Good Bowls: Eat Well At Work

NCT05776303 | Active Not Recruiting

• 1 other identifier: 22-2412
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nutrition, Healthy; Behavior, Eating

Keywords

Med-South Diet; Worksite Intervention; Subsidized Food; App-based Messaging

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in weight

  Up to 8 months

• Change in blood pressure

  Up to 8 months

• Change in skin carotenoids

  Up to 8 months

• Change in food security

  Up to 8 months

Study Arms (2)

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.

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.

Behavioral: Good Bowls; Behavioral: Good Bowls + App Nudges

Interventions

Good Bowls BEHAVIORAL

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

Good Bowls + App Nudges, followed by Good Bowls alone; Good Bowls, followed by Good Bowls + App Nudges

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.

Good Bowls + App Nudges, followed by Good Bowls alone; Good Bowls, followed by Good Bowls + App Nudges

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Equiti Food, LLC: lead
• National Institutes of Health (NIH): collaborator
• University of North Carolina, Chapel Hill: collaborator
• University of North Carolina, Greensboro: collaborator
• North Carolina State University: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Kurt Ribisl, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: March 15, 2023
• Primary Completion: July 21, 2025
• Study Completion: July 31, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 9 to 36 months following publication
• Access Criteria: Investigator with IRB, IEC, or REB approval and an executed data use agreement with UNC and Equiti Foods, LLC

Locations

US (1)