45 Participants NeededMy employer runs this trial

THINK-Well Program for Chronic Kidney Disease

(THINK-Well Trial)

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?

This trial tests a new nutrition and kidney health program to determine its effectiveness for adults with chronic kidney disease. Participants will either join a 12-week series of group sessions focused on diet and lifestyle changes (THINK-Well Intervention) or receive standard nutrition education (Enhanced Usual Care). The trial aims to assess participation rates, completion rates, and participant satisfaction. It suits adults with kidney disease not requiring dialysis, who may also face challenges like uncontrolled diabetes, high blood pressure, being overweight, or food insecurity. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance kidney health and nutrition strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on nutrition and lifestyle changes, so you may not need to change your medications, but it's best to ask the trial coordinators for confirmation.

What prior data suggests that the THINK-Well Program is safe for adults with kidney disease?

Research has shown that lifestyle programs like the THINK-Well Program can be safe and beneficial for people with chronic kidney disease (CKD). Studies have found that these programs improve health and help patients manage their condition more effectively. The THINK-Well Program, which focuses on nutrition and kidney health, was developed with input from both patients and experts to ensure it meets participants' needs.

The available data reports no serious side effects, suggesting the program is well-tolerated. Participants learn practical skills such as meal preparation and receive support from others with similar health conditions, which can enhance their well-being. Overall, evidence supports the THINK-Well Program as a safe choice for those seeking to improve their health while managing CKD.12345

Why are researchers excited about this trial?

Researchers are excited about the THINK-Well Program because it offers a fresh approach to managing chronic kidney disease by combining practical nutrition education with social support. Unlike standard care that typically involves medication and basic dietary advice, THINK-Well provides a hybrid of in-person and virtual sessions that engage participants in goal-setting, problem-solving, and culinary skill development. This program not only educates individuals about a whole-food, heart-healthy diet but also supports them financially to make healthier food choices, potentially improving their overall quality of life.

What evidence suggests that the THINK-Well Intervention could be effective for chronic kidney disease?

Research has shown that nutrition-focused programs can help people with chronic kidney disease (CKD) improve their health. This trial will compare the THINK-Well Intervention, which includes hybrid practical nutrition education and support, with Enhanced Usual Care, which involves virtual nutrition education sessions. Previous studies have found that similar programs help people take better care of themselves and feel better overall. For instance, a digital health program helped CKD patients manage their blood sugar levels. Another study showed that people gained more health knowledge after participating in nutrition sessions led by peers. These findings suggest that structured nutritional education and support can effectively help manage CKD.14678

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?

This trial is for adults with chronic kidney disease (not on dialysis) who get care at UPMC Clinic. They must also have uncontrolled diabetes, high blood pressure, be overweight/obese, or have trouble affording food. Participants should be ready to make lifestyle changes and not planning to start dialysis or get a kidney transplant soon.

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

Trial Overview

The study compares a 12-week nutrition and wellness program (THINK-Well), which includes group sessions and cooking classes, against enhanced usual care with two virtual nutrition education sessions. The goal is to see if the new program works well for people with kidney disease.

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33866968/

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