Clinical trial NCT05129163: Effects of Community-center Based Dietary Intervention on Frailty Prevention and Regression in the Elderly.
Official title: Associations Between Various Geriatric Syndromes and Nutrition Status and Dietary Pattern in Elderly
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Frailty
Lead sponsor: Academia Sinica, Taiwan
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 219
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in intake frequency (portion per day) on the six food groups at months 3 and 6.
timeFrame: Baseline, Month 3 and Month 6
measure: Change from baseline in the ratios of concentration on urinary nutritional biomarkers at months 3 and 6.
timeFrame: Baseline, Month 3 and Month 6
measure: Change from baseline in frailty status at months 3 and 6.
timeFrame: Baseline, Month 3 and Month 6
Secondary outcomes:
measure: Change from baseline in the score of digit span at months 3 and 6.
timeFrame: Baseline, Month 3 and Month 6
measure: Change from baseline in the scores on the Geriatric Depression Scale at months 3 and 6.
timeFrame: Baseline, Month 3 and Month 6
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Institute of Biomedical Sciences, Academia Sinica
Study officials:
affiliation: Academia Sinica, Taiwan
name: Wen-Harn Pan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsieh TJ, Su SC, Chen CW, Kang YW, Hu MH, Hsu LL, Wu SY, Chen L, Chang HY, Chuang SY, Pan WH, Hsu CC. Individualized home-based exercise and nutrition interventions improve frailty in older adults: a randomized controlled trial. Int J Behav Nutr Phys Act. 2019 Dec 2;16(1):119. doi: 10.1186/s12966-019-0855-9.
citation: Wu SY, Hsu LL, Hsu CC, Hsieh TJ, Su SC, Peng YW, Guo TM, Kang YW, Pan WH. Dietary education with customised dishware and food supplements can reduce frailty and improve mental well-being in elderly people: A single-blind randomized controlled study. Asia Pac J Clin Nutr. 2018;27(5):1018-1030. doi: 10.6133/apjcn.032018.02.