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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
201
Healthy, frozen subsidized meals are made conveniently available on worksites.
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.
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Mean Change in Nutrition as Measured by the Mediterranean Diet 14-Item Screener Score
A slightly adapted 14-item Mediterranean diet screener was used to assess adherence to a Mediterranean-style dietary pattern. Each item was scored 0 or 1, producing a total score ranging from 0 to 14, with higher scores indicating greater adherence. The outcome, mean change in score from the beginning of exposure to the treatment to the end of the exposure to the treatment, was calculated by first subtracting each participant's score at the start of exposure from their score at the end of exposure, and then by averaging the individual changes across all participants.
Time frame: From enrollment to the end of the study at 8 months
Mean Change in Weight
Weight measured using a SECA 874dr scale. The outcome, mean change in weight from the beginning of exposure to the treatment to the end of the exposure to the treatment, was calculated by first subtracting each participant's weight at the start of exposure from their weight at the end of exposure, and then by averaging the individual changes across all participants.
Time frame: From enrollment to the end of the study at 8 months
Mean Change in Blood Pressure
Systolic and diastolic blood pressure was measured using an automated portable sphygmomanometer (Omron HEM-907XL, Vernon Hills, IL). Two readings were taken with a 1-minute interval and averaged by the device. The outcome, mean change in systolic and diastolic blood pressure from the beginning of exposure to the treatment to the end of the exposure to the treatment, was calculated by first subtracting each participant's blood pressure at the start of exposure from their blood pressure at the end of exposure, and then by averaging the individual changes across all participants.
Time frame: From enrollment to the end of the study at 8 months
Mean Change in Skin Carotenoid Levels
Skin carotenoid levels were measured using pressure-mediated spectroscopy (Veggie Meter®). Three readings were taken and averaged. Scores range from 0-800 arbitrary units with higher values indicating greater carotenoid concentrations or greater fruit and vegetable intake. The outcome, mean change in skin carotenoid level from the beginning of exposure to the treatment to the end of the exposure to the treatment, was calculated by first subtracting each participant's skin carotenoid level at the start of exposure from their skin carotenoid level at the end of exposure, and then by averaging the individual changes across all participants.
Time frame: From enrollment to the end of the study at 8 months
Change in Food Security
Food security status was assessed using the validated two-item Hunger Vital Sign™ screener for the past 12 months: (1) "We worried whether our food would run out before we got money to buy more" and (2) "The food we bought just didn't last and we didn't have money to get more." Response options: Often true, Sometimes true, Never true, Don't know. Participants who selected "Often true" or "Sometimes true" for either item were categorized as "At Risk for Food Insecurity." Participants who did not select "Often true" or "Sometimes true" for either item were categorized as "Food Secure." The outcome, change in food security status from the beginning of exposure to the treatment to the end of the exposure to the treatment was tabulated by counting the number of participants that changed food security status or remained the same during the exposure to the treatment.
Time frame: From enrollment to the end of the study at 8 months
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