Feasibility of The Health Integrated Nutrition and Kidney Wellness Program

Официальное название

The Health Integrated, Nutrition and Kidney-Wellness (THINK-Well) Program- Phase 2

Обзор

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 finish the full 12-week program? 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 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 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.

Вмешательства

• Поведенческое 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.
• Другое Enhanced Usual Care
  Two virtual group nutrition educational sessions provided by a trained educator.

Первичные конечные точки

• Feasibility of Recruitment [Срок оценки: During the study recruitment period (anticipated up to 6 months)]
• Participant retention [Срок оценки: Baseline to end of the 12-week intervention]
• Intervention adherence [Срок оценки: During the 12-week intervention period]
• Participant satisfaction [Срок оценки: End of the 12-week intervention period]

Вторичные конечные точки (12)

• Change from Baseline in Life's Essential 8 score at 12-weeks [Срок оценки: From baseline to end of 12-week intervention]
• Change from Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) at 12-weeks [Срок оценки: From baseline to end of 12-week intervention]
• Change from Baseline Patient Activation Measure, 13-item version (PAM-13) at 12-weeks [Срок оценки: From baseline to end of 12-week intervention]
• Change from Baseline Kidney Disease Quality of Life - 36 at 12-weeks [Срок оценки: From baseline to end of 12-weeks intervention]
• Change from Baseline in Mediterranean Diet adherence at 12-weeks [Срок оценки: From baseline to end of 12-week intervention]
• Change from baseline in Body Composition at 12-weeks [Срок оценки: Baseline to after 12-weeks]
• Change in Body Mass Index (BMI) [Срок оценки: From baseline to the end of the 12-week intervention.]
• Change in Waist-to-Hip Ratio [Срок оценки: From baseline to the end of the 12-week intervention]
• Change in Body Composition (Fat Mass) [Срок оценки: Change from baseline to the end of the 12 week intervention]
• Change in Body Composition (Muscle Mass) [Срок оценки: Change from baseline to the end of 12-week intervention]
• Change in Body Composition (Percent Body Fat) [Срок оценки: Change from baseline to the end of the 12 week intervention]
• Change in Body Composition (Percent Muscle Mass) [Срок оценки: Change from baseline to the end of the 12 week intervention]

Критерии участия

Критерии включения

• 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 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.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 5 центров

• UPMC Kidney Clinic - Wexford — Pittsburgh
• UPMC Kidney Clinic - Monroeville — Pittsburgh
• UPMC Kidney Clinic - Oakland — Pittsburgh
• UPMC Matilda H. Theiss Health Center — Pittsburgh
• UPMC Kidney Clinic - Shadyside — Pittsburgh

Идентификаторы

NCT: NCT07518719 · STUDY25050072

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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