THINK-Well Program for Chronic Kidney Disease

(THINK-Well Trial)

Not yet recruiting at 4 trial locations
LL
MJ
Overseen ByManisha Jhamb, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

LU

Linda-Marie U Lavenburg, DO, MS

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Inclusion Criteria

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
I am an adult with non-dialysis kidney disease and at least one related health issue.

Exclusion Criteria

Excludes those in pre-contemplative stage of change due to low commitment potentially interfering with the primary goal to measure feasibility.
I am on dialysis or will start dialysis or get a kidney transplant soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 months

Treatment

Participants are assigned to either the THINK-Well Intervention or Enhanced Usual Care group for a 12-week program.

12 weeks
7 group sessions (THINK-Well), 2 virtual sessions (Enhanced Usual Care)

Follow-up

Participants are monitored for retention, adherence, and satisfaction with the program.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced Usual Care
  • THINK-Well Intervention

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: THINK-WellExperimental Treatment1 Intervention
Group II: Enhanced Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

American Heart Association

Collaborator

Trials
352
Recruited
6,196,000+