Nutrition, HealthyEWAWNCT05776303
Good Bowls: Eat Well At Work
A study testing Good Bowls and Good Bowls + App Nudges in people with Nutrition, Healthy and Behavior, Eating, run by Equiti Food, LLC at 1 site in United States.
Trial summary
The goal of this clinical trial is to improve the health of workers at their worksite by providing subsidized healthy meals supported by nutrition education and behavioral nudges using mobile health and Bluetooth technology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Behavior, Eating
- What is being tested?
- Good Bowls and Good Bowls + App Nudges
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 31 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employed at participating worksite
- No plans to move from the area for at least 1 year
- Free living to the extent that participant has control over dietary intake
- Willing and able to provide written informed consent and participate in all study activities
Who cannot join
- Severe food allergies
- Advanced kidney disease (estimated creatinine clearance < 30 ml/min)
- Known psychosis or major psychiatric illness that prevents participation with study activities
- Cognitive impairment, frailty, or other disability such that individual cannot fully participate in study activities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Phase II (Intervention): Good Bowls: Empowering Communities to Achieve Good Food Access and Health Equity
The goal of this clinical trial is to improve the health of workers at their worksite by providing subsidized healthy meals supported by nutrition education and behavioral nudges using mobile health and Bluetooth technology.
The aim of this study is to:
Read more
Randomize 240 individuals in 8-10 worksites to either Good Bowls alone or Good Bowls + Phone App nudges. Using a crossover design, the primary outcome is the score on a validated Mediterranean diet screener, with secondary outcomes including weight, blood pressure, carotenoid levels, and food security.
Participants: Workers at blue and white-collar worksites.
Procedures: Workers will be recruited from 8-10 worksites who will be initially randomized within each site to Good Bowls alone or Good Bowls + Phone App nudges. Initial assignment will be followed for four months, after which the groups will crossover for the subsequent four months. The investigators will collect survey data as well as some physiologic measures including skin scanning (non-invasive), weight, and blood pressure. Effects between groups will be determined.
- Conditions
- Nutrition, Healthy, Behavior, Eating
- Being tested
- Good Bowls, Good Bowls + App Nudges
- Keywords
- Med-South Diet, Worksite Intervention, Subsidized Food, App-based Messaging
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Good BowlsBehavioural
Healthy, frozen subsidized meals are made conveniently available on worksites.
Good Bowls + App NudgesBehavioural
Healthy, frozen subsidized meals are made conveniently available on worksites.
Additionally, Bluetooth enabled beacons will be set up at each worksite that will send location specific messages to an individual's Smartphone via an App. These messages will include nutritional information, tips, and behavioral nudges.
| Study group | Role | What they receive |
|---|---|---|
| Good Bowls + App Nudges, followed by Good Bowls alone | Experimental | Participants in this arm will be exposed to Good Bowls + App Nudges throughout the first four months followed by four months of Good Bowls alone. Receives: Behavioral: Good Bowls; Behavioral: Good Bowls + App Nudges |
| Good Bowls, followed by Good Bowls + App Nudges | Active comparator | Participants in this arm will be exposed to Good Bowls alone throughout the first four months followed by four months of Good Bowls + App Nudges. Receives: Behavioral: Good Bowls; Behavioral: Good Bowls + App Nudges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Nutrition as Measured by the Mediterranean Diet 14-Item Screener Score
A slightly adapted 14-item Mediterranean diet screener was used to assess adherence to a Mediterranean-style dietary pattern. Each item was scored 0 or 1, producing a total score ranging from 0 to 14, with higher scores indicating greater adherence. The outcome, mean change in score from the beginning of exposure to the treatment to the end of the exposure to the treatment, was calculated by first subtracting each participant's score at the start of exposure from their score at the end of exposure, and then by averaging the individual changes across all participants.
