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Physical Activity and Gut Microbiota in Children (PA-Microbiome Kids)

NCT ID: NCT07310654

Last Updated: 2025-12-30

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

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-20

Study Completion Date

2026-06-30

Brief Summary

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This study evaluates the effect of a 16-week moderate-to-vigorous physical activity (MVPA) program on physical fitness and gut microbiota in healthy school-aged children. Participants will be randomly assigned to either an MVPA intervention group or an attention-control group. The primary outcome is the change in a composite physical fitness score. Secondary outcomes include changes in gut microbiota diversity and composition.

Detailed Description

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This is a two-arm, parallel-group, randomized controlled trial with 1:1 allocation. Healthy children aged 7-10 years will be recruited. The intervention group will receive a 16-week structured MVPA program (3 sessions/week, 45-60 min/session). The control group will receive attention-matched sedentary activities (e.g., reading, crafts) and will be offered the MVPA program after the trial (waitlist). Blinding will be applied to outcome assessors and laboratory/bioinformatics analysts. The primary analysis will follow the intention-to-treat (ITT) principle. The study aims to determine if the MVPA intervention improves physical fitness and modulates the gut microbiota, and to explore baseline microbiota features as potential modifiers of the intervention response.

Conditions

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Healthy

Keywords

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Physical Activity Gut Microbiota Microbiome Physical Fitness Children Health Promotion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants and intervention instructors are not blinded to group assignment. Outcome assessors (for physical fitness tests) and laboratory/bioinformatics personnel (for microbiota analysis) will be blinded to the allocation. The database will use codes (e.g., Group A/B) until primary analysis is complete.

Study Groups

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MVPA Program

Participants will engage in a 16-week structured moderate-to-vigorous physical activity (MVPA) program, 3 times per week, for 45-60 minutes per session. Sessions include warm-up, aerobic games, bodyweight strength circuits, and cool-down, supervised by trained instructors.

Group Type EXPERIMENTAL

16-week Structured MVPA Program

Intervention Type BEHAVIORAL

A 16-week structured moderate-to-vigorous physical activity program.

: Attention Control + Waitlist

Participants will engage in time-matched sedentary activities, such as reading, science experiments, or crafts, 3 times per week. They are instructed to maintain their usual physical activity levels. After the 16-week trial period, they will be offered a similar MVPA program.

Group Type ACTIVE_COMPARATOR

Attention Control Sedentary Activities

Intervention Type BEHAVIORAL

Time-matched sedentary activities such as reading, science experiments, or crafts.

Interventions

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16-week Structured MVPA Program

A 16-week structured moderate-to-vigorous physical activity program.

Intervention Type BEHAVIORAL

Attention Control Sedentary Activities

Time-matched sedentary activities such as reading, science experiments, or crafts.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participants from a previous cross-sectional study cohort conducted in August 2024, at which time they were 6-9 years old.
* Able to complete the 16-week follow-up.
* Guardian provides written informed consent, and the child provides assent.
* Medically cleared by a physician or school nurse to participate in moderate-intensity physical activity (no contraindications).
* No antibiotic use in the 4 weeks prior to baseline.
* No fever or acute gastroenteritis in the 2 weeks prior to baseline.
* Able to provide stool samples as required.

Exclusion Criteria

* Diagnosed with cardiopulmonary diseases, epilepsy, severe asthma, severe musculoskeletal disorders, or congenital heart disease.

* Recent acute exacerbation of chronic gastrointestinal diseases.
* Planning to follow a special diet (e.g., ketogenic, vegetarian) or requiring long-term prescription of antibiotics/probiotics.
* Planning to be absent for \>20% of the intervention period due to travel or other commitments.
* Enrolled in other high-intensity sports training programs that cannot be cancelled.
* Developmental or behavioral issues that would impede cooperation, as assessed by teachers and parents.
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aiyoudong Children and Youth Sports Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Pan Xiang

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aiyoudong Children and Youth Sports Health Research Institute

Weifang, Shandong, China

Site Status

Countries

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China

Central Contacts

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XIANG PAN

Role: CONTACT

Phone: 81+07085760989

Email: [email protected]

Facility Contacts

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XIANG PAN

Role: primary

Other Identifiers

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2244

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PA-Microbiome-Kids-2025

Identifier Type: -

Identifier Source: org_study_id