FOOD PRESCRIPTION APP

FOOD PRESCRIPTION APP TO EXTEND AND CUSTOMIZE HEALTHY MEALS FOR A BETTER DIET

This study will develop and test and app that will create meal plans to improve diet quality and support weight loss. This app will allow participants to customize their meal plans and substitute recipes for nutritionally equivalent options that they find more appealing, thus potentially increasing adherence.

Study Overview

• Status: Recruiting
• Conditions: Diet, Healthy
• Intervention / Treatment: Behavioral: Customized meal plan and grocery delivery

Detailed Description

We are specifically planning app to create meal plans that are affordable, meet the recommended dietary allowances (RDAs) and adhere to sustainability guidelines to reduce the food-related carbon footprint. The app will enable participants to customize their weekly meal plans. We hypothesize that having the ability to customize the weekly menus through a FoodRx app will improve outcomes, as the lack of customization appeared to be a barrier for some families to improve their diet quality and achieve weight loss goals. (eg, some families did not like tofu or oatmeal, and would have preferred a substitute). We will be able to test the impact of the Food Rx app by comparing participants who use it to our control group that does not currently have access to the standard menus/grocery delivery or FoodRx app.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Deborah A Cohen, MD, MPH; Phone Number: 626 564 7705; Email: deborah.a.cohen@kp.org
• Study Contact Backup: Name: Kelly Lopez, MPH; Phone Number: (626) 564-7752; Email: kelly.e.lopez@kp.org

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91101
      • Recruiting
      • Kaiser Permanente
      • Contact: Deborah A Cohen, MD, MPH; Phone Number: 626-564-7705; Email: deborah.a.cohen@kp.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Already enrolled in FoodRx study >18 years BMI>27 and wants to lose weight -

Exclusion Criteria:

Not enrolled in Food Rx

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; These participants will use the app to customize their weekly meal plan and grocery delivery	Behavioral: Customized meal plan and grocery delivery; Participants will use an app to customize their meal plans
No Intervention: comparison; These participants will not receive a weekly meal plan and will not get grocery delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Quality	HEI (Healthy Eating Index)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight loss	BMI will be measured	1 month

Collaborators and Investigators

• Sponsor: Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 3P50MD017344-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No