건강 통합 영양 및 신장 웰니스 프로그램의 실행 가능성 (THINK-Well)

실험적: THINK-Well

신장 질환을 가진 사람들과의 하이브리드(대면 및 가상) 실용적 영양 교육. 그룹 세션을 통해 신장 질환을 가진 다른 사람들로부터 사회적 지원을 받고, 목표 설정과 개인 맞춤형 문제 해결을 용이하게 하며, 여러 건강 상태를 가진 사람들을 위한 통합적 영양 접근법을 논의하고, 기본적인 요리 기술을 개발하면서 전식품 중심의 심장 건강에 좋은 식단을 장려할 것입니다. 참가자들은 또한 농산물 구매를 위한 재정적 지원을 받고 1:1 영양 상담을 선택적으로 거부할 수 있습니다.

행동: THINK-Well

Seven hybrid (online or in-person) group nutrition education sessions paired with food bucks and one individual consultation with a dietitian over 12-20 weeks.

활성 비교기: Enhanced Usual Care

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

다른: 향상된 일상적 치료

훈련된 교육자가 제공하는 두 차례의 가상 그룹 영양 교육 세션.

모집의 실현 가능성

모집 가능성은 선별, 적격성 및 등록 지표를 사용하여 평가됩니다. 연구 적격성을 위해 선별된 환자의 총 수가 기록됩니다. 적격성 비율은 연구 적격 기준을 충족하는 환자 수를 선별된 환자 총 수로 나눈 값으로 계산됩니다. 등록률은 등록된 환자 수를 적격 환자 수로 나눈 값으로 계산되며 월별 백분율로 표시됩니다.

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

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.

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.

체성분 변화 (체지방률)

체성분은 체성분 분석기를 사용한 생체 전기 임피던스 분석(BIA)으로 평가됩니다. BIA는 체조직을 통한 전기적 임피던스를 측정하고 참가자 특성(예: 연령, 성별, 키, 체중)을 예측 방정식에 포함하여 체성분을 추정합니다.

다음 체성분 측정값은 BIA를 통해 측정 및 획득됩니다:

체지방률(%): 전체 체중 중 지방 조직이 차지하는 비율로, 0-100% 범위의 백분율로 표현됩니다.

근육량 비율(%): 전체 체중 중 근육 조직이 차지하는 비율로, 0-100% 범위의 백분율로 표현됩니다.

체지방률 감소와 근육량 비율 증가는 체성분 개선을 나타냅니다.

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.

Interpretation of the composite score usually follows these general categories:

0-49: Low cardiovascular health 50-79: Moderate cardiovascular health 80-100: High (optimal) cardiovascular health

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.

The scale includes 6 items, each rated on a 10-point numeric scale ranging from 1 ("not at all confident") to 10 ("totally confident").

Scores are calculated as the mean of the six items, producing a final score ranging from 1 to 10.

Higher scores indicate greater confidence in the ability to manage chronic disease-related health challenges.

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.

The PAM-13 consists of 13 statements rated on a 4-point Likert scale (strongly disagree to strongly agree) with an additional "not applicable" option.

Responses are summed and converted using a proprietary scoring algorithm to a standardized activation score ranging from 0 to 100.

Higher scores indicate greater patient activation.

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.

The instrument contains five subscales:

1. Symptoms and Problems of Kidney Disease (12 items)
2. Effects of Kidney Disease on Daily Life (8 items)
3. Burden of Kidney Disease (4 items)
4. Physical Component Summary (PCS) derived from the Short Form-12
5. Mental Component Summary (MCS) derived from the Short Form-12

Each 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/burdens. The KDQOL-36 does not produce a single total score; results are reported for each subscale.

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.

The 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.

Each 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.

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).

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.

Body mass index (BMI) (kg/m²): BMI will be calculated as weight in kilograms divided by reported height in meters squared.

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).

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.

The following body composition measures will be collected:

Fat mass (kg): Estimated total body fat mass measured in kilograms.

Reductions in fat mass represent improvements in body composition.

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.

The following body composition measures will be collected:

Muscle mass (kg): Estimated total skeletal muscle mass measured in kilograms.

Increases in muscle mass represent improvements in body composition.

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.

The 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).

Increases in muscle mass and percent muscle mass represent improvements in body composition.