NCT05562180

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 8, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

September 28, 2022

Last Update Submit

July 8, 2024

Conditions

Diet, Healthy

Outcome Measures

Primary Outcomes (1)

  • Dietary Quality

    HEI (Healthy Eating Index)

    1 month

Secondary Outcomes (1)

  • weight loss

    1 month

Study Arms (2)

Intervention arm

EXPERIMENTAL

These participants will use the app to customize their weekly meal plan and grocery delivery

Behavioral: Customized meal plan and grocery delivery

comparison

NO INTERVENTION

These participants will not receive a weekly meal plan and will not get grocery delivery

Interventions

Customized meal plan and grocery deliveryBEHAVIORAL

Participants will use an app to customize their meal plans

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not enrolled in Food Rx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente

Pasadena, California, 91101, United States

RECRUITING

Central Study Contacts

Kelly Lopez, MPH

CONTACT

(626) 564-7752kelly.e.lopez@kp.org

Deborah A Cohen, MD, MPH

CONTACT

626 564 7705deborah.a.cohen@kp.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

September 28, 2022

First Posted

September 30, 2022

Study Start

April 8, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)