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FoodRx for Healthy Eating and Weight Loss (FoodRx Trial)
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.
FoodRx Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFoodRx Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FoodRx Trial Design
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Who is running the clinical trial?
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- I have chronic kidney disease.I am not taking medications that can prevent weight loss, like steroids or certain anti-depressants.I am willing to pay for my own groceries.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.
- Group 1: Food Rx- meal plans and groceries
- Group 2: Wait-listed control
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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