Healthy DietNCT05672186
Mobile Food Market Cluster Randomized Trial
A study testing Full-service market intervention in people with Healthy Diet and Nutrition, Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
Mobile food markets have been proposed as a strategy for mitigating health disparities related to poor nutrition and diet/weight-related health conditions because they bring low-cost, healthy food directly to underserved populations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet, Nutrition, Healthy
- What is being tested?
- Full-service market intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2023to 24 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community sites (e.g., public housing hi-rise, low-income senior living residence) must meet the following criteria:
- locale for low-income populations that experience difficulty in accessing healthy, affordable foods (e.g., public housing residences; low-income senior housing) or a community center in a low-income, low-food access (0.5 mile) census tract;
- willingness to be randomized to the intervention or waitlist control;
- located over 0.5 miles apart from other trial sites;
- willingness to allow for recruitment and data collection to occur in onsite community rooms
- Participants must meet the following criteria:
Show all 12Show fewer
- being aged 18 years or older;
- identifying as the primary food shopper in their household;
- being able to speak English or ASL;
- living within a half mile of the community site location; and
- reporting to be likely or somewhat likely to shop at the market in response to: "how likely would you be to shop regularly at the Twin Cities Mobile Market if it came to your neighborhood each week (response options: likely to unlikely).
- willing and able to participate in all study data collection activities
Who cannot join
- planning to move in the next 12 months
- currently shopping at the mobile market
- not having a phone number or mailing address
- presence of a condition or abnormality that would prohibit participation in the study or the quality of the data
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Evaluating Diet, Food Insecurity, and Food Purchasing Outcomes of a Full-Service Mobile Food Market With a Cluster Randomized Trial
Mobile food markets have been proposed as a strategy for mitigating health disparities related to poor nutrition and diet/weight-related health conditions because they bring low-cost, healthy food directly to underserved populations. Full-service mobile markets may improve multiple aspects of the diet by providing foods to meet all dietary needs through a convenient one-stop shop. The full-service mobile market to be tested (Twin Cities Mobile Market) sells nutritious and staple foods from a bus that regularly visits low-income neighborhoods. Foods are sold at prices ~10% below those of grocery stores. SNAP/EBT is accepted, and a state-funded fruit/vegetable incentive program (Market Bucks) is available to shoppers. Working in partnership with our community team members, we will enroll 12 total sites and recruit 22 participants per site (N=264). We will collect baseline data and randomize sites to either receive the full-service mobile market intervention or serve as the waitlist control. We will then implement the full-service mobile market at intervention sites, follow participants for 6 months, and collect follow-up data. After follow-up data collection, waitlist control sites will receive the full-service mobile market intervention. Diet quality will be assessed through dietary recall interviews, food insecurity will be assessed by survey, and fruit and vegetable purchases will be measured by collecting one month of food purchase tracking forms at baseline and follow-up data collection. Analyses will determine whether the full-service mobile market changes diet quality, food security, and food purchasing outcomes.
- Conditions
- Healthy Diet, Nutrition, Healthy
- Being tested
- Full-service market intervention, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-service market interventionBehavioural
Full-service mobile market implementation: the market will visit intervention sites weekly. The market will carry items from all food groups including fresh, frozen and canned fruits and vegetables, whole grains, dairy/ dairy substitutes, proteins (e.g., frozen meat/fish, beans, eggs), and dry goods (e.g., cooking oil, spices). Prices on the market are affordable, approximately 10% lower than grocery stores.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control | Sham comparator | Participants in low-income neighborhoods and/or adjacent to low-income housing randomized to the control group will be placed on a waitlist to receive market service after follow- up data collection is complete. Receives: Other: No intervention |
| Experimental group | Experimental | Participants in low-income neighborhoods and/or adjacent to low-income housing randomized to the intervention group will receive the full-service market intervention following randomization. Receives: Behavioral: Full-service market intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet quality
Trained research staff certified in collecting dietary recalls using Nutrition Data System for Research software will collect three 24-hour dietary recall interviews (2 weekdays, 1 weekend day) from each participant at each measurement period. Dietary recall data will be used to calculate the Health Eating Index Total Score.
