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Active, Not Recruiting

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Nutrition, Healthy Behavior Behavior, Animal Behavior, Eating Feeding Behavior

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. Change in nutrition as measured by the Mediterranean Diet 14-Item Screener Score

    Time frame: Baseline, 4 months

    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.

  2. Change in nutrition as measured by the Mediterranean Diet 14-Item Screener Score

    Time frame: 4 months, 8 months

    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.

  3. Change in nutrition as measured by the Mediterranean Diet 14-Item Screener Score

    Time frame: Baseline, 8 months

    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.

Secondary outcomes

  1. Change in weight

    Time frame: Up to 8 months

    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).

  2. Change in blood pressure

    Time frame: Up to 8 months

    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).

  3. Change in skin carotenoids

    Time frame: Up to 8 months

    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).

  4. Change in food security

    Time frame: Up to 8 months

    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.

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
Jul 18, 2025

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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