Customized Meal Plans for Healthy Eating

Overseen By Kelly Lopez, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Kaiser Permanente

Disqualifiers: Not in FoodRx study

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will develop and test and app that will create meal plans to improve diet quality and support weight loss. This app will allow participants to customize their meal plans and substitute recipes for nutritionally equivalent options that they find more appealing, thus potentially increasing adherence.

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the treatment FoodRx App?

Research shows that food prescription programs, like the FoodRx App, can help improve access to healthy foods and promote healthier eating habits, especially in communities with limited resources. For example, a study found that participants in a food prescription program increased their fruit and vegetable consumption and developed more positive attitudes toward healthy eating. ^{1 2 3 4 5}

Is the Customized Meal Plans for Healthy Eating app safe for use in humans?

The studies reviewed did not report any safety concerns related to the use of diet tracking and nutrition apps, suggesting they are generally safe for human use. ^{2 6 7 8 9}

How does the treatment of customized meal plans for healthy eating differ from other treatments for promoting healthy eating?

Customized meal plans for healthy eating are unique because they focus on tailoring dietary recommendations to individual preferences and needs, potentially using technology like mobile apps or computer programs to create personalized menus. This approach contrasts with standard dietary guidelines by offering a more personalized and flexible way to encourage healthy eating habits. ^{1 3 9 10 11}

Eligibility Criteria

This trial is for adults over 18 years old who are already part of the FoodRx study, have a BMI greater than 27, and want to lose weight. It's designed to help improve their eating habits.

Inclusion Criteria

I am over 18, have a BMI over 27, and want to lose weight. I'm also enrolled in the FoodRx study.

Exclusion Criteria

Not enrolled in Food Rx

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the FoodRx app to customize their weekly meal plans and receive grocery delivery

4 weeks

Follow-up

Participants are monitored for dietary quality and weight loss after using the app

4 weeks

Treatment Details

Interventions

• FOOD PRESCRIPTION APP

Trial Overview The trial is testing an app that creates personalized meal plans aimed at improving diet quality and supporting weight loss. The app features customizable recipes to suit individual tastes, which may help participants stick with their diets.

Participant Groups

Group I: Intervention arm Experimental Treatment 1 Intervention

These participants will use the app to customize their weekly meal plan and grocery delivery

Group II: comparison Active Control 1 Intervention

These participants will not receive a weekly meal plan and will not get grocery delivery

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Findings from Research

A pilot food prescription program called Fresh Start Food Rx provided biweekly fresh fruits and vegetables and dietary education to four uninsured patients in South Miami, showing potential to improve dietary behaviors and attitudes toward healthy eating.

Participants reported an increase in the number of days they consumed fruits per week and a rise in vegetable servings, indicating that access to healthy foods and education can positively influence eating habits and perceptions about nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. Oliveira, JB., To, L., De La Cruz, Y., et al.[2021]

The 'myfood24 Healthcare' app was found to be acceptable for both patients and healthcare professionals in a feasibility study involving 48 participants from weight management and gastroenterology surgery programs.

Compliance with the app was reasonable, with 50% of users recording their dietary intake for four or more days, indicating potential for effective dietary monitoring and support in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. Threapleton, DE., Beer, SL., Foley, DJ., et al.[2023]

Patients with diabetes expressed frustration over inconsistent dietary advice from healthcare providers and a lack of culturally relevant recommendations, highlighting the need for tailored nutrition guidance.

Registered dietitian nutritionists (RDNs) identified a need for more training in cultural humility and culinary nutrition skills to effectively support low-income, diverse populations in implementing food prescription and culinary medicine programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators of Implementing a Clinic-Integrated Food Prescription Plus Culinary Medicine Program in a Low-Income Food Insecure Population: A Qualitative Study. McWhorter, JW., Danho, MP., LaRue, DM., et al.[2022]

The A Prescription for Healthy Living (APHL) culinary medicine curriculum led to a significant reduction in HbA1c levels among patients with diabetes, indicating improved blood sugar control, with a mean difference of -0.96% (p = 0.028).

Participants in the APHL program reported increased fruit and vegetable consumption, greater confidence in cooking healthy meals, and more frequent cooking from scratch, suggesting positive changes in dietary behaviors and self-efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Culinary Medicine Curriculum on Biometric Outcomes, Dietary Habits, and Related Psychosocial Factors among Patients with Diabetes Participating in a Food Prescription Program. Sharma, SV., McWhorter, JW., Chow, J., et al.[2022]

Outpatient dietitians prioritize long-term lifestyle changes in their nutrition education goals, emphasizing the importance of maintaining a positive relationship with food for their patients.