Measured: At baseline and 6 month follow-up
Secondary outcomes (7)
Food insecurity
Food security in the past 6 months will be measured with the 18-item Household food security screening module of the USDA. From this measure, household food security status (food insecure or food secure) will be calculated per USDA guidelines for each time Food insecurity (yes, no) will be measured with the 18-item food security screening module of the USDA.
Measured: At baseline and 6 month follow-up
Level of food insecurity
Food insecurity in the past 6 months will be measured with the 18-item food security screening module of the USDA. From this measure, household food security level (very low, low, marginal, and high food security) will be calculated per USDA guidelines for each time point, which will allow for calculation of level of food security prevalence at each time point.
Measured: At baseline and 6 month follow-up
Average weekly servings of fruits and vegetables procured
Participants will use forms to record the fruits and vegetables they procured for their household and mail the forms to the researchers in prepaid addressed envelopes. Form data will be entered into Nutrition Data System for Research software to measure average weekly servings of fruits and vegetables procured.
Measured: At baseline and 6 month follow-up
Fruit and vegetables (servings/day)
Trained research staff certified in collecting dietary recalls using Nutrition Data System for Research software will collect three 24-hour dietary recall interviews (2 weekdays, 1 weekend day) from each participant at each measurement period. Dietary recall data will be used to calculate the fruit and vegetables (servings/day) at baseline and follow-up.
Measured: At baseline and 6 month follow-up
Daily intake of energy (kcal/day)
Trained research staff certified in collecting dietary recalls using Nutrition Data System for Research software will collect three 24-hour dietary recall interviews (2 weekdays, 1 weekend day) from each participant at each measurement period. Dietary recall data will be used to calculate the daily intake of energy (kcal/day).
Measured: At baseline and 6 month follow-up
Percent calories from added sugar
Trained research staff certified in collecting dietary recalls using Nutrition Data System for Research software will collect three 24-hour dietary recall interviews (2 weekdays, 1 weekend day) from each participant at each measurement period. Dietary recall data will be used to calculate percent calories from added sugar.
Measured: At baseline and 6 month follow-up
Sodium (mg/day)
Trained research staff certified in collecting dietary recalls using Nutrition Data System for Research software will collect three 24-hour dietary recall interviews (2 weekdays, 1 weekend day) from each participant at each measurement period. Dietary recall data will be used to calculate sodium (mg/day) intake.
Measured: At baseline and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start12 Jan 2023
- Primary completion9 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Horning, PhD, RN, PHN, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672186
- Sponsor's protocol ID
- social pro
- Status last verified
- Oct 2025
- First submitted
- 12 Dec 2022
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, statistical analysis plan, and consent form are available on the trial's clinicaltrials.gov registry (NCT05672186). Quarto (R Markdown) documents will describe and implement all data extraction, cleaning, and analysis steps, and the resulting files will be made publicly available alongside all publications resulting from this study. To support the reproducibility and replication of our findings, upon completion of the trial, we will share anonymized quantitative participant data used in publications of outcomes with the community partner and researchers. Proposals to access the data should be directed to horn0199@umn.edu.
Publications
Horning ML, Gorman KS, Wagner S, Fulkerson JA, Wolfson J, Laska MN, Harnack L. Evaluating the impact of a full-service mobile food market on food security, diet quality and food purchases: a cluster randomised trial protocol and design paper. BMJ Open. 2025 Mar 6;15(3):e099414. doi: 10.1136/bmjopen-2025-099414.
