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Purpose

Purpose of the Study: This clinical trial will test whether a nutrition and kidney health program can work well for adults with kidney disease. The program was created with help from patients and community partners. Main Questions: How many eligible patients choose to join the program? How many participants complete all 7 educational sessions? How satisfied are participants with the program? What Participants Will Do: Participants will be assigned to a diet-focused lifestyle education series (THINK-Well Intervention) or enhance usual care. THINK-Well Intervention group will take part in 7 group education sessions over 12-20 weeks. Sessions will be online and in-person. Topics include eating to promote heart-kidney-and metabolic health, managing long-term health conditions, setting health goals, and sharing experiences with others who have chronic disease. Participants will practice meal preparation through cooking classes and have opportunity to apply lessons on choosing whole foods with food bucks provided. The enhanced usual care group will receive two virtual nutrition education sessions led by a trained educator over 12-20 weeks. Topics will be similar to standard education provided to people with kidney disease managed by a kidney doctor. Topics will be adapted from established resources from the National Kidney Foundation, American Kidney Fund, and American Heart Association.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult (age ≥ 18 years) patients of UPMC Clinic and the presence of non-dialysis CKD defined by lab values eGFR ≤ 60 ml/min/1.73m2 and any level of proteinuria (or albuminuria); or eGFR > 60 and urine-protein-to-creatinine ratio or urine-albumin-to-creatinine ratio > 30mg/g), and at least one of the following: uncontrolled diabetes (HbA1c ≥ 7.5%), hypertension (12-month average blood pressure ≥130/80 mmHg), overweight or obese body mass index, or positive screening for food insecurity. - Individuals meeting inclusion criteria will be screened for readiness to change by research coordinator. Individuals in contemplation, preparation, action, and maintenance stages of change will be eligible for enrollment.

Exclusion Criteria

  • To minimize attrition, individuals on dialysis, or planned to start dialysis or receive kidney transplant in the next 6 months will be excluded. - A larger effectiveness trial will include persons in all stages of change, but this study will exclude those in pre-contemplative stage of change because low commitment to the trial may interfere with primary goal to measure feasibility. - We are excluding participants who have no electronic health record data within the last 18 months. Specifically, no office visits, kidney function labs (i.e.. eGFR, uACR, and uPCR values), or documentation of CKD (stage 3 or higher) or proteinuria. We believe that patients without this data will be less likely to have the necessary lab data we are collecting for the pre- and post- intervention periods.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
THINK-Well 		Hybrid (in-person and virtual) practical nutrition education with people living with kidney disease. Group sessions will enable social support from others with kidney disease, facilitate goal-setting and individualized problem-solving, discuss an integrated approach to nutrition for people with multiple health conditions, and develop basic culinary skills while encouraging a whole-food, heart-healthy diet. Participants will also receive financial assistance to purchase produce and opt-out 1:1 nutrition counseling.
  • Behavioral: THINK-Well
    Seven hybrid (online or in-person) group nutrition education sessions paired with food bucks and one individual consultation with a dietitian over 12-20 weeks.
Active Comparator
Enhanced Usual Care 		The enhanced usual care group will receive two virtual nutrition education sessions led by a trained educator over 12-20 weeks.
  • Other: Enhanced Usual Care
    Two virtual group nutrition educational sessions provided by a trained educator.

Recruiting Locations

UPMC Kidney Clinic - Wexford
Pittsburgh, Pennsylvania 15090
Contact:
Linda-Marie Lavenburg, DO
412-663-5528
lavenburglu@upmc.edu

UPMC Kidney Clinic - Monroeville
Pittsburgh, Pennsylvania 15146
Contact:
Christopher Passero, MD
412-578-9551
passerocj@upmc.edu

UPMC Kidney Clinic - Oakland
Pittsburgh, Pennsylvania 15213
Contact:
Jyotsana Thakkar, MD
412-756-3228
thakkarj@upmc.edu

UPMC Kidney Clinic - Shadyside
Pittsburgh, Pennsylvania 15232
Contact:
Christopher Passero, MD
412-578-9551
passerocj@upmc.edu

More Details

Status
Recruiting
Sponsor
University of Pittsburgh

Study Contact

Linda-Marie Lavenburg, DO, MS
12679807722
lavenburglu@upmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.