Recruiting

THINK-Well Intervention

Sponsor:

University of Pittsburgh

Code:

NCT07518719

Conditions

Chronic Kidney Disease

Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

THINK-Well

Enhanced Usual Care

Study Details

Brief summary:

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.

Conditions

Chronic Kidney Disease

Cardiovascular Disease

Study ID

NCT07518719

Start date

Apr 24, 2026

Status verified date

May, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

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-weeks.

Enhanced Usual Care

Two virtual group nutrition educational sessions provided by a trained educator.

Primary outcome measure

  • Feasibility of Recruitment [ Time Frame: During the study recruitment period (anticipated up to 6 months) ]
  • Participant retention [ Time Frame: Baseline to end of the 12-week intervention ]
  • Intervention adherence [ Time Frame: During the 12-week intervention period ]
  • Participant satisfaction [ Time Frame: End of the 12-week intervention period ]

Central Contacts and Locations

Central contacts

Linda-Marie Lavenburg, DO, MS

12679807722lavenburglu@upmc.edu

Manisha Jhamb, MD, MPH

412-647-7062jhambm@upmc.edu

Locations

UPMC Kidney Clinic - Wexford

Recruiting

Pittsburgh, Pennsylvania, United States, 15090

Contacts

Linda-Marie Lavenburg, DO

412-663-5528lavenburglu@upmc.edu

UPMC Kidney Clinic - Monroeville

Recruiting

Pittsburgh, Pennsylvania, United States, 15146

Contacts

Christopher Passero, MD

412-578-9551passerocj@upmc.edu

UPMC Kidney Clinic - Oakland

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jyotsana Thakkar, MD

412-756-3228thakkarj@upmc.edu

UPMC Kidney Clinic - Shadyside

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Christopher Passero, MD

412-578-9551passerocj@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • lifestyle intervention
  • community partnered
  • nutrition
  • culinary medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-06-01.