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Intervention for Preventing Myopia and Multimorbidity in Children

NCT ID: NCT07294222

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-30

Study Completion Date

2027-01-30

Brief Summary

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This study aims to develop and evaluate a scalable, hybrid intervention model for the co-prevention of myopia, obesity, and mental health issues among children. By integrating cognitive behavioral therapy principles, the model targets key modifiable lifestyle factors-including dietary nutrition, physical activity, screen time, sleep hygiene, light exposure, and psychological adaptation-through coordinated family-school engagement and online-to-offline delivery. Using a cluster randomized controlled trial design in grades 3-4 primary school students, the research will assess the effectiveness of this multi-component strategy in reducing the incidence and burden of these co-occurring conditions.

Detailed Description

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This study employs a real-world, cluster randomized controlled trial (cRCT) design conducted in primary school settings. Participants will be provided with a 6-month integrated health education program involving both families and schools, accompanied by sustained environmental modifications to support healthy behaviors. Data will be collected at four time points: baseline, immediately after the intervention, 6 months, and 12 months post-baseline, to evaluate the short- and medium-term effects of the intervention.

Conditions

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Myopia Mental Health Cardiovascular Health Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Usual Education Control Group

Participants in this group continue with their usual school health education curriculum and do not receive the specific interventions of this study.

Group Type ACTIVE_COMPARATOR

Standard School Health Education

Intervention Type BEHAVIORAL

Participants receive the existing health education curriculum as provided by their school, following the standard national or local guidelines, without the additional components of the study's intervention package.

Comprehensive Lifestyle Intervention Group

Participants in this group receive a multi-component health promotion intervention, including animated health education videos, fun health lectures, family-school environment support, and encouragement of outdoor activities using wearable devices.

Group Type EXPERIMENTAL

Multi-component Health Promotion Package

Intervention Type BEHAVIORAL

A 24-week program integrating: 1) Weekly animated video-based health lessons; 2) Interactive debates and handbook activities; 3) Family engagement via handbooks, meetings, and WeChat updates; 4) Health knowledge reinforcement based on fun health lectures; 5) Creation of a 'Healthy Living Corner' in classrooms; 6) Temporary use of wearable devices to monitor and encourage outdoor activity and sleep.

Interventions

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Standard School Health Education

Participants receive the existing health education curriculum as provided by their school, following the standard national or local guidelines, without the additional components of the study's intervention package.

Intervention Type BEHAVIORAL

Multi-component Health Promotion Package

A 24-week program integrating: 1) Weekly animated video-based health lessons; 2) Interactive debates and handbook activities; 3) Family engagement via handbooks, meetings, and WeChat updates; 4) Health knowledge reinforcement based on fun health lectures; 5) Creation of a 'Healthy Living Corner' in classrooms; 6) Temporary use of wearable devices to monitor and encourage outdoor activity and sleep.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children in grades 3-4, aged 8-11 years.
* Informed consent obtained.

Exclusion Criteria

* Presence of systemic diseases (e.g., endocrine, cardiac, psychiatric disorders).
* Presence of developmental abnormalities.
* Inability to complete the follow-up.
Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fangbiao Tao

OTHER

Sponsor Role lead

Responsible Party

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Fangbiao Tao

Director of the Key Laboratory of Population Health Across Life Cycle(Anhui Medical University), Ministry of Education of the People's Republic of China

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Fangbiao Tao, M.D.

Role: CONTACT

Phone: 86-0551-13856986775

Email: [email protected]

Other Identifiers

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81250810

Identifier Type: -

Identifier Source: org_study_id