Food Prescriptions to Promote Affordable Diets

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2+
SponsorKaiser Permanente

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

Chronic kidney disease,

insulin dependent diabetes,

dietary exclusions that are inconsistent with menus

Trial design

Design model

Crossover

Treatments tested in this trial

  • FoodRx

    Combination product

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

Treatment groups

720 Participants
are divided into 2 treatment groups
Group A: Food Rx- meal plans and groceriesExperimental treatment 1 intervention
Group B: Wait-listed controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Weight loss

Changes in BMI

Time frame
through study completion, an average of 1 year
2

Changes in dietary quality

Participants will complete the ASA24-2020

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Change in HbA1C

biomarker of blood glucose

Time frame
6 months
2

Change in SGOT/PT

Liver function tests

Time frame
6 months
3

Change in Cholesterol

level of cholesterol

Time frame
6 months
4

Change in Systolic and diastolic blood pressure

Blood pressure

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kaiser Permanente

Lead sponsor

Children's Hospital Los Angeles

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator