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Effects of Community-center Based Dietary Intervention on Frailty Prevention and Regression in the Elderly.

2022年1月10日 更新者:Wen-Harn Pan、Academia Sinica, Taiwan

Associations Between Various Geriatric Syndromes and Nutrition Status and Dietary Pattern in Elderly

Recent interventional studies have shown that frailty can be improved by modifying dietary quality. In this study, a set of nutrition-centric health promotion activities was developed in accordance with the Taiwanese Daily Food Guide for elderly participants of the community centers to improve their nutrition in everyday practice and examined the efficacy of these activities on slowing down the development or regression of frailty. The study was a cluster-randomized controlled trial. Recruited community centers were randomly assigned into either the control or the intervention group. The intervention period lasted for 3 months. Both the control and intervention groups received weekly one-hour group exercise training. The intervention group had an additional weekly one-hour group nutrition session. The intervention programs included: (a) training on-site staffs to use motivational interview techniques to communicate, to estimate participant's energy requirements, and to learn how to provide proper amounts of foods to individual elderlies, (b) nutrition grouped activities on ①know my plate, ②wholegrains, ③drinking teas with dairy, and nuts, ④novel ways to eat fruit and vegetables, ⑤healthy breakfast ideas. In the first month, participants were intervened with the activities laid out above; in the second month, participants were intervened with qualitative discussions on dietary changes; in the third month, participants were intervened with designed activities that helped break down barriers in order to establish a long-term change in dietary habits. Improvement in nutritional status was the primary outcome. Secondary outcomes included frailty scores, physical performance, and mental health. The measurements were performed at baseline, 3 months, and 6 months.

研究概览

研究类型

介入性

注册 (实际的)

219

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taipei、台湾、115
        • Institute of Biomedical Sciences, Academia Sinica

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Aged 65 years or older
  • Able to walk independently for 14 meters within 1 minute
  • Willing to sign the informed consent

Exclusion Criteria:

  • Under dietary control by doctors' instructions
  • With mental illness, mental disorders, or unable to communicate
  • With severe diseases such as under treatments for cancer

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:Exercise
The control group received weekly one-hour group exercise training for 3 months.
The group exercise training was held in each community center. The group exercise training contained aerobic exercise, complex physical fitness exercise, muscle training, and balance and coordination training.
实验性的:Exercise and nutrition
The intervention group had weekly one-hour group exercise training the same as the control and an additional weekly one-hour group nutrition session for 3 months.
The group exercise training was held in each community center. The group exercise training contained aerobic exercise, complex physical fitness exercise, muscle training, and balance and coordination training.
The intervention programs included: (a) training on-site staffs to use motivational interview techniques to communicate, to estimate participant's energy requirements, and to learn how to provide proper amounts of foods to individual elderlies, (b) nutrition grouped activities on ①know my plate, ②wholegrains, ③ drinking teas with dairy, and nuts, ④novel ways to eat fruit and vegetables, ⑤healthy breakfast ideas. In the first month, participants were intervened with the activities laid out above; in the second month, participants were intervened with qualitative discussion on elders' dietary changes; in the third month, participants were intervened with designed activities that helped break down barriers in order to establish a long-term change in dietary habits.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from baseline in intake frequency (portion per day) on the six food groups at months 3 and 6.
大体时间:Baseline, Month 3 and Month 6

The six food groups include:

  1. Whole grains and starchy vegetables
  2. Protein foods: soy beans, fish, eggs, and meat
  3. Vegetables
  4. Fruits
  5. Dairy
  6. Oils, nuts and seeds
Baseline, Month 3 and Month 6
Change from baseline in the ratios of concentration on urinary nutritional biomarkers at months 3 and 6.
大体时间:Baseline, Month 3 and Month 6

The concentrations of the following urinary nutritional biomarkers were determined: urinary urea nitrogen (mg/dL), urinary calcium (mg/dl), urinary potassium (mmol/L), urinary magnesium (mg/dL), and urinary creatinine (mg/dL).

The urinary urea nitrogen to creatinine ratios, urinary calcium to creatinine ratios, urinary potassium to creatinine ratios, and urinary magnesium to creatinine ratios was estimated at baseline, moths 3 and 6.

Baseline, Month 3 and Month 6
Change from baseline in frailty status at months 3 and 6.
大体时间:Baseline, Month 3 and Month 6

Frailty status was defined using modified Linda Fried criteria with cutoff points from the investigators' previous intervention studies.

Five frail phenotypes were assigned: (1) unintentional weight loss, (2) self-reported exhaustion, (3) weak grip strength, (4) slow gait speed, and (5) low level of physical activity. To estimate frailty, participants scored 1 point from each phenotype if any of these were satisfied; a maximum score of five was possible. Participants were classified by their point scores as follows: 'robust' for 0 point; 'pre-frail' for 1 or 2 points; and 'frail' for ≥3.

Baseline, Month 3 and Month 6

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in the score of digit span at months 3 and 6.
大体时间:Baseline, Month 3 and Month 6
A digit span task is used to measure working memory's number storage capacity. Subjects are read a sequence of numbers and asked to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span). The score is the length of the longest correctly repeated sequence. The maximum number of digits in a sequence is 9 and the minimum number of digits in a sequence is 2. The higher scores mean a better outcome.
Baseline, Month 3 and Month 6
Change from baseline in the scores on the Geriatric Depression Scale at months 3 and 6.
大体时间:Baseline, Month 3 and Month 6
The Geriatric Depression Scale (GDS) is a self-report measure of depression in older adults. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Baseline, Month 3 and Month 6

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Wen-Harn Pan, PhD、Academia Sinica, Taiwan

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年8月27日

初级完成 (实际的)

2019年12月20日

研究完成 (实际的)

2019年12月20日

研究注册日期

首次提交

2021年10月28日

首先提交符合 QC 标准的

2021年11月10日

首次发布 (实际的)

2021年11月22日

研究记录更新

最后更新发布 (实际的)

2022年1月25日

上次提交的符合 QC 标准的更新

2022年1月10日

最后验证

2022年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • AS-IRB01-16057

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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