PDF(Pubmed)
Abstract：
Digital health tools can support behavior change and allow interventions to be scalable at a minimal cost. Keep-on-Keep-up Nutrition (KOKU-Nut) is a free, tablet-based app that focuses on increasing physical activity and improving the dietary intake of older adults based on UK guidelines. The intervention targets an important research area identified as a research priority reported by the James Lind Alliance priority setting partnership for malnutrition.
This study aims to assess the feasibility of using the digital health tool KOKU-Nut among community-dwelling older adults to inform a future randomized controlled trial. The secondary aims are to determine the acceptability, usability, preliminary effect sizes, and safety of the study and the intervention (KOKU-Nut).
This is a feasibility randomized controlled trial. We plan to recruit a total of 36 community-dwelling older adults using purposive sampling. Participants will be randomized 1:1 to either the intervention or the control group. The intervention group will be asked to engage with KOKU-Nut 3 times a week for 12 weeks. Participants in the control group will receive a leaflet promoting a healthy lifestyle. All study participants will complete questionnaires at baseline and the end of the 12 weeks. A sample of participants will be asked to participate in an optional interview. The study will collect a range of data including anthropometry (height and weight), dietary intake (3-day food diary), physical function (grip strength and 5-times sit-to-stand), perceived quality of life (EQ-5D), usability (System Usability Scale), and safety (adverse events).
Data collection commenced in March 2024, and the results will be ready for publication by January 2025. Feasibility will be determined on the basis of participants\' self-reported engagement with the intervention, and recruitment and retention rates and will be summarized descriptively. We will also consider the amount of missing data and assess how outcomes are related to group assignment. Acceptability will be measured using the modified treatment evaluation inventory and one-to-one semistructured interviews. Transcripts from the interviews will be analyzed using NVivo (version 12; QSR International) software using framework analysis to understand any barriers to the recruitment process, the suitability of the assessment measures, and the acceptability of the intervention and study design.
The study aligns with guidelines developed by the Medical Research Council for developing a complex intervention by using qualitative and quantitative research to examine the barriers of the intervention and identify potential challenges around recruitment and retention. We anticipate that these results will inform the development of a future powered randomized controlled design trial to test the true effectiveness of KOKU-Nut.
ClinicalTrials.gov NCT05943366; https://classic.clinicaltrials.gov/ct2/show/NCT05943366.
PRR1-10.2196/50922.
This study aims to assess the feasibility of using the digital health tool KOKU-Nut among community-dwelling older adults to inform a future randomized controlled trial. The secondary aims are to determine the acceptability, usability, preliminary effect sizes, and safety of the study and the intervention (KOKU-Nut).
This is a feasibility randomized controlled trial. We plan to recruit a total of 36 community-dwelling older adults using purposive sampling. Participants will be randomized 1:1 to either the intervention or the control group. The intervention group will be asked to engage with KOKU-Nut 3 times a week for 12 weeks. Participants in the control group will receive a leaflet promoting a healthy lifestyle. All study participants will complete questionnaires at baseline and the end of the 12 weeks. A sample of participants will be asked to participate in an optional interview. The study will collect a range of data including anthropometry (height and weight), dietary intake (3-day food diary), physical function (grip strength and 5-times sit-to-stand), perceived quality of life (EQ-5D), usability (System Usability Scale), and safety (adverse events).
Data collection commenced in March 2024, and the results will be ready for publication by January 2025. Feasibility will be determined on the basis of participants\' self-reported engagement with the intervention, and recruitment and retention rates and will be summarized descriptively. We will also consider the amount of missing data and assess how outcomes are related to group assignment. Acceptability will be measured using the modified treatment evaluation inventory and one-to-one semistructured interviews. Transcripts from the interviews will be analyzed using NVivo (version 12; QSR International) software using framework analysis to understand any barriers to the recruitment process, the suitability of the assessment measures, and the acceptability of the intervention and study design.
The study aligns with guidelines developed by the Medical Research Council for developing a complex intervention by using qualitative and quantitative research to examine the barriers of the intervention and identify potential challenges around recruitment and retention. We anticipate that these results will inform the development of a future powered randomized controlled design trial to test the true effectiveness of KOKU-Nut.
ClinicalTrials.gov NCT05943366; https://classic.clinicaltrials.gov/ct2/show/NCT05943366.
