A Multifaceted Nutrition Intervention for Frailty in the Community Elderly

ConditionsFrail Elderly Nutrition Disorders in Old Age

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65-85

SponsorZhaofeng Zhang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Frailty assessed by the frail phenotype

Aged between 65 and 85 years old

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

multifaceted nutrition intervention
Behavioral
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.
Nutritional and Exercise Combined Intervention
Behavioral
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.
Control Group
Behavioral
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.

Treatment groups

315 Participants

are divided into 3 treatment groups

Group A: Nutritional Intervention GroupExperimental treatment 1 intervention

Group B: Nutritional and Exercise Combined Intervention GroupExperimental treatment 1 intervention

Group C: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Short Physical Performance Battery (SPPB) score

The primary outcome was the change in the Short Physical Performance Battery (SPPB) score between groups, and the change from baseline to the end of the study.

Time frame

at the 3-month intervention and at the 3-month, 6-monthand 12-month follow-up investigations

frailty scores

The frailty scores were evaluated using Fried Frailty Phenotype and Tilburg Frailty Indicator

Time frame