THINK-Well Program for Chronic Kidney Disease
(THINK-Well Trial)
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are assigned to either the THINK-Well Intervention or Enhanced Usual Care group for a 12-week program.
Follow-up
Participants are monitored for retention, adherence, and satisfaction with the program.
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
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.
The enhanced usual care group will receive two virtual nutrition education sessions led by a trained educator over 12-20 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
American Heart Association
Collaborator
Citations
Effectiveness of Wellbeing Intervention for Chronic Kidney ...
This three-arm, waitlist, single-blind randomised controlled trial examined efficacy of the Stay Strong App in improving psychological distress.
Effectiveness of Wellbeing Intervention for Chronic Kidney ...
This three-arm, waitlist, single-blind randomised controlled trial examined efficacy of the Stay Strong App in improving psychological distress.
Protocol # (STUDY 25050072) The Health Integrated, ...
This study is not powered to establish the efficacy of THINK-Well Program on clinical (secondary) outcomes. However, we will administer ...
Measuring Health-Related Outcomes After a Peer-Led ...
Data from 54 African-American patients indicated statistically significant improvement in scores on the Health Knowledge. Scale, but no change in healthy ...
Exploring How the Kidney BEAM Physical Activity Digital ...
The Kidney BEAM intervention was shown to have mental and physical wellbeing benefits and enhanced self-management in this cohort of people living with chronic ...
Supporting people with chronic kidney disease to self-manage ...
Self-management has been identified as an essential component in the effective management of patients with chronic kidney disease (CKD).
Lifestyle Interventions in Improving Health Outcomes and ...
Lifestyle interventions can play an important role in improving patients' health outcomes and helping them to live well with chronic kidney disease (CKD).
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stocktitan.net
stocktitan.net/news/AKBA/akebia-therapeutics-announces-vadadustat-post-hoc-win-statistics-ua1g7mw4wete.htmlAkebia JASN paper: vadadustat improves CKD composite
The analysis found a statistically significant improvement for vadadustat versus darbepoetin alfa on a hierarchical composite of all‑cause ...
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