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NCT Number: NCT06416488

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

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.

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 021, China

Location status: Recruiting

Location contact

Wennan He, postgraduate

CONTACT

[email protected]

021-64932921

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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.

General health education

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 12th month since baseline

    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:

    i. Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure.

  2. Body mass index

    Time frame: 3rd and 12th month since baseline

    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.

  3. Waist-to-height ratio

    Time frame: 3rd and 12th month since baseline

    Waist-to-height ratio(WHtR) will be calculated by waist circumference(cm)/height(cm). Waist circumference and height will be measured by trained professionals.

  4. Body fat (%)

    Time frame: 3rd and 12th month since baseline

    Body fat(%) will be directly derived from non-invasive DEX body composition analyser, assessed by professional operator.

  5. Resting metabolic rate

    Time frame: 3rd and 12th month since baseline

    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.

  6. Maximal oxygen uptake(ml/min/kg)

    Time frame: 3rd and 12th month since baseline

    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).

  7. Sleep quality

    Time frame: 3rd and 12th month since baseline

    Sleep quality monitoring for 1 week using sleep watch (Micro Motionlogger Watch)to measure total duration of sleeping (minutes).

Study contacts

Contact information is provided by the study sponsor or research team.

Weili Yan

CONTACT

[email protected]

+8664931215

Wennan He

CONTACT

[email protected]

+8664932921

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 16, 2024
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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