FoodRx for Healthy Eating and Weight Loss

(FoodRx Trial)

Overseen By Deborah A Cohen, MD, MPH

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Kaiser Permanente

Must not be taking: Steroids, Antidepressants, Antiseizure

Disqualifiers: Chronic kidney disease, Insulin-dependent diabetes, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 months

720 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an Randomized controlled trial (RCT) to assess the impact of meal planning and affordable grocery delivery on weight loss, dietary quality and health on members of multigenerational Latino households.

Will I have to stop taking my current medications?

The trial requires that you do not use medications that interfere with weight loss, such as steroids, certain anti-depressants, and anti-seizure medications. If you are on these medications, you may need to stop taking them to participate.

What data supports the effectiveness of the treatment FoodRx, Food Prescription, Medically Tailored Nutrition Boxes for healthy eating and weight loss?

Research shows that food prescription programs, which provide access to fresh fruits and vegetables along with dietary education, can improve attitudes toward healthy eating and increase fruit and vegetable consumption, especially in food-insecure communities. Additionally, portion-controlled prepackaged foods have been found to promote more weight and fat loss compared to self-selected diets. ^{1 2 3 4 5}

Is the FoodRx program safe for humans?

The FoodRx program, which involves providing fresh fruits and vegetables along with dietary education, has been implemented in various communities without any reported safety concerns. Participants generally reported positive experiences, suggesting it is safe for human use. ^{3 5 6 7 8}

How is the FoodRx treatment different from other treatments for healthy eating and weight loss?

FoodRx is unique because it provides medically tailored nutrition boxes, focusing on increasing access to fresh fruits and vegetables and offering dietary education, especially for food-insecure communities. Unlike traditional weight loss programs, it combines food delivery with education to promote healthier eating habits and attitudes. ^{1 2 3 5 9}

Research Team

Deborah A Cohen, MD, MPH

Principal Investigator

Kaiser Permanente

Eligibility Criteria

This trial is for multigenerational Latino households with at least two adults wanting to lose weight (BMI >27 kg/m2) and one child aged 5-10. They must have internet access, be willing to pay for groceries, not use certain weight-affecting medications or have specific medical conditions like chronic kidney disease or insulin-dependent diabetes.

Inclusion Criteria

Plans to stay in the area for 12 months

I am willing to pay for my own groceries.

Owns at least 1 smart phone, tablet or computer or has internet access

Exclusion Criteria

I have chronic kidney disease.

Dietary exclusions that are inconsistent with menus

I use insulin to manage my diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly grocery delivery and follow a meal plan for 6 months

6 months

Weekly grocery delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 6 and 12 months

Wait-list control crossover

Control group receives grocery delivery for 6 months after initial 6-month wait period

6 months

Weekly grocery delivery

Treatment Details

Interventions

• FoodRx

Trial Overview The 'FoodRx' program is being tested in this RCT. It involves meal planning and affordable grocery delivery aimed at improving dietary quality, promoting healthy eating habits, and supporting weight loss in participants from multigenerational Latino households.

Participant Groups

Group I: Food Rx- meal plans and groceries Experimental Treatment 1 Intervention

These households will receive grocery delivery weekly for 6 months

Group II: Wait-listed control Active Control 1 Intervention

These households will not receive grocery delivery for the first 6 months, but will get them the second six months after recruitment.

FoodRx is already approved in United States for the following indications:

Approved in United States as FoodRx for:

• Chronic health conditions such as diabetes, high blood pressure, heart disease

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Findings from Research

In a study of 183 adults with overweight or obesity, those who followed a meal plan with portion-controlled prepackaged foods lost significantly more weight (8.6% for regular entrées and 7.8% for higher protein entrées) compared to those on a self-selected diet (6.0%).

Participants using the prepackaged meals also experienced greater fat loss (5.7 kg) than the control group (4.4 kg), indicating that structured meal plans can enhance weight loss outcomes while maintaining meal satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of portion-controlled prepackaged foods to promote weight loss. Rock, CL., Flatt, SW., Pakiz, B., et al.[2022]

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]

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]

Meal replacement products (MRPs) are effective for weight loss in obesity management, but are prescribed to only about 7% of patients by healthcare professionals (HCPs), despite over 70% having prescribed them at some point.

Safety concerns, particularly regarding long-term weight loss durability and the risk of weight cycling, hinder MRP prescriptions; however, HCPs with formal training in MRPs are 66% more likely to prescribe them, indicating that education could improve their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes and Approaches to Use of Meal Replacement Products among Healthcare Professionals in Management of Excess Weight. Maston, G., Franklin, J., Gibson, AA., et al.[2023]

The 'Prevention Produce' program, which combined fruit and vegetable prescriptions with a month-long educational curriculum, successfully increased fruit and vegetable consumption among nine families at risk of chronic disease and food insecurity.

Participants reported a greater understanding of the health benefits of produce, and the mentorship aspect of the program was positively received by both families and medical students, highlighting its potential as a model for integrating preventive health strategies in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. Forbes, JM., Forbes, CR., Lehman, E., et al.[2020]

Participants in the study reported positive experiences with receiving fruit and vegetable prescriptions (FVRx) from their health providers, feeling that it directly supported their health and improved their physical and mental well-being.

Despite the benefits, participants expressed a desire for more choice in the types of fruits and vegetables provided, as well as more flexible pick-up times, indicating areas for improvement in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' experiences with a community fruit and vegetable box program prescribed by their health provider. Johnson, JK., Vingilis, E., Terry, AL.[2023]

In a pilot study involving 172 participants from food-insecure areas, a collaborative food prescription program led to a remarkable 94.1% decrease in food insecurity, highlighting its effectiveness in improving access to nutritious food.

Participants received an average of 29.2 pounds of fresh produce and reported high satisfaction with the program, indicating strong community support and the potential for positive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot food prescription program promotes produce intake and decreases food insecurity. Aiyer, JN., Raber, M., Bello, RS., et al.[2020]

The Food Rx program, a collaborative initiative involving a university, Walgreens, and local health centers, aims to improve healthy eating among diabetes patients in underserved communities by providing food prescriptions that promote behavior change and connect patients to local resources.

Preliminary implementation results suggest that Food Rx effectively integrates community resources into healthcare settings, showing potential as a model for supporting the health of underserved patients, although it is still in the early stages of development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Rx: a community-university partnership to prescribe healthy eating on the South Side of Chicago. Goddu, AP., Roberson, TS., Raffel, KE., et al.[2018]

The introduction of early lifestyle changes, particularly through dietary modifications, is crucial in preventing the progression of diseases like diabetes and obesity, which are becoming increasingly common.

The proposed 3x3x3 dietary prescription is a straightforward and effective tool for healthcare providers, making it easier to teach patients essential dietary principles based on evidence-based guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 3x3x3 diet for the management of diabetes and obesity in resource constrained settings. Kalra, S., Kapoor, L., Kapoor, N.[2022]

References

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

Randomized clinical trial of portion-controlled prepackaged foods to promote weight loss. [2022]

2. 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]

3. 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]

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

Attitudes and Approaches to Use of Meal Replacement Products among Healthcare Professionals in Management of Excess Weight. [2023]

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

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. [2020]

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

Patients' experiences with a community fruit and vegetable box program prescribed by their health provider. [2023]

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

A pilot food prescription program promotes produce intake and decreases food insecurity. [2020]

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

Food Rx: a community-university partnership to prescribe healthy eating on the South Side of Chicago. [2018]

9. Pakistan pubmed.ncbi.nlm.nih.gov

The 3x3x3 diet for the management of diabetes and obesity in resource constrained settings. [2022]