NCT05129163

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

Terminated NA Last updated 25 January 2022

What this trial tests

NA trial testing Exercise in Frailty in 219 participants. Terminated before completion.

Timeline

27 August 2018

Primary endpoint
20 December 2019

20 December 2019

Quick facts

Lead sponsor	Academia Sinica, Taiwan
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	219
Start date	27 August 2018
Primary completion	20 December 2019
Estimated completion	20 December 2019
Sites	1 location across Taiwan

Drugs / interventions tested

• Exercise
• Nutrition activities

Conditions studied

• Frailty — all drugs for Frailty →

Sponsor

Academia Sinica, Taiwan — full company profile →

Who can join

65 and older, any sex, with Frailty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of Dietary Intervention with Group Activities on Dietary Intakes, Frailty Status, and Working Memory: A Cluster-Randomized Controlled Trial in Community Strongholds.
   Wu SY, Cheng YY, Chang HY, Wang PH, et al · · 2023 · cited 10× · PMID 37111195 · DOI 10.3390/nu15081976