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OpenTrials
Completed

NCT Number: NCT05776303

Good Bowls: Eat Well At Work

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Good Bowls

Behavioral

Healthy, frozen subsidized meals are made conveniently available on worksites.

Good Bowls + App Nudges

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean Change in Weight

    Time frame: From enrollment to the end of the study at 8 months

    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.

  2. Mean Change in Blood Pressure

    Time frame: From enrollment to the end of the study at 8 months

    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.

  3. Mean Change in Skin Carotenoid Levels

    Time frame: From enrollment to the end of the study at 8 months

    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.

  4. Change in Food Security

    Time frame: From enrollment to the end of the study at 8 months

    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.

Sponsors and collaborators

Lead sponsor

Equiti Food, LLC

Industry

Collaborators

  • National Institutes of Health (NIH)
  • North Carolina State University
  • University of North Carolina, Chapel Hill
  • University of North Carolina, Greensboro

Registry information

Official study title

Phase II (Intervention): Good Bowls: Empowering Communities to Achieve Good Food Access and Health Equity

Acronym: EWAW

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2023
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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