Feasibility of The Health Integrated Nutrition and Kidney Wellness Program
This study is testing a nutrition and kidney health program called THINK-Well for adults with chronic kidney disease (CKD) and cardiovascular disease. The program involves seven group nutrition education sessions, either online or in-person, along with food bucks and a one-on-one meeting with a dietitian over 12 weeks. You might also be assigned to an "Enhanced Usual Care" group, which includes two virtual group nutrition sessions. The study wants to see how many people join, how many finish the 12-week program, and how satisfied participants are. To join, you need to be an adult patient at UPMC Clinic with non-dialysis CKD (eGFR ≤ 60 ml/min/1.73m2) and have conditions like uncontrolled diabetes, high blood pressure, or food insecurity.
- Study design
- This interventional study plans to enroll 45 participants. It is designed to see if a new nutrition program is practical and well-received.
- What's involved
- You would participate in either seven hybrid group nutrition education sessions and one individual consultation over 12 weeks, or two virtual group nutrition sessions.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participant retention and intervention adherence will be measured during the 12-week intervention period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Feasibility of The Health Integrated Nutrition and Kidney Wellness Program
At a glance
Conditions
Where it's being run
5 sites across 1 statesStudy leadership
- Linda-Marie U Lavenburg, DO, MS · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Feasibility of RecruitmentDuring the study recruitment period (anticipated up to 6 months)
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.
- Participant retentionBaseline to end of the 12-week intervention
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
- Intervention adherenceDuring the 12-week intervention period
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.
- Participant satisfactionEnd of the 12-week intervention period
Participant satisfaction with the THINK-Well program will be assessed using a post-intervention questionnaire administered at the end of the 12-week program. 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.