Comprehensive Support Program for Chronic Kidney Disease

Recruiting at 2 trial locations

Overseen By Nicole Clark, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must not be taking: NSAIDs, Mineralocorticoids, Warfarin, others

Disqualifiers: CKD 4, ESRD, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

330 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications that affect potassium metabolism, such as NSAIDs, mineralocorticoid receptor antagonists, and Warfarin. If you are taking these medications regularly, you may need to stop them to participate.

What data supports the effectiveness of this treatment for chronic kidney disease?

The research suggests that personalized and practical support, like having a dedicated health partner, can improve adherence to dietary advice in chronic kidney disease patients. Additionally, providing emotional support and practical tips through trained mentors has been effective in other health conditions, indicating potential benefits for kidney disease patients as well. ^{1 2 3 4 5}

Is the Comprehensive Support Program for Chronic Kidney Disease safe for humans?

The available research on similar programs, like produce prescription and meal-kit programs, suggests they are generally safe for humans. Participants in these studies reported satisfaction and positive experiences, with no significant safety concerns mentioned. ^{6 7 8 9 10}

How is this treatment for chronic kidney disease different from other treatments?

This treatment is unique because it combines personalized support with practical resources like grocery store gift cards, produce delivery, and customized recipes, focusing on lifestyle changes rather than medication. It emphasizes emotional and practical support through a dedicated health partner, which is not typically part of standard CKD treatments. ^{11 12 13 14 15}

What is the purpose of this trial?

This two-arm, parallel randomized trial study will assess the efficacy of a 6-month (26 weeks) community-based program in reducing kidney injury (as Urine Albumin to Creatinine ratio, uACR), cardiovascular risk (as Hemoglobin A1C and blood pressure), mental health (as PHQ-8) and diet quality (as fruits and vegetables intake and Healthy Eating Index) in community-dwelling, low-income adults diagnosed with early chronic kidney disease (stages 2 or 3 and not on kidney replacement therapies) compared to educational materials and usual care alone.

Research Team

Maninder Kahlon, PhD

Principal Investigator

University of Texas at Austin

Eligibility Criteria

Adults with early-stage chronic kidney disease (stages 2 or 3), not on dialysis, who speak English or Spanish, can prepare and store food, have SMS access, live in the delivery zone of certain clinics, and have visited one of three partner clinics within the last 18 months. Excludes those with advanced CKD, on Warfarin or certain other medications, recent severe cardiovascular events or procedures.

Inclusion Criteria

I have visited this clinic before, at least once in the last 18 months.

I have chronic kidney disease in stages 2, 3a, or 3b.

Ability to participate in the program at least 6 months

Exclusion Criteria

My doctor has diagnosed me with advanced liver disease.

I haven't had a heart attack, unstable angina, stroke, or TIA in the last 3 months.

You are currently receiving hospice care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month community-based program including delivery of kidney-friendly produce, grocery store e-gift cards, educational materials, and support from a Health Partner

26 weeks

Regular contact through phone calls and SMS texts

Follow-up

Participants are monitored for changes in kidney injury markers, cardiovascular risk, diet quality, and mental health

4 weeks

Treatment Details

Interventions

• E-gift cards to a grocery store of choice
• Personalized practical & emotional support through a dedicated health partner
• Produce delivery + Recipes customized to produce
• Welcome information (phone or text)
• Welcome package

Trial Overview The trial is testing a community-based program that includes personalized support from a health partner, produce deliveries with customized recipes, welcome package and information via phone/text, and grocery e-gift cards against usual care. The study measures effects on kidney injury markers like uACR as well as cardiovascular risk factors.

Participant Groups

Group I: Arm 2: Educational materials + usual care Experimental Treatment 2 Interventions

1. Welcome package 2. Welcome information: SMS/Text

Group II: Arm 1: Intervention + usual care Experimental Treatment 5 Interventions

1. Welcome package 2. Welcome information: telephone call 3. Produce delivered at their choice of time and location + Recipes customized to produce 4. E-gift cards to a grocery store of choice 5. Personalized practical, emotional \& educational support through a dedicated health partner

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Harris Health

Collaborator

Trials

3

Recruited

1,500+

Findings from Research

Patients with chronic renal disease should receive comprehensive counseling and educational support to enhance their quality of life.

Healthcare systems need to develop educational programs that utilize existing staff resources, as no additional funding has been allocated for patient education in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient education]. Tourette-Turgis, C., Isnard-Bagnis, C.[2013]

The 'Prevention Produce' program, which combined fruit and vegetable prescriptions with a month-long educational curriculum, successfully increased fruit and vegetable consumption among nine families at risk of chronic disease and food insecurity.

Participants reported a greater understanding of the health benefits of produce, and the mentorship aspect of the program was positively received by both families and medical students, highlighting its potential as a model for integrating preventive health strategies in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. Forbes, JM., Forbes, CR., Lehman, E., et al.[2020]

Health care providers involved in produce prescription projects reported operational challenges such as time constraints, difficulties in engaging patients, and barriers to data sharing, which were exacerbated by the COVID-19 pandemic.

Despite these challenges, providers expressed satisfaction with the projects due to positive patient outcomes, including improved food security and clinical results, highlighting the need for dedicated staff and rigorous program evaluation to ensure sustainability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Produce prescription projects: Challenges, solutions, and emerging best practices - Perspectives from health care providers. Stotz, SA., Budd Nugent, N., Ridberg, R., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Strategies to promote adherence to nutritional advice in patients with chronic kidney disease: a narrative review and commentary. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Patient education]. [2013]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators of Fruit and Vegetable Consumption in Renal Transplant Recipients, Family Members and Healthcare Professionals-A Focus Group Study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Trained ESRD mentors: an important resource for total patient care. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Multiple factors affect renal dietitians' use of the NKF-K/DOQI Adult Nutrition Guidelines. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Inclusion of Food Safety Information in Home-delivered U.K. Meal-kit Recipes. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The East Side Table Make-at-Home Meal-Kit Program is feasible and acceptable: A pilot study. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a Home-Delivery Produce Prescription Program to Address Food Insecurity and Diet Quality in Adults and Children. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Produce prescription projects: Challenges, solutions, and emerging best practices - Perspectives from health care providers. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Self-management interventions for adults with chronic kidney disease: a scoping review. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

A VA Health Care Innovation: Healthier Kidneys Through Your Kitchen-Earlier Nutrition Intervention for Chronic Kidney Disease. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Nutritional Mobile Applications for CKD Patients: Systematic Review. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Multinutrient oral supplements and tube feeding in maintenance dialysis: a systematic review and meta-analysis. [2018]

15. Netherlands pubmed.ncbi.nlm.nih.gov

A population health dietary intervention for African American adults with chronic kidney disease: The Fruit and Veggies for Kidney Health randomized study. [2022]