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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-18
SponsorChildren's Hospital of Fudan University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 7-18 years at baseline.

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

336 Participants
are divided into 2 treatment groups
Group A: HIIT groupExperimental treatment 2 interventions
Group B: General health education groupActive comparator 1 intervention

Trial outcomes

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.

Time frame
3rd month since baseline

Secondary outcomes

1

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

Time frame
12th month since baseline
2

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.

Time frame
3rd and 12th month since baseline
3

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.

Time frame
3rd and 12th month since baseline
4

Body fat (%)

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

Time frame
3rd and 12th month since baseline

Other outcomes

Sponsors and contacts

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