[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07518719":3,"trial-entities:NCT07518719":179,"trial-summary:NCT07518719":186},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":14,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":42,"secondary_outcomes":59,"sex":103,"minimum_age":104,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":105,"std_ages":112,"locations":115,"central_contacts":165,"overall_officials":173,"references":177,"see_also_links":178},"NCT07518719","STUDY25050072","Feasibility of The Health Integrated Nutrition and Kidney Wellness Program","The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program- Phase 2","RECRUITING","2026-10","2026-05","2026-06-01","2026-04-24","University of Pittsburgh","OTHER",false,"Purpose of the Study:\n\nThis 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.\n\nMain Questions:\n\nHow many eligible patients choose to join the program?\n\nHow many participants finish the full 12-week program?\n\nHow satisfied are participants with the program?\n\nWhat Participants Will Do:\n\nParticipants will be assigned to a diet-focused lifestyle education series (THINK-Well Intervention) or enhance usual care.\n\nTHINK-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.\n\nThe 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.",null,[19,20],"Chronic Kidney Disease","Cardiovascular Disease",[22,23,24,25],"lifestyle intervention","community partnered","nutrition","culinary medicine","INTERVENTIONAL",[28],"NA",{"count":30,"type":31},45,"ESTIMATED",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","THINK-Well","Seven hybrid (online or in-person) group nutrition education sessions paired with food bucks and one individual consultation with a dietitian over 12-weeks.",[35],{"type":14,"name":39,"description":40,"armGroupLabels":41},"Enhanced Usual Care","Two virtual group nutrition educational sessions provided by a trained educator.",[39],[43,47,51,55],{"measure":44,"description":45,"timeFrame":46},"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)",{"measure":48,"description":49,"timeFrame":50},"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","Baseline to end of the 12-week intervention",{"measure":52,"description":53,"timeFrame":54},"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.","During the 12-week intervention period",{"measure":56,"description":57,"timeFrame":58},"Participant satisfaction","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.","End of the 12-week intervention period",[60,64,67,70,74,77,81,85,89,93,97,100],{"measure":61,"description":62,"timeFrame":63},"Change from Baseline in Life's Essential 8 score at 12-weeks","Life's Essential 8 score is a composite cardiovascular health (CVH) score developed by the American Heart Association (AHA) to quantify and track an individual's heart- and brain-health based on eight key lifestyle behaviors and clinical health factors (healthy diet, physical activity, nicotine exposure, sleep health, body mass index, lipids, glucose and blood pressure). The score ranges from 0 to 100 points, with higher scores indicating better overall cardiovascular health.\n\nInterpretation of the composite score usually follows these general categories:\n\n0-49: Low cardiovascular health 50-79: Moderate cardiovascular health 80-100: High (optimal) cardiovascular health","From baseline to end of 12-week intervention",{"measure":65,"description":66,"timeFrame":63},"Change from Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) at 12-weeks","Self-efficacy will be assessed using the Chronic Disease Self-Efficacy Scale (Self-Efficacy for Managing Chronic Disease 6-Item Scale). This instrument measures an individual's confidence in their ability to manage symptoms, fatigue, emotional distress, and health tasks associated with chronic disease.\n\nThe scale includes 6 items, each rated on a 10-point numeric scale ranging from 1 (\"not at all confident\") to 10 (\"totally confident\").\n\nScores are calculated as the mean of the six items, producing a final score ranging from 1 to 10.\n\nHigher scores indicate greater confidence in the ability to manage chronic disease-related health challenges.",{"measure":68,"description":69,"timeFrame":63},"Change from Baseline Patient Activation Measure, 13-item version (PAM-13) at 12-weeks","Patient activation will be measured using the Patient Activation Measure-13 (PAM-13), which assesses an individual's knowledge, skills, and confidence in managing their health and healthcare.\n\nThe PAM-13 consists of 13 statements rated on a 4-point Likert scale (strongly disagree to strongly agree) with an additional \"not applicable\" option.\n\nResponses are summed and converted using a proprietary scoring algorithm to a standardized activation score ranging from 0 to 100.\n\nHigher scores indicate greater patient activation.",{"measure":71,"description":72,"timeFrame":73},"Change from Baseline Kidney Disease Quality of Life - 36 at 12-weeks","KDQOL is a kidney disease-specific quality-of-life instrument that combines a generic core with targeted modules to measure how CKD and its treatments impact patients' well-being across physical, emotional, and social dimensions.