Dietitians face barriers to optimal app use for nutrition education, but improving app design and providing selection guides could enhance their effectiveness in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone Applications (Apps) for Nutrition Education: A Qualitative Analysis of Outpatient Dietitian Perspectives. Larson, D., Henning, J., Burgermaster, M.[2023]

The Keenoa™ app was preferred over traditional pen and paper methods for diet recording among participants, indicating a positive user experience with digital data collection.

While the app had strengths like picture recognition and a pleasant interface, challenges such as barcode scanning issues and a limited food database were noted, suggesting areas for improvement to enhance its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Diet Tracking Smartphone Application Keenoa™: A Qualitative Analysis. Bouzo, V., Plourde, H., Beckenstein, H., et al.[2022]

The SAlBi educa app, designed with input from healthcare and nutrition professionals, was evaluated for usability and found to be user-friendly, with 94% of participants finding it easy to learn and 59% describing it as pleasant.

In a 1-month pilot test with 39 participants, over 84% reported that the nutritional messages were clear and useful, highlighting the app's potential to effectively promote healthy eating habits based on the Mediterranean diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAlBi educa (Tailored Nutrition App for Improving Dietary Habits): Initial Evaluation of Usability. Gonzalez-Ramirez, M., Cejudo-Lopez, A., Lozano-Navarrete, M., et al.[2023]

The study evaluated the accuracy of food product databases in seven popular diet apps, finding that while 99% of scanned products had energy values available, only 79% of these values were within 5% of the true values, indicating a generally high accuracy for energy reporting.

MyFitnessPal was the most effective app, correctly identifying 96% of products and providing comprehensive nutrient data, while other apps like SparkPeople had significantly lower identification rates, suggesting that not all diet apps are equally reliable for detailed nutrient assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food identification by barcode scanning in the Netherlands: a quality assessment of labelled food product databases underlying popular nutrition applications. Maringer, M., Wisse-Voorwinden, N., Veer, PV'., et al.[2023]

In a randomized trial involving 105 participants, two dietary recording app prototypes were tested for accuracy and efficiency, both achieving over 98% accuracy in recording food intake.

The self-chosen tab app was significantly more time-efficient for inputting food items compared to the autonomous exhaustive list app, although users occasionally missed selecting food attributes, which did not happen with the exhaustive list.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Mobile Health Apps for Customized Dietary Recording for Young Adults and Seniors: Randomized Controlled Trial. Liu, YC., Chen, CH., Tsou, YC., et al.[2020]

The Complete Eats Rx program significantly improved food security and diet quality among SNAP participants by incentivizing the purchase of fruits and vegetables, as reported by 26 participants in qualitative sessions.

Barriers to the program's effectiveness included limited supermarket options for redeeming incentives and challenges related to the cost and accessibility of healthy foods, suggesting that expanding partnerships with more local grocers and improving the shopping experience could enhance program usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Study on Participant Perceptions of a Supermarket Fruit and Vegetable Incentive Program. Riemer, S., Walkinshaw, LP., Auvinen, A., et al.[2023]

A new computer program has been created to help diabetic patients by generating personalized meal plans based on their dietary needs, meal patterns, and food preferences.

The program not only produces daily menus that vary each day but also provides nutrient summaries and shopping lists, making it a comprehensive tool for managing diabetes through diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-planned menus for patients with diabetes mellitus. Wheeler, ML., Wheeler, LA.[2019]

References

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

Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial. [2023]

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

Barriers and Facilitators of Implementing a Clinic-Integrated Food Prescription Plus Culinary Medicine Program in a Low-Income Food Insecure Population: A Qualitative Study. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Culinary Medicine Curriculum on Biometric Outcomes, Dietary Habits, and Related Psychosocial Factors among Patients with Diabetes Participating in a Food Prescription Program. [2022]

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

Smartphone Applications (Apps) for Nutrition Education: A Qualitative Analysis of Outpatient Dietitian Perspectives. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Evaluation of the Diet Tracking Smartphone Application Keenoa™: A Qualitative Analysis. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

SAlBi educa (Tailored Nutrition App for Improving Dietary Habits): Initial Evaluation of Usability. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Food identification by barcode scanning in the Netherlands: a quality assessment of labelled food product databases underlying popular nutrition applications. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Evaluating Mobile Health Apps for Customized Dietary Recording for Young Adults and Seniors: Randomized Controlled Trial. [2020]

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

Qualitative Study on Participant Perceptions of a Supermarket Fruit and Vegetable Incentive Program. [2023]

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

Computer-planned menus for patients with diabetes mellitus. [2019]