Feasibility of The Health Integrated Nutrition and Kidney Wellness Program

NCT07518719 | Recruiting

• 1 other identifier: STUDY25050072
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

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 complete all 7 educational sessions? 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 12-20 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 12-20 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

Keywords

lifestyle intervention; community partnered; nutrition; culinary medicine

Outcome Measures

Primary Outcomes (4)

• Feasibility of Recruitment

  Recruitment feasibility will be assessed using screening, eligibility, and enrollment metrics. The total number of patients screened for study eligibility will be recorded. The eligibility rate will be calculated as the number of patients who meet study eligibility criteria divided by the total number of patients screened. The enrollment rate will be calculated as the number of patients enrolled divided by the number of eligible patients and expressed as a percentage per month.

  During the study recruitment period (anticipated up to 6 months)

• Participant retention

  Retention will be assessed as the proportion of enrolled participants who complete the 12-week THINK-Well program and the end-of-study assessment. Retention rate will be calculated as the number of participants who complete the final study assessment divided by the total number of participants enrolled, expressed as a percentage. Monthly dropout rate and reason for dropout

  From baseline to end of the intervention period (12-20 weeks)

• Intervention adherence

  Intervention adherence will be assessed by participant attendance at scheduled program sessions. Adherence will be calculated as the number of sessions attended divided by the total number of planned sessions for each participant and summarized as the mean percentage of sessions attended across participants.

  From baseline to end of the intervention period (12-20 weeks)

• Participant satisfaction

  Participant satisfaction with the THINK-Well program will be assessed using a post-intervention questionnaire administered at the end of the intervention. The survey will assess participants' perceptions of the usefulness, relevance, and overall satisfaction with the program content, delivery format (virtual and in-person sessions), and program activities. Satisfaction will be summarized using descriptive statistics, including mean scores and the proportion of participants reporting high satisfaction.

  From baseline to end of the intervention period (12-20 weeks)

Secondary Outcomes (12)

• Change from Baseline in Life's Essential 8 score at 12-weeks

  From baseline to end of the intervention period (12-20 weeks)

• Change from Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) at 12-weeks

  From baseline to end of the intervention period (12-20 weeks)

• Change from Baseline Patient Activation Measure, 13-item version (PAM-13) at 12-weeks

  From baseline to end of the intervention period (12-20 weeks)

• Change from Baseline Kidney Disease Quality of Life - 36 at 12-weeks

  From baseline to end of the intervention period (12-20 weeks)

• Change from Baseline in Mediterranean Diet adherence at 12-weeks

  From baseline to end of the intervention period (12-20 weeks)

Study Arms (2)

THINK-Well

EXPERIMENTAL

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.

Behavioral: THINK-Well

Enhanced Usual Care

ACTIVE COMPARATOR

The enhanced usual care group will receive two virtual nutrition education sessions led by a trained educator over 12-20 weeks.

Other: Enhanced Usual Care

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 12-20 weeks.

THINK-Well

Enhanced Usual Care OTHER

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

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 any level of proteinuria (or albuminuria); or eGFR \> 60 and urine-protein-to-creatinine ratio or urine-albumin-to-creatinine ratio \> 30mg/g), 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.

You may not qualify if:

• 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.
• We are excluding participants who have no electronic health record data within the last 18 months. Specifically, no office visits, kidney function labs (i.e.. eGFR, uACR, and uPCR values), or documentation of CKD (stage 3 or higher) or proteinuria. We believe that patients without this data will be less likely to have the necessary lab data we are collecting for the pre- and post- intervention periods.

Sponsors & Collaborators

• University of Pittsburgh: lead
• American Heart Association: collaborator

Study Sites (5)

UPMC Kidney Clinic - Wexford

Pittsburgh, Pennsylvania, 15090, United States

RECRUITING

UPMC Kidney Clinic - Monroeville

Pittsburgh, Pennsylvania, 15146, United States

RECRUITING

UPMC Kidney Clinic - Oakland

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC Matilda H. Theiss Health Center

Pittsburgh, Pennsylvania, 15219, United States

NOT YET RECRUITING

UPMC Kidney Clinic - Shadyside

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda-Marie U Lavenburg, DO, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda-Marie Lavenburg, DO, MS

CONTACT

12679807722; lavenburglu@upmc.edu

Manisha Jhamb, MD, MPH

CONTACT

412-647-7062; jhambm@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: April 24, 2026
• Primary Completion: October 1, 2026
• Study Completion: October 1, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified IPD will be made available upon study completion. Supporting information will be available at the trial end. The data will be retained for at least 7 years in accordance with the University of Pittsburgh's data retention policy.
• Access Criteria: Insignia Health will have access to de-identified IPD and the supporting information. They will be able to access a dataset including PAM scores and supporting demographic, self-reported, or clinical data.

Locations

US (5)