Good Bowls: Eat Well At Work (EWAW)

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:

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 Overview

• Status: Completed
• Conditions: Nutrition, Healthy; Behavior, Eating
• Intervention / Treatment: Behavioral: Good Bowls; Behavioral: Good Bowls + App Nudges

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Good Bowls + App Nudges, followed by Good Bowls alone; 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.	Behavioral: Good Bowls; Healthy, frozen subsidized meals are made conveniently available on worksites.; Behavioral: Good Bowls + App Nudges; 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.
Active Comparator: Good Bowls, followed by Good Bowls + App Nudges; 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.	Behavioral: Good Bowls; Healthy, frozen subsidized meals are made conveniently available on worksites.; Behavioral: Good Bowls + App Nudges; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of the study at 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	From enrollment to the end of the study at 8 months

Collaborators and Investigators

• Sponsor: Equiti Food, LLC
• Collaborators: National Institutes of Health (NIH); University of North Carolina, Chapel Hill; University of North Carolina, Greensboro; North Carolina State University
• Investigators: Principal Investigator: Alice Ammerman, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): July 21, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Worksite Intervention; Med-South Diet; Subsidized Food; App-based Messaging
• Additional Relevant MeSH Terms: Behavior; Behavior, Animal; Feeding Behavior
• Other Study ID Numbers: 22-2412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: Investigator with IRB, IEC, or REB approval and an executed data use agreement with UNC and Equiti Foods, LLC
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No