Evaluation of the Effect of Healthy Lifestyle Intervention for Patients With Mild Cognitive Impairment

May 5, 2025 updated by: Xuanwu Hospital, Beijing

Preliminary Efficacy and Feasibility Analysis of Cognitive Training, Group Social Activities, Physical Exercise, and MIND Diet in Patients With Mild Cognitive Impairment

This clinical study aims to evaluate the feasibility and preliminary effectiveness of a comprehensive lifestyle intervention program for patients with mild cognitive impairment. The intervention consists of four components: cognitive training, physical exercise, MIND diet, and group social activities.

The hypothesis is that this integrated healthy lifestyle intervention may slow cognitive decline, improve daily functional abilities, and enhance the quality of life in MCI patients. Feasibility will be assessed based on participation rates, program completion rates, and participant satisfaction. Effectiveness will be evaluated using scales such as MoCA, MMSE.

The study participants will be clinically diagnosed mild cognitive impairment patients. If feasibility is confirmed, the results will provide a basis for larger-scale clinical trials and offer insights into non-pharmacological intervention strategies for brain health in high-risk populations.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Research Background

  1. MCI Status and Impact Mild Cognitive Impairment (MCI) is an intermediate state between normal aging and dementia, characterized by cognitive decline. Globally, the prevalence of MCI among individuals aged 65 and older is approximately 15%-20%, while in China, the prevalence among those aged 60 and older is 15.5%, affecting approximately 38.77 million people.

    MCI patients experience cognitive decline, reduced quality of life, and increased economic burden on families (approximately 20%-30% higher than healthy elderly individuals). The prevalence of depressive symptoms in MCI patients is significantly higher than in healthy elderly individuals.

    MCI patients have a high risk of progressing to dementia, with an annual conversion rate of 10%-15%, and up to 50% progressing within five years. However, early intervention can reverse or delay the progression to dementia.

  2. Importance of Healthy Lifestyle Interventions. A healthy lifestyle, including observable behaviors (e.g., diet, exercise) and indirect behaviors (e.g., psychological state, cognitive ability), plays a significant role in preventing and intervening in MCI.

    Exercise Intervention: Regular exercise (e.g., brisk walking, resistance training, Tai Chi) improves cognitive function. It is recommended that older adults with cognitive decline engage in 150-300 minutes of moderate-intensity activity per week.

    Social Intervention: Active social participation (e.g., interest groups, health education) reduces the risk of cognitive decline. It is recommended that MCI patients participate in social activities at least twice a week.

    Dietary Intervention: The MIND diet (a combination of the Mediterranean and DASH diets) emphasizes antioxidant and anti-inflammatory foods, reducing MCI risk and slowing age-related cognitive decline.

    Cognitive Intervention: Cognitive training (e.g., digital cognitive therapy) is effective in improving intervention outcomes. It is recommended that MCI patients undergo at least 3 sessions per week, each lasting 30 minutes, with a total training time of no less than 20 hours.

  3. Research Status and Significance Current research on healthy lifestyle interventions for MCI patients is limited, with most studies focusing on single interventions rather than comprehensive approaches.

This study combines exercise, social activities, diet, and cognitive training to systematically evaluate the comprehensive effects of multidimensional healthy lifestyle interventions. The findings will provide evidence for developing personalized and precise intervention strategies, helping to reduce the risk of dementia conversion, alleviate family and societal burdens, and promote healthy aging.

Statistical Methods The SPSS 23.0 statistical software was used to build the database and conduct statistical analyses. Descriptive statistics were applied to describe the basic characteristics of the study subjects and the outcome indicators of the feasibility analysis. For measurement data, the Shapiro-Wilk test was used to test for normality. Normally distributed data were described using means and standard deviations, while non-normally distributed data were described using medians and interquartile ranges. Categorical data were described using frequencies and percentages.

For the outcome indicators of the effectiveness validation of the study subjects, between-group differences were analyzed. Normally distributed data were analyzed using the independent samples t-test, while non-normally distributed data were analyzed using the Mann-Whitney U test. A two-tailed p-value ≤0.05 was considered statistically significant.

Innovations

  1. Perspective Innovation Starting from an overall healthy lifestyle and focusing on MCI patients, this study integrates multi-factorial interventions (exercise, diet, social interaction, and cognitive training), breaking the limitations of traditional single-factor research. Meanwhile, the intervention effects are evaluated from multiple dimensions to comprehensively measure the impact of lifestyle interventions on MCI patients.
  2. Methodological Innovation Combining multi-modal interventions (cognitive training, exercise, MIND diet, group social activities) with digital technology (cognitive digital therapy, fitness trackers for heart rate monitoring), this study enables real-time multi-dimensional monitoring and data collection, enhancing intervention compliance and engagement.
  3. Application Innovation Focusing on modifiable factors in the lives of MCI patients, this study designs practical interventions that can be implemented in both family and community settings. Based on the research findings, an integrated promotion model of "hospital-community-family" can be established to effectively improve the accessibility and sustainability of the interventions.
  4. Research Framework Innovation This study constructs a comprehensive intervention framework that integrates diet, exercise, cognition, and social interaction, providing a reference for future research.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100053
        • Xuanwu Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. To meet the diagnostic criteria of MCI, refer to the diagnostic criteria of MCI in "2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Impairment (5) : Diagnosis and Treatment of Mild Cognitive Impairment".
  2. Have caregiver > 6 months.
  3. Participate in the study voluntarily and sign the informed consent.

Exclusion Criteria:

  1. Have received other cognitive intervention therapy recently (within 6 months).
  2. Diagnosis of functional encephalopathy or obvious mental disorders, such as Parkinson's disease, epilepsy, schizophrenia.
  3. Suffering from serious cardiovascular diseases, malignant tumors and other major physical diseases.
  4. Have visual, hearing, speech or limb dysfunction, unable to complete the test.
  5. Patients with chronic diseases who have special dietary needs or require special dietary management.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: the comprehensive intervention group
The intervention measures of the comprehensive intervention group were divided into exercise intervention, group socializing, MIND diet education and cognitive training. Twice a week for eight weeks.
Behavioral: Exercise intervention

The multi-component exercise mode is adopted, and the three-stage structured design of "warm-up preparation - main training - finishing and relaxation" is adopted, and the participants' heart rate is monitored in real time with the exercise bracelet throughout the whole process to ensure that the training intensity is reached. The movement process is guided synchronously by the video music teaching system, and the specific process is as follows:

  1. Warm-up preparation (3 minutes) : Warm up the head and neck, shoulder joints, arms and wrists, waist and abdomen, thighs and ankles in turn, and perform 30 seconds for each movement.
  2. Main training stage (60min) : aerobic exercise adopts basic steps of square dance or advanced step training; The resistance training module carries out compound resistance exercises of sitting posture, leg lift and arms forward lift.
  3. Finishing and relaxing stage (12min) : select the traditional health exercise eight Duan Jin.
Behavioral: Social intervention

The duration of each intervention was 40min, mainly group social interaction, guided by professionals (medical social workers). Divided into three stages:

The first stage (3min) : The facilitator will go through small jokes, soothing music, etc.Create a relaxed atmosphere and briefly introduce the theme of the week.

The second stage (35min) : During the activity, participants began to chat around the theme, and the host guided them timely.

The third stage (2min) : Summarize the intervention and praise the participants.

