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

Aiyoudong Children and Youth Sports Health Research Institute

Status: Not yet enrolling

Conditions: Healthy

Treatments: Behavioral: 16-week Structured MVPA Program; Behavioral: Attention Control Sedentary Activities

Study type: Interventional

Funder types: Other

Identifiers

NCT07310654

2244

PA-Microbiome-Kids-2025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 113 estimated patients

Sex: All

Ages: 7 to 11 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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113 participants in 2 patient groups

MVPA Program

Experimental group

Description:

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.

Treatment:

Behavioral: 16-week Structured MVPA Program

: Attention Control + Waitlist

Active Comparator group

Description:

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.

Treatment:

Behavioral: Attention Control Sedentary Activities