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

NCT06416488 | Recruiting

• 1 other identifier: M-TABATA
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Syndrome, Metabolic

Keywords

Cardiovascular diseases; Metabolic disorders; High-Intensity Interval Training; School-aged children; Childhood obesity

Outcome Measures

Primary Outcomes (1)

• Number of participants with reversal of at least one cardio-metabolic abnormalities

  The primary outcome is a composite outcome that will be measured by combining multiple reverse outcomes of the following cardiometabolic abnormalities: (1) prediabetes; (2) lipid abnormalities; (3) elevated blood pressure. It is defined as occurring if any cardiometabolic abnormality has a reversal outcome at 3rd month of study phrase. Reversal of cardiometabolic abnormalities is defined as: at 3rd month of study phrase, at least one of the following status changed from abnormal at baseline to normal: i. Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure.

  3rd month since baseline

Secondary Outcomes (7)

• Number of participants with reversal of at least one cardio-metabolic abnormalities

  12th month since baseline

• Body mass index

  3rd and 12th month since baseline

• Waist-to-height ratio

  3rd and 12th month since baseline

• Body fat (%)

  3rd and 12th month since baseline

• Resting metabolic rate

  3rd and 12th month since baseline

Study Arms (2)

HIIT group

EXPERIMENTAL

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.

Behavioral: HIIT intervention; Behavioral: General health education

General health education group

ACTIVE COMPARATOR

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.

Behavioral: General health education

Interventions

HIIT intervention 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.

HIIT group

General health education BEHAVIORAL

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

General health education group; HIIT group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 021, China

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases; Metabolic Diseases; Pediatric Obesity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wennan He

CONTACT

+8664932921; wennanhe@fudan.edu.cn

Weili Yan

CONTACT

+8664931215; yanwl@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 16, 2024
• Study Start: July 13, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)