Healthy Meal Program + Tech Nudges for Healthy Nutrition

(EWAW Trial)

Overseen By Alice Ammerman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Equiti Food, LLC

Disqualifiers: Severe food allergies, Advanced kidney disease, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Good Bowls, Good Bowls + App Nudges?

Research shows that using nudges, like signs or changing food placement, can encourage people to make healthier food choices, such as drinking more water or choosing healthier desserts. This suggests that similar strategies could help make the Good Bowls program more effective in promoting healthy eating. ^{1 2 3 4 5}

Is the Healthy Meal Program + Tech Nudges for Healthy Nutrition safe for humans?

The research articles reviewed do not provide specific safety data for the Healthy Meal Program + Tech Nudges or its variations like Good Bowls. However, nudging strategies generally focus on encouraging healthier food choices and are not associated with safety risks. ^{1 2 4 6 7}

How does the Healthy Meal Program + Tech Nudges treatment differ from other treatments for healthy nutrition?

This treatment is unique because it combines healthy meal options with technology-based nudges (reminders or prompts) to encourage healthier eating habits. Unlike traditional dietary interventions, it uses an app to provide personalized nudges, making it more interactive and potentially more engaging for participants. ^{6 8 9 10 11}

What is the purpose of this trial?

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.

Research Team

Kurt Ribisl, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for blue-collar workers at rural manufacturing plants who can consent to participate, control their diet, and commit to the study for a year. It's not suitable for those with advanced kidney disease, severe psychiatric conditions or food allergies, cognitive impairments, or disabilities that hinder full participation.

Inclusion Criteria

Willing and able to provide written informed consent and participate in all study activities

No plans to move from the area for at least 1 year

Free living to the extent that participant has control over dietary intake

Exclusion Criteria

I am able to fully participate in study activities without assistance.

Severe food allergies

Known psychosis or major psychiatric illness that prevents participation with study activities

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants are randomized to either Good Bowls alone or Good Bowls + Phone App nudges for four months

16 weeks

Monthly visits for weight and blood pressure measurements

Crossover Treatment

Participants switch groups to receive the alternate intervention for another four months

16 weeks

Monthly visits for weight and blood pressure measurements

Follow-up

Participants are monitored for changes in diet adherence, weight, blood pressure, and food security

4 weeks

Treatment Details

Interventions

• Good Bowls
• Good Bowls + App Nudges

Trial Overview The study tests if providing 'Good Bowls' healthy meals alone or combined with mobile app nudges improves diet quality (measured by a Mediterranean diet screener), weight, blood pressure, carotenoid levels and food security among participants over an eight-month period using a crossover design.

Participant Groups

Group I: Good Bowls + App Nudges, followed by Good Bowls alone Experimental Treatment 2 Interventions

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.

Group II: Good Bowls, followed by Good Bowls + App Nudges Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Equiti Food, LLC

Lead Sponsor

Trials

1

Recruited

240+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of North Carolina, Greensboro

Collaborator

Trials

33

Recruited

16,700+

North Carolina State University

Collaborator

Trials

38

Recruited

50,000+

Findings from Research

In a study involving 88 early childhood education centers, incorporating nudge strategies into workshop invitations did not significantly increase registration rates compared to generic invitations, with only 25% of the intervention group registering versus 20% in the control group.

The study found no significant differences in invitation recall or acceptability between the two groups, suggesting that low-intensity behavioral nudges may not be effective in promoting participation in nutrition education workshops.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Nudge Strategies on Nutrition Education Participation in Child Care: Randomized Controlled Trial. Grady, A., Barnes, C., Lum, M., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Nudging food service users to choose fruit- and vegetable-rich items: Five field studies. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Nudging healthy eating in Dutch sports canteens: a multi-method case study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Nudging healthy college dining hall choices using behavioral economics. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of Nudge Strategies on Nutrition Education Participation in Child Care: Randomized Controlled Trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Nudging strategies to improve food choices of healthcare workers in the workplace cafeteria: A pragmatic field study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Nudging healthy and sustainable food choices: three randomized controlled field experiments using a vegetarian lunch-default as a normative signal. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Nudging the obese: a UK-US consideration. [2016]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Implementation of a Multi-Component School Lunch Environmental Change Intervention to Improve Child Fruit and Vegetable Intake: A Mixed-Methods Study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Design of ChooseWell 365: Randomized controlled trial of an automated, personalized worksite intervention to promote healthy food choices and prevent weight gain. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Are You "Nudgeable"? Factors Affecting the Acceptance of Healthy Eating Nudges in a Cafeteria Setting. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Crumbs: Lightweight Daily Food Challenges to Promote Engagement and Mindfulness. [2020]