EWAW: Good Bowls: Eat Well At Work

Sponsor
Equiti Food, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05776303
Collaborator
National Institutes of Health (NIH) (NIH), University of North Carolina, Chapel Hill (Other), University of North Carolina, Greensboro (Other), North Carolina State University (Other)
240
1
2
26.5
9

Study Details

Study Description

Brief Summary

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, our 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Good Bowls
  • Behavioral: Good Bowls + App Nudges
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II (Intervention): Good Bowls: Empowering Communities to Achieve Good Food Access and Health Equity
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
May 31, 2025
Anticipated Study Completion Date :
May 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in nutrition as measured by the Mediterranean Diet 14-Item Screener Score [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 [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 [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 Outcome Measures

  1. Change in weight [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599

Sponsors and Collaborators

  • Equiti Food, LLC
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Equiti Food, LLC
ClinicalTrials.gov Identifier:
NCT05776303
Other Study ID Numbers:
  • 22-2412
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 20, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Equiti Food, LLC

Study Results

No Results Posted as of Mar 20, 2023