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Mild Cognitive Impairment (MCI)NCT06942780

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

A study testing Exercise intervention, Social intervention and Dietary intervention in people with Mild Cognitive Impairment (MCI), run by Xuanwu Hospital, Beijing at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Mild Cognitive Impairment (MCI)
What is being tested?
Exercise intervention, Social intervention and Dietary intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteChina
Study dates
May 2025to Aug 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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".
  • Have caregiver > 6 months.
  • Participate in the study voluntarily and sign the informed consent.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yuchen Qiao contact

+8615010030330

qiaoyc2015@163.com

China1 site

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053

    Yuchen Qiao, +8615010030330, qiaoyc2015@163.com

Other trials in China

About this study

Official title: 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.

Read the 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.
Being tested
Exercise intervention, Social intervention, Dietary intervention, Cognitive intervention, Health Education Manual
Keywords
Cognitive training, MIND diet, social, exercise
Medical subject headings
Cognitive Dysfunction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise interventionBehavioural

    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.

  • Social interventionBehavioural

    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.

  • Dietary interventionBehavioural

    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.

  • Cognitive interventionBehavioural

    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.

  • Health Education ManualBehavioural

    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.

Study groups in NCT06942780
Study groupRoleWhat they receive
the usual care groupSham comparatorThe 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.
Receives: Behavioral: Health Education Manual
the comprehensive intervention groupActive comparatorThe 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.
Receives: Behavioral: Exercise intervention; Behavioral: Social intervention; Behavioral: Dietary intervention; Behavioral: Cognitive intervention; Behavioral: Health Education Manual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participation rate

    Recruitment success rate : number of people who agree to participate/total number of people eligible and invited

    Measured: Baseline

  2. Study Measures Completion

    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.

    Measured: 4 weeks and 8weeks

  3. Montreal Cognitive Assessment

    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.

    Measured: Baseline and 8 weeks

  4. Mini-Mental State Examination

    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.

    Measured: Baseline and 8 weeks

Secondary outcomes (6)

  1. 12-item Short-Form Health Survey

    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.

    Measured: Baseline and 8 weeks

  2. Social Support Rating Scale

    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.

    Measured: Baseline and 8 weeks

  3. Geriatric Depression Scale

    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.

    Measured: Baseline and 8 weeks

  4. General information questionnaire

    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).

    Measured: Baseline

  5. Satisfaction Questionnaire

    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.

    Measured: 8weeks

  6. Occurrence of adverse events

    The number of cases of falls and muscle injuries during exercise, indigestion and gastrointestinal reactions caused by following the MIND diet

    Measured: From enrollment to the end of the intervention at eight weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06942780
Sponsor's protocol ID
202504
Status last verified
May 2025
First submitted
16 Apr 2025
Last updated
9 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Zhang Lixiu, Liu Xueqin. Study on the reliability and validity of the Chinese version of the Montreal Cognitive Assessment Scale J. Nursing Research, 2007, (31): 2906-7.

  • The theoretical basis and research application of Social Support Rating Scale J. Journal of Clinical Psychiatry, 1994, (02): 98-100.

  • Zhou Xiaoxuan, Xie Min, Tao Jing, et al. Research and application of simple intelligent mental state examination scale J. Chinese Journal of Rehabilitation Medicine, 2016, 31(06): 694-696.

  • Mitchell AJ, Bird V, Rizzo M, Meader N. Diagnostic validity and added value of the Geriatric Depression Scale for depression in primary care: a meta-analysis of GDS30 and GDS15. J Affect Disord. 2010 Sep;125(1-3):10-7. doi: 10.1016/j.jad.2009.08.019. Epub 2009 Oct 2.

    PubMed 19800132

  • Sheikh J. Geriatric depression scale (GDS): recent evidence and development of ashorter version J. Clin Gerontol, 1986, 5(1): 165-173.

  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PubMed 8628042

  • Chinese Expert Consensus Committee on Brain and Cognitive Health Management, Editorial Committee of Chinese Journal of Health Management. Chinese expert consensus on brain cognitive health management (2023) J. Chinese Journal of Health Management, 2023, 17(12): 881-892.

  • Special Committee of Neurodegeneration, Chinese Society of Microcirculation, Neuropsychological and Behavioral Neurology Group, Chinese Society of Neurology, Neurorehabilitation Group, Chinese Society of Neurology. Chinese expert consensus on rehabilitation management of Alzheimer's disease J. Chinese Journal of Gerontology, 2020, 39(1): 9 19.

  • Expert group on Exercise Prescription in China Expert Consensus (2023). Chinese expert consensus on exercise prescription (2023) J. Chinese Journal of Sports Medicine, 2023, 42(1): 3 13.

  • Chinese Geriatrics Society. [Chinese expert consensus on multidisciplinary decision-making model for mobility limitation in older adults (2024 edition)]. Zhonghua Yi Xue Za Zhi. 2024 Mar 26;104(12):893-905. doi: 10.3760/cma.j.cn112137-20230816-00238. Chinese.

    PubMed 38514338

  • China Geriatric Nursing Alliance, Xiangya Nursing School of Central South University (Xiangya Pan-Sea Health Management Research Institute of Central South University), Xiangya Hospital of Central South University (National Clinical Medical Research Center for Geriatric Diseases), etc. Clinical practice guidelines for non-drug intervention in the elderly with cognitive decline: Physical activity J. Chinese Journal of General Medicine, 2023, 26(16): 1927-1937+1971.

  • Committee for the preparation of Physical Activity Guidelines for Chinese People. Physical activity guidelines for Chinese population (2021) J. Chinese Journal of Epidemiology, 2022, 43(1): 56.

  • American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.

    PubMed 19516148

  • McMaster M, Kim S, Clare L, Torres SJ, D'Este C, Anstey KJ. Body, Brain, Life for Cognitive Decline (BBL-CD): protocol for a multidomain dementia risk reduction randomized controlled trial for subjective cognitive decline and mild cognitive impairment. Clin Interv Aging. 2018 Nov 21;13:2397-2406. doi: 10.2147/CIA.S182046. eCollection 2018.

    PubMed 30538436

  • Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.

    PubMed 32738937

Questions about this trial

What is this clinical trial studying?

A study testing Exercise intervention, Social intervention and Dietary intervention in people with Mild Cognitive Impairment (MCI), run by Xuanwu Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuchen Qiao (+8615010030330, qiaoyc2015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participation rate (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06942780, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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