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 blue-collar workers 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: Blue-collar workers in rural manufacturing plants.

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: Enrolling by invitation
• Conditions: Nutrition, Healthy; Behavior, Eating
• Intervention / Treatment: Behavioral: Good Bowls; Behavioral: Good Bowls + App Nudges

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gena Gerstner, PhD; Phone Number: 919-843-2014; Email: gerstner@email.unc.edu
• Study Contact Backup: Name: Alice Ammerman, PhD; Phone Number: 919-966-6082; Email: alice_ammerman@unc.edu

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 blue-collar 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
Change in nutrition as measured by the Mediterranean Diet 14-Item Screener Score	A slightly adapted version of the Mediterranean Diet 14-item validated screener will be used for nutritional assessment. The score ranges from 0-14, with a higher score indicating higher adherence to the Mediterranean Diet.	Baseline, 4 months
Change in nutrition as measured by the Mediterranean Diet 14-Item Screener Score	A slightly adapted version of the Mediterranean Diet 14-item validated screener will be used for nutritional assessment. The score ranges from 0-14, with a higher score indicating higher adherence to the Mediterranean Diet.	4 months, 8 months
Change in nutrition as measured by the Mediterranean Diet 14-Item Screener Score	A slightly adapted version of the Mediterranean Diet 14-item validated screener will be used for nutritional assessment. The score ranges from 0-14, with a higher score indicating higher adherence to the Mediterranean Diet.	Baseline, 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight	Weight in pounds as measured by electronic scale as the average of two measures. SECA 874dr scales will be used and assessed with standardized weights monthly for accuracy. Assessed at baseline (i.e., pre-intervention), 4 months (i.e., before crossover), 8 months (i.e., post-intervention).	Up to 8 months
Change in blood pressure	Blood pressure (systolic and diastolic in mmHg) as measured by non-invasive automated monitor (Omron HEM-907XL, Vernon Hills, IL) with a first measure after seated for 5 minutes and 2 repeat measures at 1-minute intervals. Assessed at baseline (i.e., pre-intervention), 4 months (i.e., before crossover), 8 months (i.e., post-intervention).	Up to 8 months
Change in skin carotenoids	Skin carotenoids as measured by a Reflection Spectroscopy Device ("Veggie Meter"™) placed on the participant's finger for a simple scan for three separate trials. Scores range from 0-800 arbitrary units with higher estimated value indicating greater carotenoid concentrations. Assessed at baseline (i.e., pre-intervention), 4 months (i.e., before crossover), 8 months (i.e., post-intervention).	Up to 8 months
Change in food security	Food security as measured by the 2-Item Food Security Screening Tool. The two item response categories are: "Often True," "Sometimes True," "Never True" or "Don't Know" for the past 12 months. Often true and sometimes true are categorized as food insecure.	Up to 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: Kurt Ribisl, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 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 (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Worksite Intervention; Med-South Diet; Subsidized Food; App-based Messaging
• 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 ofNorth 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