A Multifaceted Nutrition Intervention for Frailty in the Community Elderly
Recruiting now · Not applicable
Conditions studied: Frail, Elderly, Nutrition Disorders in Old Age
In brief
With world's older population is rapidly increasing. China's population aging process is also accelerating. Studies have shown that persistent frailty can increase the incidence of negative events in the elderly. However, research on elderly frailty in China is still in its early stages, and existing research in China mainly focuses on the definition of frailty, evaluation tools for frailty, and cross-sectional surveys of small populations. There is currently limited research on interventions. The MultIfaceted NUtrition inTErvention for Frailty (minute) trial is a randomized, controlled trial to explore the trajectory characteristics and influencing factors of frailty in the community, the impact of nutritional interventions on the developmental trajectory of frailty in the elderly in the community and the management model and appropriate technology for the sustainable intervention of frailty in the elderly based on the community. A total of 315 frail older adults will be recruited from Beijing. After the screening period, the compliant participants will be randomized to the control group, the nutrition intervention group with the nutrition intervention alone, or the combined nutrition intervention group with combining exercise and nutrition, on a 1:1:1 ratio, for 3 months. The primary outcome is the change in SPPB from the baseline to the end of the study. The change in SPPB as a primary outcome, and frailty status, demographic information, health status, nutrition assessment, comprehensive geriatric assessment status, quality of life, intrinsic capacity, and mental elasticity as secondary outcomes will be measured using validated questionnaires and clinical examinations. This trial adheres to the Declaration of Helsinki and guidelines of Good Clinical Practice. Signed informed consent will be obtained from all participants. The trial has been approved by the Peking University Institutional Review Board (approval number: IRB00001052-23178). The results will be disseminated through academic conferences and publications in international peer-reviewed journals.
Key facts
- Study ID
- NCT06547593
- Run by
- Zhaofeng Zhang
- People needed
- 315
- Starts
- 2024-07-30
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2024-08-09
Who can join
Age: 65 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Frailty assessed by the frail phenotype
- Aged between 65 and 85 years old
You may not qualify if…
- Multiple serious diseases such as stroke, cerebral infarction, tumors, and severe cardiovascular and cerebrovascular diseases
- Disability, dementia; severe visual and hearing impairments, and physical activity impairment
- Moderate to severe anxiety and depression
- Unable to complete this study as requested
Where it is running
- Qingta Community Health Service Center — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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