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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
No dietary exclusions or medical conditions (e.g. chronic kidney disease, or using insulin (those with type 2 diabetes mellitus without needing insulin can participate))
Must not be using medications that interfere with weight loss (e.g., steroids, certain anti-depressants, anti-seizure medications)
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 belowSelect...
I don't have dietary restrictions or chronic kidney disease, and I'm not on insulin.
Select...
I am not taking medications that can prevent weight loss.
Select...
I don't have dietary restrictions or conditions like chronic kidney disease, and I'm not on insulin.
FoodRx Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
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 moreFoodRx 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
393 Previous Clinical Trials
1,220,320 Total Patients Enrolled
Children's Hospital Los AngelesOTHER
236 Previous Clinical Trials
5,076,376 Total Patients Enrolled
Kaiser PermanenteLead Sponsor
541 Previous Clinical Trials
23,906,396 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chronic kidney disease.I am willing to pay for my own groceries.I don't have dietary restrictions or chronic kidney disease, and I'm not on insulin.My family is Latino, has adults wanting to lose weight, and includes members from two or three age groups.I am not taking medications that can prevent weight loss.My Latino family wants to lose weight, includes 2 adults with BMI >27, and has a child aged 5-10.I am on CalFresh and can pick up groceries myself.I don't have dietary restrictions or conditions like chronic kidney disease, and I'm not on insulin.You own a smart phone, tablet or computer or have internet access.You are intending to stay in the country for at least 12 months.I use insulin to manage my diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Food Rx- meal plans and groceries
- Group 2: Wait-listed control
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Eating Patient Testimony for trial: Trial Name: NCT05309395 — Phase 3
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