Nutrition OUtReach In Systems of Healthcare

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-80
SponsorUniversity of Kansas Medical Center

About this trial

Many children and adults receiving medical treatments have higher costs, which can make it harder for them to afford groceries. When someone can't afford enough food, and they do not receive proper nutrition it can make treatment more difficult.

By doing this study investigators hope to learn more about whether addressing food insecurity by giving patients bags of food in clinic can help improve nutrition, reduce costs, and improve transplant and cellular therapy outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Planning to receive transplant or cell therapy

"Within the past 12 months, you worried that your food would run out before you got money to buy more,"

"Within the past 12 months, the food you bought just didn't last and you didn't have money to get more."

Age 8 - 80

Disqualifiers

Patients who do not tolerate oral nutrition at the time of study enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Food Bags

    Other intervention

    Participants will receive bags of shelf-stable food for 2-3 days for one individual twice a week in clinic. They will also receive recipes, handouts, and videos to help with education and food preparation.

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Information GroupNo intervention 0 interventions
Group B: Food Bags GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Peri-Transplant and Cell Therapy Malnutrition

Assessed by Global Leader Initiative on Malnutrition and confirmed by a dietitian

Time frame
Through Day 100

Secondary outcomes

1

Peri-TCT Incidence of Infections

Incidence and subtypes (blood stream, respiratory, or other) of infections captured as standard of care.

Time frame
Through Day 100
2

Peri-TCT Incidence of Acute Graft-vs-Host-Disease

Incidence of acute GVHD captured as standard of care.

Time frame
Through Day 180
3

Peri-TCT Incidence of Chronic Graft-vs-Host Disease

Incidence of chronic GVHD captured as standard of care.

Time frame
Through Year 1
4

Incidence of Relapse

Incidence of relapse captured as standard of care.

Time frame
Through Year 1

Other outcomes

1

Muscle Health

Muscle health as assessed by MuscleSound, which quantifies changes in intramuscular adipose tissue (kg).

Time frame
At Day 100 and at Year 1
2

Muscle Health

Muscle health as assessed by MuscleSound, which quantifies changes in glycogen stores (g).

Time frame
At Day 100 and at Year 1
3

Muscle Health

Muscle health as assessed by MuscleSound, which quantifies changes in muscle wasting using the Skeletal Muscle Index (SMI), with a higher number representing greater muscle mass.

Time frame
At Day 100 and at Year 1
4

Muscle Health

Muscle health as assessed by MuscleSound, which quantifies changes in the presence or absence of sarcopenia.

Time frame
At Day 100 and at Year 1

Sponsors and contacts

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

University of Kansas Medical Center

Lead sponsor

Duke University

Collaborator

Stanford University

Collaborator

Memorial Sloan Kettering Cancer Center

Collaborator

National Institute of Nursing Research (NINR)

Collaborator