Measured: From enrollment to the end of the study at 8 months
Secondary outcomes (4)
Mean Change in Weight
Weight measured using a SECA 874dr scale. The outcome, mean change in weight from the beginning of exposure to the treatment to the end of the exposure to the treatment, was calculated by first subtracting each participant's weight at the start of exposure from their weight at the end of exposure, and then by averaging the individual changes across all participants.
Measured: From enrollment to the end of the study at 8 months
Mean Change in Blood Pressure
Systolic and diastolic blood pressure was measured using an automated portable sphygmomanometer (Omron HEM-907XL, Vernon Hills, IL). Two readings were taken with a 1-minute interval and averaged by the device. The outcome, mean change in systolic and diastolic blood pressure from the beginning of exposure to the treatment to the end of the exposure to the treatment, was calculated by first subtracting each participant's blood pressure at the start of exposure from their blood pressure at the end of exposure, and then by averaging the individual changes across all participants.
Measured: From enrollment to the end of the study at 8 months
Mean Change in Skin Carotenoid Levels
Skin carotenoid levels were measured using pressure-mediated spectroscopy (Veggie Meter®). Three readings were taken and averaged. Scores range from 0-800 arbitrary units with higher values indicating greater carotenoid concentrations or greater fruit and vegetable intake. The outcome, mean change in skin carotenoid level from the beginning of exposure to the treatment to the end of the exposure to the treatment, was calculated by first subtracting each participant's skin carotenoid level at the start of exposure from their skin carotenoid level at the end of exposure, and then by averaging the individual changes across all participants.
Measured: From enrollment to the end of the study at 8 months
Change in Food Security
Food security status was assessed using the validated two-item Hunger Vital Sign™ screener for the past 12 months: (1) "We worried whether our food would run out before we got money to buy more" and (2) "The food we bought just didn't last and we didn't have money to get more." Response options: Often true, Sometimes true, Never true, Don't know. Participants who selected "Often true" or "Sometimes true" for either item were categorized as "At Risk for Food Insecurity." Participants who did not select "Often true" or "Sometimes true" for either item were categorized as "Food Secure." The outcome, change in food security status from the beginning of exposure to the treatment to the end of the exposure to the treatment was tabulated by counting the number of participants that changed food security status or remained the same during the exposure to the treatment.
Measured: From enrollment to the end of the study at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start15 Mar 2023
- Primary completion21 Jul 2025
- Study completion31 Jul 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 Nutrition, HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomize 240 individuals in 8-10 worksites to either Good Bowls alone or Good Bowls + Phone App nudges at a 1:1 allocation ratio. Initial assignment will be followed for four months, after which the groups will crossover for the subsequent four months.
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Equiti Food, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), University of North Carolina, Chapel Hill, University of North Carolina, Greensboro, North Carolina State University
- Responsible party
- Sponsor
- Investigators
- Alice Ammerman, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776303
- Sponsor's protocol ID
- 22-2412
- Acronym
- EWAW
- Status last verified
- Aug 2026
- First submitted
- 8 Mar 2023
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC) and Equiti Foods, LLC.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II (Intervention): Good Bowls: Empowering Communities to Achieve Good Food Access and Health Equity
- ClinicalTrials.gov ID
- NCT05776303
- Acronym / sponsor ID
- EWAW / 22-2412
- Conditions
- Nutrition, Healthy, Behavior, Eating
- Keywords
- Med-South Diet, Worksite Intervention, Subsidized Food, App-based Messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Equiti Food, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), University of North Carolina, Chapel Hill, University of North Carolina, Greensboro, North Carolina State University
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Posted 28 Aug 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 clinical trial is to improve the health of workers at their worksite by providing subsidized healthy meals supported by nutrition education and behavioral nudges using mobile health and Bluetooth technology.
The aim of this study is to:
Randomize 240 individuals in 8-10 worksites to either Good Bowls alone or Good Bowls + Phone App nudges. Using a crossover design, the primary outcome is the score on a validated Mediterranean diet screener, with secondary outcomes including weight, blood pressure, carotenoid levels, and food security.
