with community members, the research team will inform individuals of the current study and if interested, help them complete initial screening forms. If the individual remains eligible and interested, a nurse will complete the screening, including measuring height and weight, in a semi-private space at the market.
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| ID | Title | Description |
|---|---|---|
| FG000 | Produce Boxes | Participants will receive fresh produce delivered directly to their home. These boxes will be tailored based on household size, cooking and preparation preferences, and produce they prefer to receive. The research team will partner with Hungry Harvest, an organization that will assemble and deliver the produce boxes. Hungry Harvest will also help collect participant information, such as delivery instructions, allergies, etc., and send out text messages to participants once they are enrolled, when their box is in route, and once their box is delivered each week. Participants will receive either a box that feeds a family of 1-2 each week, or a box that feeds a family of 3-4, based on their household size and box options provided by Hungry Harvest. Additionally, participants can choose between a standard box with food items that require some light-cooking, or a snacking box with ready-to-eat food items that require no cooking or kitchen preparation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2025 |
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| Behavioral Text Message Program and Produce Voucher | Behavioral | Participants will receive a weekly produce voucher redeemable at a local market vendor for fresh produce of the participant's choice. Participants will also receive a daily text message aimed to support a healthy diet and lifestyle. These texts will include information to build participants' knowledge and skills for healthy eating. The participants will also include weekly goals that focus on eating a healthy diet. Participants will receive automated, personalized feedback via text messages based on goal attainment and daily responses. |
|
| Baseline to 8 weeks |
| Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT) | Consumption of food groups will be assessed using the 9-item Mini-Eating Assessment Tool (EAT) questionnaire. Evaluates consumption of key food groups. Fruit and vegetable consumption were each based on two questions within the MINI eat scale, not subscales. Fruit ranges from 1 to 7 where 1 = less than 1 serving per week, and 7 = 4 or more servings per day. Vegetables range from 1 to 6 where 1 = less than 3 servings per week, and 6 = 4 or more servings per day. Mini-EAT score range 0-90. Higher scores better consumption. | Baseline, 4 weeks, and 8 weeks |
| Weight (kg) | Weight will be taken by study staff and measured to the nearest 0.1 kg. | Baseline, 8 weeks |
| Blood Pressure (mmHg) | Blood pressure was measured using the Omron 10 Series ® Upper Arm Blood Pressure Monitor. Participants were instructed to rest for five minutes before two blood pressure readings were taken on the upper arm, one minute apart. Measurements were averaged for analysis. | Baseline, 8 Weeks |
| Health Self-Efficacy as Assessed by the 11-item Healthy Eating and Weight Self-Efficacy Scale | Self-efficacy was measured using the 11-item Healthy Eating and Weight Self-Efficacy Scale. Responses were rated on a Likert scale that ranged from "Strongly Disagree" to "Strongly Agree". Responses were summed to create a total score ranging from 11 to 55, with higher scores representing greater self-efficacy. | Baseline, 8 weeks |
| FG001 | Produce Vouchers | Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size. |
| 4 Week Survey |
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| 8 Week Survey |
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| 8 Week Visit |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Produce Boxes | Participants will receive fresh produce delivered directly to their home. These boxes will be tailored based on household size, cooking and preparation preferences, and produce they prefer to receive. The research team will partner with Hungry Harvest, an organization that will assemble and deliver the produce boxes. Hungry Harvest will also help collect participant information, such as delivery instructions, allergies, etc., and send out text messages to participants once they are enrolled, when their box is in route, and once their box is delivered each week. Participants will receive either a box that feeds a family of 1-2 each week, or a box that feeds a family of 3-4, based on their household size and box options provided by Hungry Harvest. Additionally, participants can choose between a standard box with food items that require some light-cooking, or a snacking box with ready-to-eat food items that require no cooking or kitchen preparation. |
| BG001 | Produce Vouchers | Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reached | The investigators will track the number of number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained. | There were 221 individuals who were screened and completed the eligibility survey for the study. | Posted | Count of Participants | Participants | From screening up to 8 weeks |