PRR1-10.2196/50922.
摘要：
背景：数字健康工具可以支持行为改变，并允许干预措施以最小的成本进行扩展。保持营养（KOKU-Nut）是免费的，基于平板电脑的应用程序，专注于根据英国指南增加体力活动和改善老年人的饮食摄入量。这项干预措施的目标是一个重要的研究领域，该研究领域被詹姆斯·林德联盟报告为营养不良问题设定优先伙伴关系。
目的：本研究旨在评估在社区居住的老年人中使用数字健康工具KOKU-Nut的可行性，以指导未来的随机对照试验。次要目标是确定可接受性，可用性，初步效果大小，以及研究和干预的安全性（KOKU-Nut）。
方法：这是一项可行性随机对照试验。我们计划使用目的抽样招募36名社区居住的老年人。参与者将以1：1的比例随机分配到干预组或对照组。干预组将被要求每周3次与KOKU-Nut接触，持续12周。对照组的参与者将获得宣传健康生活方式的传单。所有研究参与者将在基线和12周结束时完成问卷。参与者的样本将被要求参加可选的面试。该研究将收集一系列数据，包括人体测量学（身高和体重），饮食摄入量（3天食物日记），身体功能（握力和5次坐立），感知生活质量(EQ-5D)，可用性（系统可用性规模），和安全性（不良事件）。
结果：数据收集于2024年3月开始，结果将于2025年1月发布。可行性将根据参与者自我报告参与干预的情况来确定。以及征聘和保留率，并将进行描述性总结。我们还将考虑缺失数据的数量，并评估结果与小组分配的关系。可接受性将使用修改后的治疗评估清单和一对一的半结构化访谈来衡量。面试记录将使用NVivo（版本12；QSRInternational）软件进行分析，使用框架分析来了解招聘过程中的任何障碍，评估措施的适宜性，以及干预和研究设计的可接受性。
结论：该研究与医学研究委员会制定的指南一致，该指南通过使用定性和定量研究来研究干预的障碍并确定招募和保留方面的潜在挑战，从而制定复杂的干预措施。我们预计这些结果将为未来提供动力的随机对照设计试验的发展提供信息，以测试KOKU-Nut的真正有效性。
背景：ClinicalTrials.govNCT05943366;https://classic.clinicaltrials.gov/ct2/show/NCT05943366.
■PRR1-10.2196/50922。
目的：本研究旨在评估在社区居住的老年人中使用数字健康工具KOKU-Nut的可行性，以指导未来的随机对照试验。次要目标是确定可接受性，可用性，初步效果大小，以及研究和干预的安全性（KOKU-Nut）。
方法：这是一项可行性随机对照试验。我们计划使用目的抽样招募36名社区居住的老年人。参与者将以1：1的比例随机分配到干预组或对照组。干预组将被要求每周3次与KOKU-Nut接触，持续12周。对照组的参与者将获得宣传健康生活方式的传单。所有研究参与者将在基线和12周结束时完成问卷。参与者的样本将被要求参加可选的面试。该研究将收集一系列数据，包括人体测量学（身高和体重），饮食摄入量（3天食物日记），身体功能（握力和5次坐立），感知生活质量(EQ-5D)，可用性（系统可用性规模），和安全性（不良事件）。
结果：数据收集于2024年3月开始，结果将于2025年1月发布。可行性将根据参与者自我报告参与干预的情况来确定。以及征聘和保留率，并将进行描述性总结。我们还将考虑缺失数据的数量，并评估结果与小组分配的关系。可接受性将使用修改后的治疗评估清单和一对一的半结构化访谈来衡量。面试记录将使用NVivo（版本12；QSRInternational）软件进行分析，使用框架分析来了解招聘过程中的任何障碍，评估措施的适宜性，以及干预和研究设计的可接受性。
结论：该研究与医学研究委员会制定的指南一致，该指南通过使用定性和定量研究来研究干预的障碍并确定招募和保留方面的潜在挑战，从而制定复杂的干预措施。我们预计这些结果将为未来提供动力的随机对照设计试验的发展提供信息，以测试KOKU-Nut的真正有效性。
背景：ClinicalTrials.govNCT05943366;https://classic.clinicaltrials.gov/ct2/show/NCT05943366.
■PRR1-10.2196/50922。
