A Multifaceted Nutrition Intervention for Frailty in the Community Elderly

Summary

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.

Conditions

• Frail
• Elderly
• Nutrition Disorders in Old Age

Interventions

BEHAVIORAL

multifaceted nutrition intervention

In this group, a 3-month multifaceted nutrition intervention will be conducted. The specific content is as follows: 1. Anti-inflammatory dietary management: the elderly will receive an anti-inflammatory dietary menu designed based on the Chinese Dietary Guidelines for the Elderly (2022 Edition) provided by researchers. 2. Personalized nutritional intervention management: WeChat groups will be established to record the dietary status of the research subjects. The research subjects will be asked to keep a dietary diary and take photos of their diet daily. Trained researchers will record their daily diet and provide timely feedback to the research subjects. 3. Health education: Nutrition and health knowledge lecture will be held for elderly family caregivers and the elderly themselves every two weeks. The content will include basic knowledge of frailty, prevention and treatment guidance, health outcomes, medication management, and healthy behaviors.

BEHAVIORAL

Nutritional and Exercise Combined Intervention

To investigate the combined effects of nutrition and exercise, this group added exercise intervention in addition to the corresponding intervention measures of the nutrition intervention group. The subjects were required to exercise 3 times a week, 1 hour each time. The project included 10 minutes of warm-up exercises (stretching), 10-20 minutes of aerobic exercise (balance ability, leg and core muscle strength, etc.), 10-20 minutes of muscle resistance strength training (legs, buttocks, feet, upper limbs, etc.) and 10 minutes of relaxation training. All exercise programs were uniformly trained by professional coaches, and compliance was ensured by uploading photos to punch the clock. The intervention period is 3 months, with a follow-up of 9 months.

BEHAVIORAL

Control Group

The control group will undergo routine community health management, including regular chronic disease health education lectures, provision of health education materials, health counseling services, and comprehensive health examinations by qualified medical professionals.

Sponsors & Collaborators

• Zhaofeng Zhang

  lead OTHER

Principal Investigators

• Zhaofeng Zhang, Doctor · Peking University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-30

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• China

Study Locations