統合的健康栄養および腎臓ウェルネスプログラムの実現可能性 (THINK-Well)

実験的：THINK-Well

腎臓病患者を対象とした、対面とバーチャルのハイブリッド形式による実践的な栄養教育。 グループセッションでは、他の腎臓病患者からの社会的支援が得られ、目標設定と個別の問題解決が促進され、複数の健康状態を持つ人々のための統合的な栄養アプローチについて議論し、ホールフードで心臓に優しい食事を奨励しながら基本的な調理技術を身につけます。 参加者は、農産物を購入するための経済的支援も受けられ、1対1の栄養カウンセリングをオプトアウトすることもできます。

行動：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.

アクティブコンパレータ：Enhanced Usual Care

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

他の：強化された通常ケア

訓練を受けた教育者による2回の仮想グループ栄養教育セッション。

募集の実現可能性

募集の実現可能性は、スクリーニング、適格性、および登録の指標を使用して評価されます。 研究適格性のためにスクリーニングされた患者の総数が記録されます。 適格率は、研究適格基準を満たす患者数をスクリーニングされた患者の総数で割って計算されます。 登録率は、登録された患者数を適格患者数で割り、月ごとのパーセンテージとして表して計算されます。

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.

体組成の変化（体脂肪率）

体組成は、体組成分析装置を用いた生体電気インピーダンス分析（BIA）により評価されます。 BIAは、身体組織を通る電気インピーダンスを測定し、参加者の特性（年齢、性別、身長、体重など）を予測式に組み込むことで体組成を推定します。

以下の体組成測定値がBIAから測定・取得されます：

体脂肪率（％）：脂肪組織で構成される全体重の割合で、0～100％の範囲で表されます。

筋肉量率（％）：脂肪組織で構成される全体重の割合で、0～100％の範囲で表されます。

体脂肪率の減少と筋肉量率の増加は、体組成の改善を示します。

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.