High-Intensity Interval Training(HIIT) on Cardio-metabolic Risk in School-age Children

NCT ID: NCT06416488

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-13
• Study Completion Date: 2028-09-30

Brief Summary

This study aims to evaluate the health promotion effects of high-intensity interval training (HIIT) intervention on school-age children who are at high risk for cardiovascular disease (CVD), as well as the long-term adherence and acceptability of HIIT in this population for future application.

Detailed Description

Evidence shows that physical activity is positively associated with cardiovascular and metabolic health in children and adolescents, including promoting lipid health, regulating blood pressure levels, and glucose metabolism. Physical activity intervention for overweight or obese children can lower body mass index, total fat mass, and abdominal fat mass, and further prevent chronic diseases such as cardiovascular and metabolic diseases. High-intensity interval training (HIIT) has been a recent research focus. Previous studies have demonstrated that HIIT can contribute to improving body composition, reducing visceral fat, and enhancing cardiovascular and pulmonary function. Moreover, compared to other trainings, HIIT is time-efficient and adaptable to various sports, thus leading to higher compliance.

However, there has been a lack of evidence regarding the intervention effects of this exercise in overweight and obese children and adolescents, and whether it can impact or even reverse cardio-metabolic risks remains unknown.

Therefore, this intervention trial might have implications and practical significance on the feasibility of promoting HIIT among this population.

Conditions

Cardiovascular Syndrome, Metabolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HIIT group

HIIT group will follow modified HIIT in Tabata mode, at least 3 times per week, with 3-month compulsory period and 9-month follow-up period. General health education on promoting health diet and exercise will be sent to HIIT group via offline and online promotion materials during the whole study period of 12 months.

Group Type: EXPERIMENTAL

HIIT intervention

Intervention Type: BEHAVIORAL

Modified HIIT in Tabata mode, which followed a pattern of 3 sets, with each set consisting of 4 repetitions of 20 seconds of high-intensity exercise followed by 10 seconds of rest, at least 3 times per week.

General health education

Intervention Type: BEHAVIORAL

General instructions on promoting healthy diet and exercise, primarily by sending offline and online promotion materials to participants.

General health education group

General health education on promoting health diet and exercise will be sent to general health education group via offline and online promotion materials during the whole study period of 12 months.

Group Type: ACTIVE_COMPARATOR

General health education

Intervention Type: BEHAVIORAL

General instructions on promoting healthy diet and exercise, primarily by sending offline and online promotion materials to participants.

Interventions

HIIT intervention

Modified HIIT in Tabata mode, which followed a pattern of 3 sets, with each set consisting of 4 repetitions of 20 seconds of high-intensity exercise followed by 10 seconds of rest, at least 3 times per week.

Intervention Type: BEHAVIORAL

General health education

General instructions on promoting healthy diet and exercise, primarily by sending offline and online promotion materials to participants.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 7-18 years at baseline.
• At least one of the following cardio-metabolic abnormalities:

1. Prediabetes (Impaired fasting glucose: 5.6 ≤ fasting blood glucose level ≤ 6.9 mmol/L; or Impaired glucose tolerance: 7.8 ≤ blood glucose level after 2 hours postprandial ≤ 11.0 mmol/L).

2. Lipid abnormalities (High-density lipoprotein cholesterol ≤ 1.04 mmol/L; or Low-density lipoprotein cholesterol ≥ 3.37 mmol/L; or Triglycerides ≥ 1.70 mmol/L, or Total cholesterol ≥ 5.18 mmol/L).

3. Elevated blood pressure (Systolic/diastolic blood pressure consistently higher than the 90th percentile for gender, age, and height; or systolic/diastolic blood pressure ≥ 120/80 mmHg).

• Written consent from participants and their guardians.

Exclusion Criteria

• Previously diagnosed with heart failure, severe malnutrition, immune deficiency, liver or kidney disease, cancer, or other diseases deemed unsuitable for participation.
• Taking weight loss drugs, or undergone weight loss surgery.
• Attending behavior-based intervention programs (exercise or diet) within a year.
• Regular HIIT (at least once per week).
• Secondary obesity, such as neuropsychiatric disorders, endocrine disorders, sleep apnea syndrome, or other conditions.
• Unable to take interventions due to health conditions, such as joint diseases, fractures, injuries.
• Other situations unsuitable for participation.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wennan He

Role: CONTACT

wennanhe@fudan.edu.cn

+8664932921

Weili Yan

Role: CONTACT

yanwl@fudan.edu.cn

+8664931215

Facility Contacts

Wennan He, postgraduate

Role: primary

wennanhe@fudan.edu.cn

021-64932921

Other Identifiers

M-TABATA

Identifier Type: -

Identifier Source: org_study_id