Clinical trial NCT05776303: Good Bowls: Eat Well At Work
Official title: Phase II (Intervention): Good Bowls: Empowering Communities to Achieve Good Food Access and Health Equity
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Nutrition, Healthy
Behavior, Eating
Keywords: Med-South Diet
Worksite Intervention
Subsidized Food
App-based Messaging
Lead sponsor: Equiti Food, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: University of North Carolina, Chapel Hill
name: University of North Carolina, Greensboro
name: North Carolina State University
First posted: 2023-03-20
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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, 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in nutrition as measured by the Mediterranean Diet 14-Item Screener Score
timeFrame: Baseline, 4 months
measure: Change in nutrition as measured by the Mediterranean Diet 14-Item Screener Score
timeFrame: 4 months, 8 months
measure: Change in nutrition as measured by the Mediterranean Diet 14-Item Screener Score
timeFrame: Baseline, 8 months
Secondary outcomes:
measure: Change in weight
timeFrame: Up to 8 months
measure: Change in blood pressure
timeFrame: Up to 8 months
measure: Change in skin carotenoids
timeFrame: Up to 8 months
measure: Change in food security
timeFrame: Up to 8 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kurt Ribisl, PhD
role: PRINCIPAL_INVESTIGATOR
References: