Behavior, Eating, Nutrition, Healthy
Conditions
Keywords
Med-South Diet, Worksite Intervention, Subsidized Food, App-based Messaging
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.
Interventions
BEHAVIORALGood Bowls
Healthy, frozen subsidized meals are made conveniently available on worksites.
BEHAVIORALGood 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.
Sponsors
Equiti Food, LLC
National Institutes of Health (NIH)
University of North Carolina, Chapel Hill
University of North Carolina, Greensboro
North Carolina State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Nutrition as Measured by the Mediterranean Diet 14-Item Screener Score | From enrollment to the end of the study at 8 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Weight | From enrollment to the end of the study at 8 months | 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. |
| Mean Change in Blood Pressure | From enrollment to the end of the study at 8 months | 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. |
| Mean Change in Skin Carotenoid Levels | From enrollment to the end of the study at 8 months | 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. |
| Change in Food Security | From enrollment to the end of the study at 8 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlice Ammerman, PhD
University of North Carolina, Chapel Hill
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age group 18-29 years | 14 Participants |
| Age, Customized Age group 30-44 years | 66 Participants |
| Age, Customized Age group 45-64 years | 96 Participants |
| Age, Customized Age group 65 years and older | 8 Participants |
| Blood Pressure Diastolic | 79.51 mmHg STANDARD_DEVIATION 11.35 |
| Blood Pressure Systolic | 120.22 mmHg STANDARD_DEVIATION 16.52 |
| Education Bachelor's degree or higher | 17 Participants |
| Education High school or GED | 12 Participants |
| Education Less than high school | 10 Participants |
| Education Some college | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Food Security At Risk for Food Insecurity | 15 Participants |
| Food Security Food Secure | 41 Participants |
| Income $100,000 to $149,999 | 8 Participants |
| Income $150,000 to $199,999 | 6 Participants |
| Income <$20,000 | 7 Participants |
| Income $200,000 or more | 2 Participants |
| Income $20,000 to $34,999 | 2 Participants |
| Income $35,000 to $49,999 | 19 Participants |
| Income $50,000 to $74,999 | 33 Participants |
| Income $75,000 to $99,999 | 11 Participants |
| Mediterranean Diet Score | 5.79 Mediterranean Diet Score (range 0-14) STANDARD_DEVIATION 2.35 |
| Race/Ethnicity, Customized Race Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race American Indian | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Black | 56 Participants |
| Race/Ethnicity, Customized Race Don't know | 0 Participants |
| Race/Ethnicity, Customized Race More than one race | 7 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian | 0 Participants |
| Race/Ethnicity, Customized Race Other | 11 Participants |
| Race/Ethnicity, Customized Race Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race White | 25 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 89 Participants |
| Skin Carotenoid Levels | 243.81 Carotenoid level (arbitrary units) STANDARD_DEVIATION 75.04 |
| Weight | 197.82 Pounds STANDARD_DEVIATION 52.39 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 77 | 0 / 95 |
| other Total, other adverse events | 0 / 81 | 0 / 77 | 0 / 95 |
| serious Total, serious adverse events | 0 / 81 | 0 / 77 | 0 / 95 |
Outcome results
None listed