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

NCT07310654 | Completed

• 2 other identifiers: PA-Microbiome-Kids-20252244
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Physical Activity; Gut Microbiota; Microbiome; Physical Fitness; Children; Health Promotion

Outcome Measures

Primary Outcomes (1)

• Change in Composite Physical Fitness Z-score

  Change from Baseline to 16 weeks in a composite physical fitness z-score. The score is calculated based on the age-appropriate items and weighting from the "National Student Physical Health Standard (2014 Revision)". The scale is a standardized z-score with a mean of 0 and a standard deviation of 1, based on a reference population. There are no theoretical upper or lower limits, but values typically range from -3 to +3. A higher score indicates better overall physical fitness.

  Baseline and 16 weeks

Secondary Outcomes (5)

• Change in Gut Microbiota Alpha Diversity

  Baseline and 16 weeks

• Difference in Gut Microbiota Beta Diversity

  Baseline and 16 weeks

• Change in Body Mass Index (BMI) Z-score

  Baseline and 16 weeks

• Heterogeneity of Treatment Effect Across Baseline PA×PF Quadrants

  Baseline and 16 weeks

• Baseline Microbial Taxa as Effect Modifiers of Intervention Response

  Baseline and 16 weeks

Other Outcomes (22)

• Change in Body Fat Percentage

  Baseline and 16 weeks

• Change in Waist Circumference and Waist-to-Hip Ratio

  Baseline and 16 weeks

• Change in Resting Heart Rate

  Baseline and 16 weeks

Study Arms (2)

MVPA Program

EXPERIMENTAL

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.

Behavioral: 16-week Structured MVPA Program

Attention Control + Waitlist

OTHER

Participants engage in time-matched sedentary activities such as reading, science experiments, or crafts, three times per week, and are instructed to maintain their usual physical activity levels. After the 16-week trial period, they are offered a comparable MVPA program (waitlist).

Behavioral: Attention Control Sedentary Activities

Interventions

16-week Structured MVPA Program BEHAVIORAL

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

MVPA Program

Attention Control Sedentary Activities BEHAVIORAL

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

Attention Control + Waitlist

Eligibility Criteria

• Age: 7 Years - 11 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants from a previous cross-sectional study cohort conducted in 2023 (Pan et al., Sci Rep 2025;15:21351), 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aiyoudong Children and Youth Sports Health Research Institute: lead

Study Sites (1)

Aiyoudong Children and Youth Sports Health Research Institute

Weifang, Shandong, 261000, China

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a PROBE-design trial (Prospective, Randomized, Open-label, Blinded Endpoint). Participants and intervention instructors are not blinded to group assignment, as blinding is not feasible for a behavioral physical activity intervention. Outcome assessors conducting physical fitness tests, and laboratory and bioinformatics personnel analyzing the gut microbiota, are blinded to participant allocation. The trial database uses coded group labels (Group A / Group B) throughout data collection and analysis, with unblinding only after the primary analysis is complete.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 30, 2025
• Study Start: December 31, 2025
• Primary Completion: April 22, 2026
• Study Completion: May 31, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available starting 12 months after publication of the primary outcomes manuscript, with no end date.
• Access Criteria: Data will be publicly accessible via the Genome Sequence Archive (https://ngdc.cncb.ac.cn/gsa-human) for sequencing data. Phenotypic data will be available upon reasonable request to the corresponding author, subject to a data use agreement and approval by the CISS Ethics Committee.

Locations

CN (1)