NCT05672186

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

January 12, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2025

Completed
Last Updated

October 31, 2025

Status Verified

October 1, 2025

Enrollment Period

2.7 years

First QC Date

December 12, 2022

Last Update Submit

October 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline and 6 month follow-up

Secondary Outcomes (7)

  • Food insecurity

    At baseline and 6 month follow-up

  • Level of food insecurity

    At baseline and 6 month follow-up

  • Average weekly servings of fruits and vegetables procured

    At baseline and 6 month follow-up

  • Fruit and vegetables (servings/day)

    At baseline and 6 month follow-up

  • Daily intake of energy (kcal/day)

    At baseline and 6 month follow-up

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Full-service market intervention

Interventions

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.

Experimental group

No intervention

Waitlist control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Melissa Horning, PhD, RN, PHN

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Following site enrollment, sites will be randomized by wave to receive the full-service market intervention or serve as a waitlist control by the study statistician, who will be blinded to study site names. After randomization, the study statistician will be unblinded to site names by being given the key that matches sites with their assigned numbers. The study statistician will use this key to inform the mobile market co-investigator of site allocation to allow time for the mobile market to plan for market routes and schedules while baseline data collection is ongoing. Participants, site locations, the PI, university non-statistician trial investigators, and research staff will be blinded to site randomization results until baseline data collection is complete. Only the project manager and study statistician will be aware of the key (the link between the site names and the assigned site numbers linked to the data to be used in analysis) until analysis is complete.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2022

First Posted

January 5, 2023

Study Start

January 12, 2023

Primary Completion

October 9, 2025

Study Completion

October 24, 2025

Last Updated

October 31, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Upon completion of the trial
Access Criteria
Proposals to access the data should be directed to horn0199@umn.edu.

Locations