PubMed 40050056
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Diet, Food Insecurity, and Food Purchasing Outcomes of a Full-Service Mobile Food Market With a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05672186
- Acronym / sponsor ID
- social pro
- Conditions
- Healthy Diet, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mobile food markets have been proposed as a strategy for mitigating health disparities related to poor nutrition and diet/weight-related health conditions because they bring low-cost, healthy food directly to underserved populations. Full-service mobile markets may improve multiple aspects of the diet by providing foods to meet all dietary needs through a convenient one-stop shop. The full-service mobile market to be tested (Twin Cities Mobile Market) sells nutritious and staple foods from a bus that regularly visits low-income neighborhoods. Foods are sold at prices ~10% below those of grocery stores. SNAP/EBT is accepted, and a state-funded fruit/vegetable incentive program (Market Bucks) is available to shoppers. Working in partnership with our community team members, we will enroll 12 total sites and recruit 22 participants per site (N=264). We will collect baseline data and randomize sites to either receive the full-service mobile market intervention or serve as the waitlist control. We will then implement the full-service mobile market at intervention sites, follow participants for 6 months, and collect follow-up data. After follow-up data collection, waitlist control sites will receive the full-service mobile market intervention. Diet quality will be assessed through dietary recall interviews, food insecurity will be assessed by survey, and fruit and vegetable purchases will be measured by collecting one month of food purchase tracking forms at baseline and follow-up data collection. Analyses will determine whether the full-service mobile market changes diet quality, food security, and food purchasing outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist control | Sham comparator | Other: No interventionParticipants in low-income neighborhoods and/or adjacent to low-income housing randomized to the control group will be placed on a waitlist to receive market service after follow- up data collection is complete. |
| Experimental group | Experimental | Behavioral: Full-service market interventionParticipants in low-income neighborhoods and/or adjacent to low-income housing randomized to the intervention group will receive the full-service market intervention following randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Community sites (e.g., public housing hi-rise, low-income senior living residence) must meet the following criteria:
- locale for low-income populations that experience difficulty in accessing healthy, affordable foods (e.g., public housing residences; low-income senior housing) or a community center in a low-income, low-food access (0.5 mile) census tract;
- willingness to be randomized to the intervention or waitlist control;
- located over 0.5 miles apart from other trial sites;
- willingness to allow for recruitment and data collection to occur in onsite community rooms
Key exclusion criteria (4 listed)
- planning to move in the next 12 months
- currently shopping at the mobile market
- not having a phone number or mailing address
- presence of a condition or abnormality that would prohibit participation in the study or the quality of the data
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 |
|---|---|---|
| Full-service market interventionFull-service mobile market implementation: the market will visit intervention sites weekly. The market will carry items from all food groups including fresh, frozen and canned fruits and vegetables, whole grains, dairy/ dairy substitutes, proteins (e.g., frozen meat/fish, beans, eggs), and dry goods (e.g., cooking oil, spices). Prices on the market are affordable, approximately 10% lower than grocery stores. | Behavioural | Experimental group |
| No interventionNo intervention | Other | Waitlist control |
Primary outcome
Diet quality
Time frame: At baseline and 6 month follow-up
Trained research staff certified in collecting dietary recalls using Nutrition Data System for Research software will collect three 24-hour dietary recall interviews (2 weekdays, 1 weekend day) from each participant at each measurement period. Dietary recall data will be used to calculate the Health Eating Index Total Score.
7 secondary outcomes
Food insecurity
Time frame: At baseline and 6 month follow-up
Level of food insecurity
Time frame: At baseline and 6 month follow-up
Average weekly servings of fruits and vegetables procured
Time frame: At baseline and 6 month follow-up
Fruit and vegetables (servings/day)
Time frame: At baseline and 6 month follow-up
Daily intake of energy (kcal/day)
Time frame: At baseline and 6 month follow-up
Percent calories from added sugar
Time frame: At baseline and 6 month follow-up
Sodium (mg/day)
Time frame: At baseline and 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Derived from this study: PubMed 40050056Horning ML, Gorman KS, Wagner S, Fulkerson JA, Wolfson J, Laska MN, Harnack L. Evaluating the impact of a full-service mobile food market on food security, diet quality and food purchases: a cluster randomised trial protocol and design paper. BMJ Open. 2025 Mar 6;15(3):e099414. doi: 10.1136/bmjopen-2025-099414.
- Individual participant dataSharing planned: Yes. The study protocol, statistical analysis plan, and consent form are available on the trial's clinicaltrials.gov registry (NCT05672186). Quarto (R Markdown) documents will describe and implement all data extraction, cleaning, and analysis steps, and the resulting files will be made publicly available alongside all publications resulting from this study. To support the reproducibility and replication of our findings, upon completion of the trial, we will share anonymized quantitative participant data used in publications of outcomes with the community partner and researchers. Proposals to access the data should be directed to horn0199@umn.edu.
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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.
Melissa Horning, PhD, RN, PHN principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-service market intervention in people with Healthy Diet and Nutrition, Healthy, run by University of Minnesota 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 12 inclusion and 4 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 31 Oct 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diet quality (time frame: At baseline and 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05672186, which also lists 1 linked publication.
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 31 Oct 2025.