Nutrition, Healthy Clinical Trial
— EWAWOfficial title:
Phase II (Intervention): Good Bowls: Empowering Communities to Achieve Good Food Access and Health Equity
| Verified date | June 2023 |
| Source | Equiti Food, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 240 |
| Est. completion date | May 31, 2025 |
| Est. primary completion date | May 31, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Equiti Food, LLC | National Institutes of Health (NIH), North Carolina State University, University of North Carolina, Chapel Hill, University of North Carolina, Greensboro |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Change in weight | 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). |
Up to 8 months | |
| Secondary | Change in blood pressure | 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). |
Up to 8 months | |
| Secondary | Change in skin carotenoids | 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). |
Up to 8 months | |
| Secondary | Change in food security | 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. | Up to 8 months |