Overweight and ObesityNCT06751563
Study of Produce Prescription Programs in Adults With Overweight or Obesity Experiencing Nutrition Insecurity
A study testing Behavioral Text Messages and Produce Box Delivery and Behavioral Text Message Program and Produce Voucher in people with Overweight and Obesity, run by Johns Hopkins University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Behavioral Text Messages and Produce Box Delivery and Behavioral Text Message Program and Produce Voucher
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2025to 6 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 years of age or older
- Living with overweight or obesity, defined as a BMI ≥25
- Screens positive for nutrition insecurity
- Has a smartphone with a data plan
- Willing to receive daily text messages
- Has an address that can receive delivery
- Can read and write in English
- Is willing to pick up produce at the Northeast Market
Who cannot join
- Participating in another related research study
- Currently taking weight loss drugs
- Cardiovascular disease event in the last 6 months
- Active cancer
- Recent hospitalization due to psychiatric condition or event
- Pregnancy or planned during the study period
Show all 11Show fewer
- Currently breastfeeding
- Documented dementia
- On kidney dialysis
- Planned or recent bariatric surgery
- Weight exceeding 440 lbs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Pilot Study of Produce Prescription Programs in Adults With Overweight or Obesity Experiencing Nutrition Insecurity
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.
Read more
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.
- Conditions
- Overweight and Obesity
- Being tested
- Behavioral Text Messages and Produce Box Delivery, Behavioral Text Message Program and Produce Voucher
- Keywords
- obesity, overweight, produce prescription, produce voucher, nutrition, nutrition security
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Text Messages and Produce Box DeliveryBehavioural
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.
Behavioral Text Message Program and Produce VoucherBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Produce Voucher | Experimental | Behavioral Text Message Program + Produce Voucher Receives: Behavioral: Behavioral Text Message Program and Produce Voucher |
| Produce Boxes | Experimental | Behavioral Text Message Program + Produce Box Delivery Receives: Behavioral: Behavioral Text Messages and Produce Box Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From screening up to 8 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: Baseline, 4 weeks, and 8 weeks
Weight (kg)
Weight will be taken by study staff and measured to the nearest 0.1 kg.
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start8 Jan 2025
- Primary completion4 Apr 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Maryland Department of Health and Mental Hygiene, Maryland Cigarette Restitution Fund
- Responsible party
- Sponsor
- Investigators
- Hailey Miller Assistant Professor, RN, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751563
- Sponsor's protocol ID
- IRB00463007
- Status last verified
- Jun 2026
- First submitted
- 20 Dec 2024
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study of Produce Prescription Programs in Adults With Overweight or Obesity Experiencing Nutrition Insecurity
- ClinicalTrials.gov ID
- NCT06751563
- Acronym / sponsor ID
- IRB00463007
- Conditions
- Overweight and Obesity
- Keywords
- obesity, overweight, produce prescription, produce voucher, nutrition, nutrition security
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Maryland Department of Health and Mental Hygiene, Maryland Cigarette Restitution Fund
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 30 Dec 2024 (actual)
- Results
- Posted 6 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Produce Voucher | Experimental | Behavioral: Behavioral Text Message Program and Produce VoucherBehavioral Text Message Program + Produce Voucher |
| Produce Boxes | Experimental | Behavioral: Behavioral Text Messages and Produce Box DeliveryBehavioral Text Message Program + Produce Box Delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult 18 years of age or older
- Living with overweight or obesity, defined as a BMI ≥25
- Screens positive for nutrition insecurity
- Has a smartphone with a data plan
- Willing to receive daily text messages
Key exclusion criteria (11 listed)
- Participating in another related research study
- Currently taking weight loss drugs
- Cardiovascular disease event in the last 6 months
- Active cancer
- Recent hospitalization due to psychiatric condition or event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Text Messages and Produce Box DeliveryParticipants 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. | Behavioural | Produce Boxes |
| Behavioral Text Message Program and Produce VoucherParticipants 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. | Behavioural | Produce Voucher |
Primary outcome
Number of Participants Reached
Time frame: From screening up to 8 weeks
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.
5 secondary outcomes
Nutrition Insecurity as Assessed by the 4-item Nutrition Security Screening Questionnaire
Time frame: Baseline to 8 weeks
Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT)
Time frame: Baseline, 4 weeks, and 8 weeks
Weight (kg)
Time frame: Baseline, 8 weeks
Blood Pressure (mmHg)
Time frame: Baseline, 8 Weeks
Health Self-Efficacy as Assessed by the 11-item Healthy Eating and Weight Self-Efficacy Scale
Time frame: Baseline, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hailey Miller Assistant Professor, RN, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Text Messages and Produce Box Delivery and Behavioral Text Message Program and Produce Voucher in people with Overweight and Obesity, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reached (time frame: From screening up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.