Behavioral: Dietary intervention
The researcher distributed the health education manual of the cognitive disorder diagnosis and treatment center, and conducted a 5-minute MIND diet health education, explaining relevant dietary requirements and focusing on the collocation of one type of food every week. The participants were then given homework that asked them to strictly follow the MIND diet in their daily diet. At the same time, the participants' caregivers are required to upload photos of their daily meals to the wechat group for supervision and feedback.
Behavioral: Cognitive intervention
Cognitive digital therapy was adopted, and participants were supervised by their caregivers for 5 days a week and 30min each time for cloud-based home training (avoiding 2 hospital intervention days) for 8 weeks. The training covers core cognitive functions such as attention, memory and logical reasoning.
Behavioral: Health Education Manual
Distribute health education handbooks to guide patients to establish a good awareness of a healthy lifestyle. The manual can popularize health knowledge, covering various aspects such as diet, exercise, and rest, enabling patients to understand the importance of a healthy lifestyle, encouraging them to actively improve their living habits, slow down the progression of the disease, and enhance their quality of life.
Sham Comparator: the usual care group
The usual care group was given a health education booklet on the importance of proper diet, physical activity, cognitive exercise, and social interaction to help participants establish a basic understanding of these healthy lifestyles and try to do them. The manual teaches about common healthy ingredients, the appropriate frequency and intensity of aerobic exercise, and the benefits of brain games, reading, and learning new skills. And specific forms of social communication, such as participation in community activities, regular gatherings with relatives and friends.
Behavioral: Health Education Manual
Distribute health education handbooks to guide patients to establish a good awareness of a healthy lifestyle. The manual can popularize health knowledge, covering various aspects such as diet, exercise, and rest, enabling patients to understand the importance of a healthy lifestyle, encouraging them to actively improve their living habits, slow down the progression of the disease, and enhance their quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation rate
Time Frame: Baseline
Recruitment success rate : number of people who agree to participate/total number of people eligible and invited
Baseline
Study Measures Completion
Time Frame: 4 weeks and 8weeks
Number of participants with full protocol compliance, including: attending interventions as scheduled, verifying target exercise intensity via fitness trackers, and recording MIND diet adherence in the WeChat group.
4 weeks and 8weeks
Montreal Cognitive Assessment
Time Frame: Baseline and 8 weeks
Seven sub-dimensions, including visuospatial/executive function, naming, attention, language, abstract ability, delayed recall and orientation, were scored out of 30, with higher scores indicating better cognitive ability. The sensitivity and specificity of the Beijing version of MoCA scale were 0.92, 0.84, 0.86, and 0.82 Cronbach'sa coefficient of internal consistency.
Baseline and 8 weeks
Mini-Mental State Examination
Time Frame: Baseline and 8 weeks
The scale includes the assessment of orientation, attention and computing ability, immediate recall, delayed recall, language function and visuospatial ability. The total score is 30 points, the higher the score is, the better the cognitive function, >27 is normal, <27 is cognitive dysfunction. The Chinese MMSE retest reliability is 0.90.
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Support Rating Scale
Time Frame: Baseline and 8 weeks
The scale consisted of 10 items and 3 dimensions (subjective support, objective support and utilization of social support), with a total score of 12 to 66 points, and the higher the score, the better the social support. The retest reliability of the scale was 0.92, and the prediction validity was good.
Baseline and 8 weeks
Geriatric Depression Scale
Time Frame: Baseline and 8 weeks
Geriatric Depression Scale is adapted by Sheikh and other scholars on the basis of the standard edition, with a total of 15 items, each item is 1 point. The scale scores range from 0 to 15 points. The higher the score, the more likely it is to have depressive symptoms. The Chinese version of GDS-15 scale has good applicability in the elderly population in China, with a one-week retest reliability of 0.728 and a Cronbach'sa coefficient of 0.793.
Baseline and 8 weeks
General information questionnaire
Time Frame: Baseline
demographic information (age, sex, education, marital status, etc.), health status (medical history, drug use, smoking and alcohol use), lifestyle (physical activity, eating habits, social activities).
Baseline
Occurrence of adverse events
Time Frame: From enrollment to the end of the intervention at eight weeks
The number of cases of falls and muscle injuries during exercise, indigestion and gastrointestinal reactions caused by following the MIND diet
From enrollment to the end of the intervention at eight weeks
12-item Short-Form Health Survey
Time Frame: Baseline and 8 weeks
The total score of the scale ranges from 12 to 65 points. The higher the scale score, the better the quality of life. When the 12-item Short-Form Health Survey was applied to the elderly population in China, the Cronbach'sa coefficient of the scale was 0.775, indicating good reliability and validity.
Baseline and 8 weeks
Satisfaction Questionnaire
Time Frame: 8weeks
The satisfaction questionnaire covers four aspects (cognitive training, exercise, MIND diet and social activities), and gives the scores of acceptability (interest/difficulty), time commitment and overall satisfaction (5-point Likert scale), with a total score ranging from 13 to 65 points. The higher the score is, the more satisfied one will be. Open-ended questions will collect suggestions for improvement.
8weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 16, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data Sensitivity: Cognitive health datasets contain detailed personal health and lifestyle information that, even anonymized, could carry re-identification risks for vulnerable populations like older adults.

Resource Limitations: Our team currently lacks dedicated infrastructure to responsibly anonymize, curate, and manage external data requests while ensuring compliance with evolving data protection laws.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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