Multifaceted Nutrition Intervention for Frail Elderly in the Community: Protocol of a Randomized Controlled Trial (The MINUTE Study).
Yaxin Han, Haohao Zhang, Meng Sun...
https://pubmed.ncbi.nlm.nih.gov/41156465Actively Recruiting
Phase Not Applicable
Age: 65Years - 85Years
All Genders
ID06547593
A Multifaceted Nutrition Intervention for Frailty in the Community Elderly: a Randomized Controlled Trial
Led by Zhaofeng Zhang · Updated on 2024-08-09
315
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
The global population of older adults is rapidly growing, with a significant increase in those aged 65 and over, especially in China. Frailty, a condition marked by reduced strength and function across multiple body systems, is common among the elderly and can lead to serious health issues such as falls, disability, hospitalization, and increased mortality. This trial aims to explore the characteristics and influencing factors of frailty in community-dwelling older adults in China, as well as to evaluate how nutritional and combined nutrition-exercise interventions affect frailty progression and management in this population. Participants will be randomly assigned to one of three groups for a 3-month intervention period followed by a 9-month follow-up. The first group receives a multifaceted nutrition intervention including anti-inflammatory dietary plans, personalized nutritional management with daily dietary tracking via WeChat, and biweekly health education sessions for participants and caregivers. The second group receives the same nutrition intervention combined with a structured exercise program conducted three times a week, featuring warm-up, aerobic, resistance strength, and relaxation training overseen by professional coaches. The control group will continue with routine community health management including chronic disease education, counseling, and health examinations. During the study, participants will undergo evaluations at baseline, after the 3-month intervention, and at 3, 6, and 12 months follow-up to assess physical performance using the Short Physical Performance Battery (SPPB) and frailty scores. Additional measures include assessments of frailty trajectories, nutritional risk, intrinsic capacity, quality of life, cognitive function, sleep quality, serum protein and inflammatory markers, and adverse events. Data will be collected via validated questionnaires, clinical exams, and laboratory tests to understand the sustainability and impact of the interventions over time.
CONDITIONS
Brief Title
A Multifaceted Nutrition Intervention for Frailty in the Community Elderly
Who Can Participate
Age: 65Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Frailty assessed by the frail phenotype
- Aged between 65 and 85 years old
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Behavioral Intervention
Duration - 3 months
Participants receive a 3-month multifaceted nutrition intervention or a combined nutrition and exercise intervention. Nutrition intervention includes anti-inflammatory dietary management, personalized nutritional support via WeChat groups, and biweekly health education lectures. The combined intervention adds thrice-weekly 1-hour exercise sessions led by professional coaches.
Biweekly visits for health education and regular monitoring throughout the 3 months
Follow-up
Duration - 9 months
Participants are followed for 9 months after completing the intervention to monitor sustainability of benefits, physical performance, frailty scores, cognition, sleep conditions, and adverse events.
Assessments at 3, 6, and 12 months after intervention start
Trial Site Locations
Total: 1 location
1
Qingta Community Health Service Center
Beijing, Beijing Municipality, China
Actively Recruiting
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Research Team
Z
Zhaofeng Zhang, Doctor
R
Rui Fan, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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