Brief Summary

This study is a virtual, remote, decentralized pragmatic clinical trial comparing the efficacy of medically tailored meals alone or medically tailored meals with remote nutritional counseling compared with usual standard of care in adults with a targeted, nutrition-sensitive chronic medical condition (heart failure, diabetes mellitus, chronic kidney disease).

Trial Health

On Track

Trial Health Score

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

Enrollment

2,000

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline

Completed

Started Apr 2020

Shorter than P25 for not_applicable heart-failure

Geographic Reach

1 country

5 active sites

Status

completed

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

1.4 years study duration

Study Start

First participant enrolled

April 27, 2020

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2021

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed

14 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed

Last Updated

December 22, 2021

Status Verified

December 1, 2021

Enrollment Period

1.4 years

First QC Date

December 8, 2021

Last Update Submit

December 8, 2021

Conditions

Heart Failure Chronic Kidney Diseases Diabetes Mellitus, Type 2

Keywords

Medically Tailored MealsNutritional CounselingFood is Medicine

Outcome Measures

Primary Outcomes (1)

90-day hospitalization for any cause
Occurrence of an acute hospitalization for any reasons within 90-days after discharge from the index hospitalization.
90-days after discharge from the index hospitalization

Secondary Outcomes (8)

90-day hospitalization related to heart failure
90-days after discharge from the index hospitalization
90-day hospitalization related to diabetes
90-days after discharge from the index hospitalization
90-day all-cause mortality
90-days after discharge from the index hospitalization
Patient-reported outcomes
10 weeks after discharge from the index hospitalization
Emergency department visit for any cause
30-, 60- and 90-days after discharge from the index hospitalization
+3 more secondary outcomes

Study Arms (3)

Medically tailored meals only

ACTIVE COMPARATOR

Receive medically-tailored meals only (1 meal per day for total of 10 weeks) customized to the participant's nutrition-sensitive medical condition(s).

Other: Medically tailored meals

Medically tailored meals plus enhanced nutritional counseling

ACTIVE COMPARATOR

Receive medically-tailored meals only (1 meal per day for total of 10 weeks) with up to 3 remotely delivered enhanced nutritional counseling sessions that are customized to the participant's nutrition-sensitive medical condition(s).

Other: Medically tailored meals

Usual care

PLACEBO COMPARATOR

Receive usual standard of care.

Other: Medically tailored meals

Interventions

Medically tailored mealsOTHER

Compare medically tailored meals vs. medically tailored meals with enhanced nutritional counseling vs. usual care

Medically tailored meals onlyMedically tailored meals plus enhanced nutritional counselingUsual care

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Hospitalized at Kaiser Permanente Santa Rosa, Santa Clara, San Francisco, Oakland, or San Rafael Medical Centers
Kaiser Permanente member at admission
Has a prior history of at least one of the following:
Heart failure
Diabetes mellitus
Chronic kidney disease

You may not qualify if:

Receiving primary care at Kaiser Permanente facilities outside of Kaiser Permanente Santa Rosa, Santa Clara, San Francisco, Oakland, or San Rafael Medical Centers
Language interpreter needed
Admitted from skilled nursing facility or nursing home
Homeless at admission
Residence outside the geographic area covered by the medically tailored meals vendors
Prior history of organ transplant

Contact the study team to confirm eligibility.