Feasibility of The Health Integrated Nutrition and Kidney Wellness Program

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07518719
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • THINK-Well — BEHAVIORAL
    Seven hybrid (online or in-person) group nutrition education sessions paired with food bucks and one individual consultation with a dietitian over 12-weeks.
  • Enhanced Usual Care — OTHER
    Two virtual group nutrition educational sessions provided by a trained educator.

Study Details

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 finish the full 12-week program? 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 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 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.

Key Dates

Start date
Apr 24, 2026
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.
  • Active Comparator: Enhanced Usual Care
    The enhanced usual care group will receive two virtual nutrition education sessions led by a trained educator over 12 weeks.

Primary Outcome Measure

Feasibility of Recruitment [ Time Frame: During the study recruitment period (anticipated up to 6 months) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
UPMC Kidney Clinic - MonroevillePittsburghPennsylvania15146
Christopher Passero, MD
[email protected]
412-578-9551
UPMC Kidney Clinic - OaklandPittsburghPennsylvania15213
Jyotsana Thakkar, MD
[email protected]
412-756-3228
UPMC Kidney Clinic - ShadysidePittsburghPennsylvania15232
Christopher Passero, MD
[email protected]
412-578-9551
UPMC Kidney Clinic - WexfordPittsburghPennsylvania15090
Linda-Marie Lavenburg, DO
[email protected]
412-663-5528
UPMC Matilda H. Theiss Health CenterPittsburghPennsylvania15219
Mylynda Massart, MD, PhD
[email protected]
412-647-9304

Find similar trials in Pittsburgh, PA

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
UPMC Kidney Clinic - Monroeville· Pittsburgh, PAUPMC Kidney Clinic - Oakland· Pittsburgh, PAUPMC Kidney Clinic - Shadyside· Pittsburgh, PAUPMC Kidney Clinic - Wexford· Pittsburgh, PAUPMC Matilda H. Theiss Health Center· Pittsburgh, PA

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