跳至主要内容
临床试验/NCT05129163
NCT05129163终止不适用

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

Academia Sinica, Taiwan1 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2018年8月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
219
试验地点
1
主要终点
Change from baseline in frailty status at months 3 and 6.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

Exercise

Placebo Comparator

The control group received weekly one-hour group exercise training for 3 months.

干预措施: Exercise (Behavioral)

Exercise and nutrition

Experimental

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.

干预措施: Exercise (Behavioral)

Exercise and nutrition

Experimental

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.

干预措施: Nutrition activities (Behavioral)

结局指标

主要结局

Change from baseline in frailty status at months 3 and 6.

时间窗: 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.

Change from baseline in the ratios of concentration on urinary nutritional biomarkers at months 3 and 6.

时间窗: 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.

Change from baseline in intake frequency (portion per day) on the six food groups at months 3 and 6.

时间窗: 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

次要结局

  • Change from baseline in the score of digit span at months 3 and 6.(Baseline, Month 3 and Month 6)
  • Change from baseline in the scores on the Geriatric Depression Scale at months 3 and 6.(Baseline, Month 3 and Month 6)

研究者

发起方
Academia Sinica, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen-Harn Pan

Distinguished Research Fellow

Academia Sinica, Taiwan

研究点 (1)

Loading locations...

相似试验