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| Secondary | Nutrition Insecurity as Assessed by the 4-item Nutrition Security Screening Questionnaire | Nutrition insecurity will be assessed using Center for Nutrition Health and Impact questionnaire with a 4-item scale. The higher the score, the greater the level of food security and control an individual has over their nutrition. The four items within the measure are scored from 0 to 4. Then, the measure's score is simply the mean of the responses. | The number of participants analyzed in 8-week nutrition security is less than the baseline due to participants being lost to follow up. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline to 8 weeks |
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| Secondary | Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT) | Consumption of food groups will be assessed using the 9-item Mini-Eating Assessment Tool (EAT) questionnaire. Evaluates consumption of key food groups. Fruit and vegetable consumption were each based on two questions within the MINI eat scale, not subscales. Fruit ranges from 1 to 7 where 1 = less than 1 serving per week, and 7 = 4 or more servings per day. Vegetables range from 1 to 6 where 1 = less than 3 servings per week, and 6 = 4 or more servings per day. Mini-EAT score range 0-90. Higher scores better consumption. | Participants with data collected | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 4 weeks, and 8 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Weight (kg) | Weight will be taken by study staff and measured to the nearest 0.1 kg. | The number of participants analyzed in the 8-week measurement is less than the baseline due to participants being lost to follow up. | Posted | Median | Inter-Quartile Range | Kilograms (kg) | Baseline, 8 weeks |
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| Secondary | Blood Pressure (mmHg) | Blood pressure was measured using the Omron 10 Series ® Upper Arm Blood Pressure Monitor. Participants were instructed to rest for five minutes before two blood pressure readings were taken on the upper arm, one minute apart. Measurements were averaged for analysis. | The number of participants analyzed in 8-week measurement is less than the baseline due to participants being lost to follow up. | Posted | Median | Inter-Quartile Range | mmHg | Baseline, 8 Weeks |
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| Secondary | Health Self-Efficacy as Assessed by the 11-item Healthy Eating and Weight Self-Efficacy Scale | Self-efficacy was measured using the 11-item Healthy Eating and Weight Self-Efficacy Scale. Responses were rated on a Likert scale that ranged from "Strongly Disagree" to "Strongly Agree". Responses were summed to create a total score ranging from 11 to 55, with higher scores representing greater self-efficacy. | The number of participants analyzed in 8-week measurement is less than the baseline due to participants being lost to follow up. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 8 weeks |
|
From enrollment up to 8 week visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Produce Boxes | Participants will receive fresh produce delivered directly to their home. These boxes will be tailored based on household size, cooking and preparation preferences, and produce they prefer to receive. The research team will partner with Hungry Harvest, an organization that will assemble and deliver the produce boxes. Hungry Harvest will also help collect participant information, such as delivery instructions, allergies, etc., and send out text messages to participants once they are enrolled, when their box is in route, and once their box is delivered each week. Participants will receive either a box that feeds a family of 1-2 each week, or a box that feeds a family of 3-4, based on their household size and box options provided by Hungry Harvest. Additionally, participants can choose between a standard box with food items that require some light-cooking, or a snacking box with ready-to-eat food items that require no cooking or kitchen preparation. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG001 | Produce Vouchers | Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size. | 0 | 25 | 1 | 25 | 0 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| The participant fell and broke their leg. | Social circumstances | Non-systematic Assessment | The participant reported falling and breaking a leg and injuring their arm that required hospitalization. The event was not related to the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hailey Miller | Johns Hopkins University | N/A | hmille45@jhu.edu |
| Feb 5, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| OG001 | Produce Vouchers | Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size. |
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| OG001 | Produce Vouchers | Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size. |
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Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size.
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| OG001 |
| Produce Vouchers |
Participants will receive weekly produce vouchers that are redeemable at a local vendor at Northeast Market. The vouchers will be eligible to redeem approximately $20 worth of produce, depending on household size. |
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