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Behavioural Intervention

FoodRx for Healthy Eating and Weight Loss (FoodRx Trial)

Phase 3
Recruiting
Led By Deborah A Cohen, MD,MPH
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not be using medications that interfere with weight loss (e.g., steroids, certain anti-depressants, anti-seizure medications)
Willing to pay for groceries
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

FoodRx Trial Summary

This trial will assess the impact of meal planning and grocery delivery on weight loss, dietary quality and health for Latino households.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the intervention involves diet modification rather than medication, typical drug side effects are not expected. However, changes in diet can sometimes cause digestive discomfort as the body adjusts to new foods.

FoodRx Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not taking medications that can prevent weight loss, like steroids or certain anti-depressants.
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I am willing to pay for my own groceries.
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I am willing to pay for my own groceries.
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I don't have dietary restrictions or chronic kidney disease, and I'm not on insulin.
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My family is Latino, has adults wanting to lose weight, and includes members from two or three age groups.
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I am not taking medications that can prevent weight loss.
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My Latino family wants to lose weight, includes 2 adults with BMI >27, and has a child aged 5-10.
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I am on CalFresh and can pick up groceries myself.
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I don't have dietary restrictions or conditions like chronic kidney disease, and I'm not on insulin.

FoodRx Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in dietary quality
Weight loss
Secondary outcome measures
Change in Cholesterol
Change in HbA1C
Change in SGOT/PT
+1 more

FoodRx Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Food Rx- meal plans and groceriesExperimental Treatment1 Intervention
These households will receive grocery delivery weekly for 6 months
Group II: Wait-listed controlActive Control1 Intervention
These households will not receive grocery delivery for the first 6 months, but will get them the second six months after recruitment.

Find a Location

Who is running the clinical trial?

National Institute on Minority Health and Health Disparities (NIMHD)NIH
376 Previous Clinical Trials
1,214,436 Total Patients Enrolled
Children's Hospital Los AngelesOTHER
230 Previous Clinical Trials
5,075,722 Total Patients Enrolled
Kaiser PermanenteLead Sponsor
537 Previous Clinical Trials
24,112,616 Total Patients Enrolled

Media Library

FoodRx (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05309395 — Phase 3
Healthy Eating Research Study Groups: Food Rx- meal plans and groceries, Wait-listed control
Healthy Eating Clinical Trial 2023: FoodRx Highlights & Side Effects. Trial Name: NCT05309395 — Phase 3
FoodRx (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05309395 — Phase 3
Healthy Eating Patient Testimony for trial: Trial Name: NCT05309395 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the goals that this research is trying to achieve?

"The lead goal of this one-year long study is to monitor changes in dietary quality. Additionally, the research team will also be tracking HbA1C levels (a biomarker for blood sugar), SGOT/PT (liver function tests), and systolic & diastolic blood pressure."

Answered by AI

How does FoodRx compare to other medications in terms of safety for patients?

"FoodRx's safety is estimated to be a 3. This is based on the fact that it is a Phase 3 trial, which means there is both efficacy and safety data available."

Answered by AI

How many total participants are included in this research project?

"The research team is currently looking for 720 individuals to participate in this clinical trial, which was first posted on August 21st, 2021. The study's most recent update occurred on September 29th, 2022."

Answered by AI

Are there any patients currently being enrolled in this clinical trial?

"This trial, as indicated by clinicaltrials.gov, is still recruiting patients. The 8/21/2021 date refers to when the study was first posted and 9/29/2022 is when information about the trial was last updated."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Kaiser Permanente
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

My weight keeps creeping up. Because wanted to learn ore about the study.
PatientReceived 2+ prior treatments
~291 spots leftby Jan 2026