Participants: Workers at blue and white-collar worksites.
Procedures: Workers will be recruited from 8-10 worksites who will be initially randomized within each site to Good Bowls alone or Good Bowls + Phone App nudges. Initial assignment will be followed for four months, after which the groups will crossover for the subsequent four months. The investigators will collect survey data as well as some physiologic measures including skin scanning (non-invasive), weight, and blood pressure. Effects between groups will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomize 240 individuals in 8-10 worksites to either Good Bowls alone or Good Bowls + Phone App nudges at a 1:1 allocation ratio. Initial assignment will be followed for four months, after which the groups will crossover for the subsequent four months.
| Arm | Type | Receives |
|---|---|---|
| Good Bowls + App Nudges, followed by Good Bowls alone | Experimental | Behavioral: Good Bowls, Behavioral: Good Bowls + App NudgesParticipants in this arm will be exposed to Good Bowls + App Nudges throughout the first four months followed by four months of Good Bowls alone. |
| Good Bowls, followed by Good Bowls + App Nudges | Active comparator | Behavioral: Good Bowls, Behavioral: Good Bowls + App NudgesParticipants in this arm will be exposed to Good Bowls alone throughout the first four months followed by four months of Good Bowls + App Nudges. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Employed at participating worksite
- No plans to move from the area for at least 1 year
- Free living to the extent that participant has control over dietary intake
- Willing and able to provide written informed consent and participate in all study activities
Key exclusion criteria (4 listed)
- Severe food allergies
- Advanced kidney disease (estimated creatinine clearance < 30 ml/min)
- Known psychosis or major psychiatric illness that prevents participation with study activities
- Cognitive impairment, frailty, or other disability such that individual cannot fully participate in study activities
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 |
|---|---|---|
| Good BowlsHealthy, frozen subsidized meals are made conveniently available on worksites. | Behavioural | Good Bowls + App Nudges, followed by Good Bowls alone, Good Bowls, followed by Good Bowls + App Nudges |
| Good Bowls + App NudgesHealthy, frozen subsidized meals are made conveniently available on worksites. Additionally, Bluetooth enabled beacons will be set up at each worksite that will send location specific messages to an individual's Smartphone via an App. These messages will include nutritional information, tips, and behavioral nudges. | Behavioural | Good Bowls + App Nudges, followed by Good Bowls alone, Good Bowls, followed by Good Bowls + App Nudges |
Primary outcome
Mean Change in Nutrition as Measured by the Mediterranean Diet 14-Item Screener Score
Time frame: From enrollment to the end of the study at 8 months
A slightly adapted 14-item Mediterranean diet screener was used to assess adherence to a Mediterranean-style dietary pattern. Each item was scored 0 or 1, producing a total score ranging from 0 to 14, with higher scores indicating greater adherence. The outcome, mean change in score from the beginning of exposure to the treatment to the end of the exposure to the treatment, was calculated by first subtracting each participant's score at the start of exposure from their score at the end of exposure, and then by averaging the individual changes across all participants.
4 secondary outcomes
Mean Change in Weight
Time frame: From enrollment to the end of the study at 8 months
Mean Change in Blood Pressure
Time frame: From enrollment to the end of the study at 8 months
Mean Change in Skin Carotenoid Levels
Time frame: From enrollment to the end of the study at 8 months
Change in Food Security
Time frame: From enrollment to the end of the study at 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC) and Equiti Foods, LLC.
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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.
Alice Ammerman, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Good Bowls and Good Bowls + App Nudges in people with Nutrition, Healthy and Behavior, Eating, run by Equiti Food, LLC 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 4 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 28 Aug 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 28 Aug 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?
Mean Change in Nutrition as Measured by the Mediterranean Diet 14-Item Screener Score (time frame: From enrollment to the end of the study at 8 months). 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 28 Aug 2026.