Recruiting
Phase 3

Observational Study

Sponsor:

Kaiser Permanente

Code:

NCT05309395

Conditions

Diet, Healthy

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

FoodRx

Study Details

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.

Conditions

Diet, Healthy

Overweight and Obesity

Study ID

NCT05309395

Start date

Aug 21, 2021

Status verified date

Apr, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

720 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Food Rx- meal plans and groceries

These households will receive grocery delivery weekly for 6 months

active comparator: Wait-listed control

These households will not receive grocery delivery for the first 6 months, but will get them the second six months after recruitment.

Interventions

FoodRx

Participants will receive weekly meal plans and recipes and the groceries required to prepare the recommended meals

Primary outcome measure

  • Weight loss [ Time Frame: through study completion, an average of 1 year ]
  • Changes in dietary quality [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Deborah A Cohen, MD, MPH

3107953960deborah.a.cohen@kp.org

Galina Inzhakova

6267105792galina.inzhakova@kp.org

Locations

Kaiser Permanente

Recruiting

Pasadena, California, United States, 91101

Contacts

Galina INzhakova, MPH

6265647752galina.inzhkova@kp.org

Erika Estrada, MPH

erika.l.estrada@kp.org

More Information

Sponsor

Kaiser Permanente

Last update posted

Apr 29, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2025-04-29.