A Multifaceted Nutrition Intervention for Frailty in the Community Elderly

NCT06547593 | Recruiting

• 1 other identifier: MINUTE
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

multifaceted nutrition; frail; elderly; community

Outcome Measures

Primary Outcomes (2)

• 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.

  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

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

Secondary Outcomes (13)

• frailty trajectories

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

• intrinsic capacity

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

• Malnutrition risk assessment

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

• frailty recovery rates

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

• Serum protein

  at the 3-month intervention and at the 3-month and 12-month follow-up investigations

Study Arms (3)

Nutritional Intervention Group

EXPERIMENTAL

In this group, based on routine health management, a 3-month multifaceted nutrition intervention and a 9-month follow-up 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: To ensure the compliance and participation of the elderly, a variety of health intervention materials will be provided. WeChat groups will be established to record the dietary status of 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.

Behavioral: multifaceted nutrition intervention

Nutritional and Exercise Combined Intervention Group

EXPERIMENTAL

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: Nutritional and Exercise Combined Intervention

Control Group

PLACEBO COMPARATOR

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. At the beginning and end of the intervention, as well as at a 9-month follow-up, the study subjects were evaluated to understand the sustainability of the intervention after the project was completed, and to explore the management mode of sustainable intervention.

Behavioral: Control Group

Interventions

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 Intervention Group

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.

Nutritional and Exercise Combined Intervention Group

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.

Control Group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• Zhaofeng Zhang: lead

Study Sites (1)

Qingta Community Health Service Center

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

• Han Y, Zhang H, Sun M, Ma Y, Tu Y, Tian J, Fan R, Zhu W, Zhang Z. Multifaceted Nutrition Intervention for Frail Elderly in the Community: Protocol of a Randomized Controlled Trial (The MINUTE Study). Nutrients. 2025 Oct 13;17(20):3213. doi: 10.3390/nu17203213.

  PMID: 41156465 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zhaofeng Zhang, Doctor

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaofeng Zhang, Doctor

CONTACT

86-10-82801575; zhangzhaofeng@bjmu.edu.cn

Rui Fan, Doctor

CONTACT

86-10-82801575; rfcaubj@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 9, 2024
• Study Start: July 30, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (1)