\n\nThe instrument contains five subscales:\n\n1. Symptoms and Problems of Kidney Disease (12 items)\n2. Effects of Kidney Disease on Daily Life (8 items)\n3. Burden of Kidney Disease (4 items)\n4. Physical Component Summary (PCS) derived from the Short Form-12\n5. Mental Component Summary (MCS) derived from the Short Form-12\n\nEach subscale is scored on a 0-100 scale after standard scoring transformation according to KDQOL-36 scoring guidelines. Higher scores indicate better quality of life or fewer symptoms\u002Fburdens. The KDQOL-36 does not produce a single total score; results are reported for each subscale.","From baseline to end of 12-weeks intervention",{"measure":75,"description":76,"timeFrame":63},"Change from Baseline in Mediterranean Diet adherence at 12-weeks","Diet quality will be assessed using the Mediterranean Eating Pattern for Americans (MEPA) tool, which is an instrument developed to assess how closely a person's diet aligns with the Mediterranean dietary pattern adapted for U.S. populations. Total scores are summed to produce a composite Mediterranean diet adherence score. Higher scores indicate closer alignment with the Mediterranean Eating Pattern.\n\nThe screener consists of 16 items assessing frequency or quantity of consumption of key Mediterranean diet components including fruits, vegetables, whole grains, legumes, nuts, fish, olive oil, and red or processed meats.\n\nEach item contributes 0 or 1 point based on whether the recommended intake threshold is met. Scores are summed to produce a total score ranging from 0 to 16.",{"measure":78,"description":79,"timeFrame":80},"Change from baseline in Body Composition at 12-weeks","Using a bioimpedence scale, we will measure and collect body composition data. This will include: Fat Mass (measured in kilograms), Muscle Mass (measured in kilograms), Percent Fat Mass (measured as a percentage), and Percent Muscle Mass (measured as a percentage).","Baseline to after 12-weeks",{"measure":82,"description":83,"timeFrame":84},"Change in Body Mass Index (BMI)","Body Mass Index (BMI) will be calculated from two anthropometric measures, body weight and reported height. These two measures will be collected using standardized measurement procedures. The following measures will be assessed: Body weight (kg): Body weight will be measured in kilograms using a calibrated digital scale with participants wearing light clothing and no shoes. Reported height will be taken from an average of the patient's three most recent electronic medical record heights.\n\nBody mass index (BMI) (kg\u002Fm²): BMI will be calculated as weight in kilograms divided by reported height in meters squared.","From baseline to the end of the 12-week intervention.",{"measure":86,"description":87,"timeFrame":88},"Change in Waist-to-Hip Ratio","Waist-to-hip ratio measures will be collected using standardized measurement procedures and measured in centimeters. Waist circumference and hip circumference will be measured in centimeters using a flexible measuring tape. Waist circumference will be measured at the midpoint between the lower rib and the iliac crest. Hip circumference will be measured at the widest portion of the buttocks. Waist-to-hip ratio will be calculated as waist circumference (cm) divided by hip circumference (cm).","From baseline to the end of the 12-week intervention",{"measure":90,"description":91,"timeFrame":92},"Change in Body Composition (Fat Mass)","Body composition will be assessed using bioelectrical impedance analysis (BIA) with a body composition analyzer. BIA estimates body composition by measuring electrical impedance through body tissues and incorporating participant characteristics (e.g., age, sex, height, and weight) into prediction equations.\n\nThe following body composition measures will be collected:\n\nFat mass (kg): Estimated total body fat mass measured in kilograms.\n\nReductions in fat mass represent improvements in body composition.","Change from baseline to the end of the 12 week intervention",{"measure":94,"description":95,"timeFrame":96},"Change in Body Composition (Muscle Mass)","Body composition will be assessed using bioelectrical impedance analysis (BIA) with a body composition analyzer. BIA estimates body composition by measuring electrical impedance through body tissues and incorporating participant characteristics (e.g., age, sex, height, and weight) into prediction equations.\n\nThe following body composition measures will be collected:\n\nMuscle mass (kg): Estimated total skeletal muscle mass measured in kilograms.\n\nIncreases in muscle mass represent improvements in body composition.","Change from baseline to the end of 12-week intervention",{"measure":98,"description":99,"timeFrame":92},"Change in Body Composition (Percent Body Fat)","Body composition will be assessed using bioelectrical impedance analysis (BIA) with a body composition analyzer. BIA estimates body composition by measuring electrical impedance through body tissues and incorporating participant characteristics (e.g., age, sex, height, and weight) into prediction equations.