Diet, HealthyPhase 3FoodRxNCT05309395
Food Prescriptions to Promote Affordable Diets
A Phase 3 study testing FoodRx in people with Diet, Healthy and Overweight and Obesity, run by Kaiser Permanente at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Overweight and Obesity
- What is being tested?
- FoodRx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2021to 1 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Multigenerational Latino household that has at least 2 adults with a BMI >27 kg/m2 and who both want to lose weight and at least one child under age 18; [Multi-generational is defined as having household members in two or three age groups: a) less than 18 years; b) 18-64 years; c) 65 years or older]; The household should have between 3-5 residents.
- Owns at least 1 smart phone, tablet or computer or has internet access;
- 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)
- Plans to stay in the area for 12 months;
- Must not be using medications that interfere with weight loss (e.g., steroids, certain anti-depressants, anti-seizure medications),
- Willing to pay for groceries
- If on Calfresh, must be willing to pick up groceries at the store.
Who cannot join
- Chronic kidney disease,
- insulin dependent diabetes,
- dietary exclusions that are inconsistent with menus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kaiser Permanente
Pasadena, California, 91101
Galina INzhakova, MPH, 6265647752, galina.inzhkova@kp.org
Erika Estrada, MPH, erika.l.estrada@kp.org
About this study
Official title: Food Prescriptions to Promote Affordable Diets That Meet RDAs Among Multi-generational Latino Households
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.
Read the detailed description
FoodRx will test the effects of a culturally sensitive meal planning and affordable grocery delivery service in a randomized controlled trial to improve diet quality, weight control and chronic disease risk among multi-generational Latino households. This will be the first study to test the effectiveness of food prescriptions and home delivery on BMI and diet quality among Latino families. Food prescriptions will meet the EAT-Lancet sustainability guidelines and achieve at least 90% of the recommended dietary allowances (RDAs) for 23 critical nutrients for all family members at a cost not exceeding $680/month, the current CalFresh [California's Supplemental Nutrition Assistance Program (SNAP)] budget allocated for a family of four. Investigators will include tailored directions on portion size based on age, sex, activity level and weight goals. Investigators will develop and validate our menus and test logistics with focus groups of Latino adults with overweight or obesity [Body mass index (BMI) >25 kg/m2]. Thereafter, 180 Latino households of 3-5 people (n=720) from Kaiser Permanente members with at least two individuals with overweight or obese and at least 1 child aged 5-10 years will participate in a 6-month randomized trial with a wait-list cross-over design. Based on the weekly menu plan, a grocery list will be generated, and items delivered to the home. Anthropometric measurements, blood pressure, and dietary intake and blood samples will be collected at baseline, 6, and 12 months. Each family will be expected to pay for the majority of grocery costs, with the amount above this covered as an incentive for participation. Specific aims are: 1. To develop an affordable and culturally sensitive meal-planning and grocery delivery intervention for Latino households. 2) To determine the impact of food prescriptions and grocery delivery on parental health and diet quality. 3) To determine the impact of food prescriptions and grocery delivery on child health and diet quality. In a cross-center aim, data from this Project will be combined with Projects 1 and 2 to examine 1) the multi-level determinants of chronic disease risk in Latino children and 2) the effects of different types of interventions and how social and environmental factors in Latino affect the response to intervention.
Measure include BMI for adults and BMI z-score (primary outcome) for children, dietary quality, cognitive function in children, blood pressure, HbA1C, blood lipids and liver function (ALT/AST) (secondary outcomes) and compare intervention with wait-list control participants. If the approach proves effective, food prescriptions could provide a scalable and sustainable model to improve the diet, health, and well-being of Latino families.
- Conditions
- Diet, Healthy, Overweight and Obesity
- Being tested
- FoodRx
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodRxCombination product
Also called Meal planning and grocery delivery
Participants will receive weekly meal plans and recipes and the groceries required to prepare the recommended meals
| Study group | Role | What they receive |
|---|---|---|
| Food Rx- meal plans and groceries | Experimental | These households will receive grocery delivery weekly for 6 months Receives: Combination Product: FoodRx |
| Wait-listed control | Active comparator | These households will not receive grocery delivery for the first 6 months, but will get them the second six months after recruitment. Receives: Combination Product: FoodRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Changes in BMI
Measured: through study completion, an average of 1 year
Changes in dietary quality
Participants will complete the ASA24-2020
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Change in HbA1C
biomarker of blood glucose
Measured: 6 months
Change in SGOT/PT
Liver function tests
Measured: 6 months
Change in Cholesterol
level of cholesterol
Measured: 6 months
Change in Systolic and diastolic blood pressure
Blood pressure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start21 Aug 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Deborah A Cohen, MD,MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309395
- Sponsor's protocol ID
- FoodRx
- Other IDs
- P50MD017344
- Acronym
- FoodRx
- Status last verified
- Apr 2025
- First submitted
- 14 Feb 2022
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Prescriptions to Promote Affordable Diets That Meet RDAs Among Multi-generational Latino Households
- ClinicalTrials.gov ID
- NCT05309395
- Acronym / sponsor ID
- FoodRx / FoodRx
- Conditions
- Diet, Healthy, Overweight and Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
FoodRx will test the effects of a culturally sensitive meal planning and affordable grocery delivery service in a randomized controlled trial to improve diet quality, weight control and chronic disease risk among multi-generational Latino households. This will be the first study to test the effectiveness of food prescriptions and home delivery on BMI and diet quality among Latino families. Food prescriptions will meet the EAT-Lancet sustainability guidelines and achieve at least 90% of the recommended dietary allowances (RDAs) for 23 critical nutrients for all family members at a cost not exceeding $680/month, the current CalFresh [California's Supplemental Nutrition Assistance Program (SNAP)] budget allocated for a family of four. Investigators will include tailored directions on portion size based on age, sex, activity level and weight goals. Investigators will develop and validate our menus and test logistics with focus groups of Latino adults with overweight or obesity [Body mass index (BMI) >25 kg/m2]. Thereafter, 180 Latino households of 3-5 people (n=720) from Kaiser Permanente members with at least two individuals with overweight or obese and at least 1 child aged 5-10 years will participate in a 6-month randomized trial with a wait-list cross-over design. Based on the weekly menu plan, a grocery list will be generated, and items delivered to the home. Anthropometric measurements, blood pressure, and dietary intake and blood samples will be collected at baseline, 6, and 12 months. Each family will be expected to pay for the majority of grocery costs, with the amount above this covered as an incentive for participation. Specific aims are: 1. To develop an affordable and culturally sensitive meal-planning and grocery delivery intervention for Latino households. 2) To determine the impact of food prescriptions and grocery delivery on parental health and diet quality. 3) To determine the impact of food prescriptions and grocery delivery on child health and diet quality. In a cross-center aim, data from this Project will be combined with Projects 1 and 2 to examine 1) the multi-level determinants of chronic disease risk in Latino children and 2) the effects of different types of interventions and how social and environmental factors in Latino affect the response to intervention.
Measure include BMI for adults and BMI z-score (primary outcome) for children, dietary quality, cognitive function in children, blood pressure, HbA1C, blood lipids and liver function (ALT/AST) (secondary outcomes) and compare intervention with wait-list control participants. If the approach proves effective, food prescriptions could provide a scalable and sustainable model to improve the diet, health, and well-being of Latino families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food Rx- meal plans and groceries | Experimental | Combination Product: FoodRxThese households will receive grocery delivery weekly for 6 months |
| Wait-listed control | Active comparator | Combination Product: FoodRxThese households will not receive grocery delivery for the first 6 months, but will get them the second six months after recruitment. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Multigenerational Latino household that has at least 2 adults with a BMI >27 kg/m2 and who both want to lose weight and at least one child under age 18; [Multi-generational is defined as having household members in two or three age groups: a) less than 18 years; b) 18-64 years; c) 65 years or older]; The household should have between 3-5 residents.
- Owns at least 1 smart phone, tablet or computer or has internet access;
- 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)
- Plans to stay in the area for 12 months;
- Must not be using medications that interfere with weight loss (e.g., steroids, certain anti-depressants, anti-seizure medications),
Key exclusion criteria (3 listed)
- Chronic kidney disease,
- insulin dependent diabetes,
- dietary exclusions that are inconsistent with menus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoodRxAlso: Meal planning and grocery deliveryParticipants will receive weekly meal plans and recipes and the groceries required to prepare the recommended meals | Combination product | Food Rx- meal plans and groceries, Wait-listed control |
Primary outcome
Weight loss
Time frame: through study completion, an average of 1 year
Changes in BMI
Changes in dietary quality
Time frame: through study completion, an average of 1 year
Participants will complete the ASA24-2020
4 secondary outcomes
Change in HbA1C
Time frame: 6 months
Change in SGOT/PT
Time frame: 6 months
Change in Cholesterol
Time frame: 6 months
Change in Systolic and diastolic blood pressure
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah A Cohen, MD,MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FoodRx in people with Diet, Healthy and Overweight and Obesity, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah A Cohen, MD, MPH (3107953960, deborah.a.cohen@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.