Clinical trial

Food Prescriptions to Promote Affordable Diets That Meet RDAs Among Multi-generational Latino Households

Name
FoodRx
Description
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.
Trial arms
Trial start
2021-08-21
Estimated PCD
2026-01-15
Trial end
2026-08-31
Status
Recruiting
Phase
Early phase I
Treatment
FoodRx
Participants will receive weekly meal plans and recipes and the groceries required to prepare the recommended meals
Arms:
Food Rx- meal plans and groceries, Wait-listed control
Other names:
Meal planning and grocery delivery
Size
720
Primary endpoint
Weight loss
through study completion, an average of 1 year
Changes in dietary quality
through study completion, an average of 1 year
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 720, 'type': 'ESTIMATED'}}
Updated at
2023-05-09

1 organization

1 product

3 indications

Organization
Kaiser Permanente
Product
FoodRx
Indication
Diet
Indication
Healthy
Indication
Obesity