\n\nThe following body composition measures will be measured and obtained from BIA:\n\nPercent body fat (%): The proportion of total body weight composed of fat tissue, expressed as a percentage ranging from 0-100%.\n\nPercent muscle mass (%): The proportion of total body weight composed of fat tissue, expressed as a percentage ranging from 0-100%.\n\nReductions in percent body fat and increase in percent muscle mass represent improvements in body composition.",{"measure":101,"description":102,"timeFrame":92},"Change in Body Composition (Percent Muscle Mass)","Body composition will be assessed using bioelectrical impedance analysis (BIA) with a body composition analyzer. BIA estimates body composition by measuring electrical impedance through body tissues and incorporating participant characteristics (e.g., age, sex, height, and weight) into prediction equations.\n\nThe following body composition measures will be calculated: Percent muscle mass (%): The proportion of total body weight composed of skeletal muscle tissue, expressed as a percentage ranging from 0-100%. Percent Muscle Mass will be calculated from two collected measures: Body Mass (kg), and Muscle Mass (kg).\n\nIncreases in muscle mass and percent muscle mass represent improvements in body composition.","ALL","18 Years",{"inclusion":106,"exclusion":108,"raw_text":111},[107],"Adult (age ≥ 18 years) patients of UPMC Clinic and the presence of non-dialysis CKD defined by lab values (eGFR ≤ 60 ml\u002Fmin\u002F1.73m2) and at least one of the following: uncontrolled diabetes (HbA1c ≥ 7.5%), hypertension (12-month average blood pressure ≥130\u002F80 mmHg), overweight or obese body mass index, or positive screening for food insecurity.",[109,110],"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.","Inclusion Criteria:\n\n* Adult (age ≥ 18 years) patients of UPMC Clinic and the presence of non-dialysis CKD defined by lab values (eGFR ≤ 60 ml\u002Fmin\u002F1.73m2) and at least one of the following: uncontrolled diabetes (HbA1c ≥ 7.5%), hypertension (12-month average blood pressure ≥130\u002F80 mmHg), overweight or obese body mass index, or positive screening for food insecurity.\n* 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.\n\nExclusion Criteria:\n\n* To minimize attrition, individuals on dialysis, or planned to start dialysis or receive kidney transplant in the next 6 months will be excluded.\n* 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.",[113,114],"ADULT","OLDER_ADULT",[116,131,140,149,159],{"facility":117,"status":8,"city":118,"state":119,"zip":120,"country":121,"contacts":122,"geoPoint":128},"UPMC Kidney Clinic - Wexford","Pittsburgh","Pennsylvania","15090","United States",[123],{"name":124,"role":125,"phone":126,"email":127},"Linda-Marie Lavenburg, DO","CONTACT","412-663-5528","lavenburglu@upmc.edu",{"lat":129,"lon":130},40.44062,-79.99589,{"facility":132,"status":8,"city":118,"state":119,"zip":133,"country":121,"contacts":134,"geoPoint":139},"UPMC Kidney Clinic - Monroeville","15146",[135],{"name":136,"role":125,"phone":137,"email":138},"Christopher Passero, MD","412-578-9551","passerocj@upmc.edu",{"lat":129,"lon":130},{"facility":141,"status":8,"city":118,"state":119,"zip":142,"country":121,"contacts":143,"geoPoint":148},"UPMC Kidney Clinic - Oakland","15213",[144],{"name":145,"role":125,"phone":146,"email":147},"Jyotsana Thakkar, MD","412-756-3228","thakkarj@upmc.edu",{"lat":129,"lon":130},{"facility":150,"status":151,"city":118,"state":119,"zip":152,"country":121,"contacts":153,"geoPoint":158},"UPMC Matilda H. Theiss Health Center","NOT_YET_RECRUITING","15219",[154],{"name":155,"role":125,"phone":156,"email":157},"Mylynda Massart, MD, PhD","412-647-9304","massartmb@upmc.edu",{"lat":129,"lon":130},{"facility":160,"status":8,"city":118,"state":119,"zip":161,"country":121,"contacts":162,"geoPoint":164},"UPMC Kidney Clinic - Shadyside","15232",[163],{"name":136,"role":125,"phone":137,"email":138},{"lat":129,"lon":130},[166,169],{"name":167,"role":125,"phone":168,"email":127},"Linda-Marie Lavenburg, DO, MS","12679807722",{"name":170,"role":125,"phone":171,"email":172},"Manisha Jhamb, MD, MPH","412-647-7062","jhambm@upmc.edu",[174],{"name":175,"affiliation":13,"role":176},"Linda-Marie U Lavenburg, DO, MS","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":180,"biomarkers":185},[19,181,182,183,184],"Diabetes Mellitus","Food Insecurity","Hypertension","Obesity",[],{"nct_id":4,"found":187,"summary":188,"prompt_version":197},true,{"design":189,"status":190,"heading":6,"summary":191,"follow_up":192,"word_count":193,"commitments":194,"compensation":195,"drugs_mentioned":196},"This interventional study plans to enroll 45 participants. It is designed to see if a new nutrition program is practical and well-received.","completed","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\u002Fmin\u002F1.73m2) and have conditions like uncontrolled diabetes, high blood pressure, or food insecurity.","Participant retention and intervention adherence will be measured during the 12-week intervention period.",117,"You would participate in either seven hybrid group nutrition education sessions and one individual consultation over 12 weeks, or two virtual group nutrition sessions.","Not stated in the trial record.",[35,39],"v2"]