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

NCT06942780 | Not Yet Recruiting

• 1 other identifier: 202504
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Cognitive training; MIND diet; social; exercise

Outcome Measures

Primary Outcomes (4)

• Participation rate

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

  Baseline

• 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.

  4 weeks and 8weeks

• 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.

  Baseline and 8 weeks

• 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.

  Baseline and 8 weeks

Secondary Outcomes (6)

• 12-item Short-Form Health Survey

  Baseline and 8 weeks

• Social Support Rating Scale

  Baseline and 8 weeks

• Geriatric Depression Scale

  Baseline and 8 weeks

• General information questionnaire

  Baseline

• Satisfaction Questionnaire

  8weeks

Study Arms (2)

the usual care group

SHAM COMPARATOR

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

the comprehensive intervention group

ACTIVE COMPARATOR

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; Behavioral: Social intervention; Behavioral: Dietary intervention; Behavioral: Cognitive intervention; Behavioral: Health Education Manual

Interventions

Exercise intervention BEHAVIORAL

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.

the comprehensive intervention group

Social intervention BEHAVIORAL

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.

the comprehensive intervention group

Dietary intervention BEHAVIORAL

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.

the comprehensive intervention group

Cognitive intervention BEHAVIORAL

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.

the comprehensive intervention group

Health Education Manual BEHAVIORAL

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.

the comprehensive intervention group; the usual care group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

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MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Interventions

Social Work; Diet Therapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services; Nutrition Therapy; Therapeutics

Central Study Contacts

Yuchen Qiao

CONTACT

+8615010030330; qiaoyc2015@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 24, 2025
• Study Start: May 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)