Cardiovascular Syndrome, MetabolicNCT06416488
High-Intensity Interval Training(HIIT) on Cardio-metabolic Risk in School-age Children
A study testing HIIT intervention and General health education in people with Cardiovascular Syndrome, Metabolic, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cardiovascular Syndrome, Metabolic
- What is being tested?
- HIIT intervention and General health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2024to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 021
Wennan He, postgraduate, 021-64932921, wennanhe@fudan.edu.cn
About this study
Official title: The Effect of High-Intensity Interval Training(HIIT) on Cardio-metabolic Indicators in School-age Children With High Cardiovascular Diseases Risk--a Randomised Intervention Trial
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.
Read the 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
- Being tested
- HIIT intervention, General health education
- Keywords
- Cardiovascular diseases, Metabolic disorders, High-Intensity Interval Training, School-aged children, Childhood obesity
- Medical subject headings
- Metabolic Syndrome, Cardiovascular Diseases, Metabolic Diseases, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT interventionBehavioural
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 educationBehavioural
General instructions on promoting healthy diet and exercise, primarily by sending offline and online promotion materials to participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: General health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure.
Measured: 3rd month since baseline
Secondary outcomes (7)
Number of participants with reversal of at least one cardio-metabolic abnormalities
It 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 12th month of study phrase.
Reversal of cardiometabolic abnormalities is defined as: at 12th month of study phrase, at least one of the following status changed from abnormal at baseline to normal:
- Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure.
Measured: 12th month since baseline
Body mass index
Body mass index(BMI) will be calculated by body weight(kg)/(height(m)^2), based on BMI z score and percentiles by sex and age according to Chinese children growth curves. Body weight and height will be measured by trained professionals.
Measured: 3rd and 12th month since baseline
Waist-to-height ratio
Waist-to-height ratio(WHtR) will be calculated by waist circumference(cm)/height(cm). Waist circumference and height will be measured by trained professionals.
Measured: 3rd and 12th month since baseline
Body fat (%)
Body fat(%) will be directly derived from non-invasive DEX body composition analyser, assessed by professional operator.
Measured: 3rd and 12th month since baseline
Resting metabolic rate
Average amount of calories(kcal) when at complete rest (2 hours after meals), measured by a Parvo Medics TrueOne 2400 mask to measure exchanges of gases.
Measured: 3rd and 12th month since baseline
Maximal oxygen uptake（ml/min/kg)
Maximal oxygen uptake(VO2max) will be measured by a Parvo Medics TrueOne 2400 mask after treadmill (Pulsar 4.0，h/p/Cosmos Sports and Medical GMBH , Germany).
Measured: 3rd and 12th month since baseline
Sleep quality
Sleep quality monitoring for 1 week using sleep watch （Micro Motionlogger Watch）to measure total duration of sleeping (minutes).
Measured: 3rd and 12th month since baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start13 Jul 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Syndrome, MetabolicStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416488
- Sponsor's protocol ID
- M-TABATA
- Status last verified
- Dec 2025
- First submitted
- 9 May 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-Intensity Interval Training(HIIT) on Cardio-metabolic Indicators in School-age Children With High Cardiovascular Diseases Risk--a Randomised Intervention Trial
- ClinicalTrials.gov ID
- NCT06416488
- Acronym / sponsor ID
- M-TABATA
- Conditions
- Cardiovascular Syndrome, Metabolic
- Keywords
- Cardiovascular diseases, Metabolic disorders, High-Intensity Interval Training, School-aged children, Childhood obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 13 Jul 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT group | Experimental | Behavioral: HIIT intervention, Behavioral: General health educationHIIT 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. |
| General health education group | Active comparator | Behavioral: General health educationGeneral 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Aged 7-18 years at baseline.
- At least one of the following cardio-metabolic abnormalities:
- Written consent from participants and their guardians.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT interventionModified 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. | Behavioural | HIIT group |
| General health educationGeneral instructions on promoting healthy diet and exercise, primarily by sending offline and online promotion materials to participants. | Behavioural | General health education group, HIIT group |
Primary outcome
Number of participants with reversal of at least one cardio-metabolic abnormalities
Time frame: 3rd month since baseline
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.
7 secondary outcomes
Number of participants with reversal of at least one cardio-metabolic abnormalities
Time frame: 12th month since baseline
Body mass index
Time frame: 3rd and 12th month since baseline
Waist-to-height ratio
Time frame: 3rd and 12th month since baseline
Body fat (%)
Time frame: 3rd and 12th month since baseline
Resting metabolic rate
Time frame: 3rd and 12th month since baseline
Maximal oxygen uptake（ml/min/kg)
Time frame: 3rd and 12th month since baseline
Sleep quality
Time frame: 3rd and 12th month since baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT intervention and General health education in people with Cardiovascular Syndrome, Metabolic, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wennan He (+8664932921, wennanhe@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with reversal of at least one cardio-metabolic abnormalities (time frame: 3rd month since baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.