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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Aged 7-18 years at baseline.
At least one of the following cardio-metabolic abnormalities:
Written consent from participants and their guardians.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wennan He | Contact | +8664932921 | wennanhe@fudan.edu.cn | |
| Weili Yan | Contact | +8664931215 | yanwl@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 021 | China |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D002318 | Cardiovascular Diseases |
| D008659 | Metabolic Diseases |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| General health education | Behavioral | General instructions on promoting healthy diet and exercise, primarily by sending offline and online promotion materials to participants. |
|
| 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. | 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. | 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. | 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. | 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). | 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). | 3rd and 12th month since baseline |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |