NCT05309395 Food Prescriptions to Promote Affordable Diets
| NCT ID | NCT05309395 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Kaiser Permanente |
| Condition | Diet, Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 720 participants |
| Start Date | 2021-08-21 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 720 participants in total. It began in 2021-08-21 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Chronic kidney disease, * insulin dependent diabetes, * dietary exclusions that are inconsistent with menus
Contact & Investigator
Deborah A Cohen, MD,MPH
PRINCIPAL INVESTIGATOR
Kaiser Permanente
Frequently Asked Questions
Who can join the NCT05309395 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Diet, Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05309395 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 720 participants.
Is NCT05309395 currently recruiting?
Yes, NCT05309395 is actively recruiting participants. Contact the research team at deborah.a.cohen@kp.org for enrollment information.
Where is the NCT05309395 trial being conducted?
This trial is being conducted at Pasadena, United States.
Who is sponsoring the NCT05309395 clinical trial?
NCT05309395 is sponsored by Kaiser Permanente. The principal investigator is Deborah A Cohen, MD,MPH at Kaiser Permanente. The trial plans to enroll 720 participants.