search
Back to results

Food Prescriptions to Promote Affordable Diets (FoodRx)

Primary Purpose

Diet, Healthy, Overweight and Obesity

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
FoodRx
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diet, Healthy

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 ages 5-10 years; [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

Sites / Locations

  • Kaiser PermanenteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Food Rx- meal plans and groceries

Wait-listed control

Arm Description

These households will receive grocery delivery weekly for 6 months

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

Outcomes

Primary Outcome Measures

Weight loss
Changes in BMI
Changes in dietary quality
Participants will complete the ASA24-2020

Secondary Outcome Measures

Change in HbA1C
biomarker of blood glucose
Change in SGOT/PT
Liver function tests
Change in Cholesterol
level of cholesterol
Change in Systolic and diastolic blood pressure
Blood pressure

Full Information

First Posted
February 14, 2022
Last Updated
May 8, 2023
Sponsor
Kaiser Permanente
Collaborators
Children's Hospital Los Angeles, National Institute on Minority Health and Health Disparities (NIMHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT05309395
Brief Title
Food Prescriptions to Promote Affordable Diets
Acronym
FoodRx
Official Title
Food Prescriptions to Promote Affordable Diets That Meet RDAs Among Multi-generational Latino Households
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2021 (Actual)
Primary Completion Date
January 15, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Children's Hospital Los Angeles, National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, Healthy, Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Food Rx- meal plans and groceries
Arm Type
Experimental
Arm Description
These households will receive grocery delivery weekly for 6 months
Arm Title
Wait-listed control
Arm Type
Active Comparator
Arm Description
These households will not receive grocery delivery for the first 6 months, but will get them the second six months after recruitment.
Intervention Type
Combination Product
Intervention Name(s)
FoodRx
Other Intervention Name(s)
Meal planning and grocery delivery
Intervention Description
Participants will receive weekly meal plans and recipes and the groceries required to prepare the recommended meals
Primary Outcome Measure Information:
Title
Weight loss
Description
Changes in BMI
Time Frame
through study completion, an average of 1 year
Title
Changes in dietary quality
Description
Participants will complete the ASA24-2020
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Change in HbA1C
Description
biomarker of blood glucose
Time Frame
6 months
Title
Change in SGOT/PT
Description
Liver function tests
Time Frame
6 months
Title
Change in Cholesterol
Description
level of cholesterol
Time Frame
6 months
Title
Change in Systolic and diastolic blood pressure
Description
Blood pressure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah A Cohen, MD, MPH
Phone
3107953960
Email
deborah.a.cohen@kp.org
First Name & Middle Initial & Last Name or Official Title & Degree
Galina Inzhakova
Phone
6267105792
Email
galina.inzhakova@kp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah A Cohen, MD,MPH
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
Pasadena
State/Province
California
ZIP/Postal Code
91101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galina INzhakova, MPH
Phone
626-564-7752
Email
galina.inzhkova@kp.org
First Name & Middle Initial & Last Name & Degree
Erika Estrada, MPH
Email
erika.l.estrada@kp.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Food Prescriptions to Promote Affordable Diets

We'll reach out to this number within 24 hrs