## Protocol Section
### Identification Module
**NCT ID:** NCT06416488

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

**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

#### Organization Study ID Info
**ID:** M-TABATA
#### Organization
**Class:** OTHER
**Full Name:** Children's Hospital of Fudan University
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Children's Hospital of Fudan University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Cardiovascular Syndrome, Metabolic

**Keywords:**

- Cardiovascular diseases

- Metabolic disorders

- High-Intensity Interval Training

- School-aged children

- Childhood obesity

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 336

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: HIIT intervention

- Behavioral: General health education

**Label:** HIIT group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: General health education

**Label:** General health education group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HIIT group

**Description:** 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.

**Name:** HIIT intervention

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- General health education group

- HIIT group

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

**Name:** General health education

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Number of participants with reversal of at least one cardio-metabolic abnormalities

**Time Frame:** 3rd month since baseline

#### Secondary Outcomes

**Description:** 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.

**Measure:** Number of participants with reversal of at least one cardio-metabolic abnormalities

**Time Frame:** 12th month since baseline

**Description:** 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.

**Measure:** Body mass index

**Time Frame:** 3rd and 12th month since baseline

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

**Measure:** Waist-to-height ratio

**Time Frame:** 3rd and 12th month since baseline

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

**Measure:** Body fat (%)

**Time Frame:** 3rd and 12th month since baseline

**Description:** 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.

**Measure:** Resting metabolic rate

**Time Frame:** 3rd and 12th month since baseline

**Description:** 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).

**Measure:** Maximal oxygen uptake（ml/min/kg)

**Time Frame:** 3rd and 12th month since baseline

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

**Measure:** Sleep quality

**Time Frame:** 3rd and 12th month since baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

  1. 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).
  2. 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).
  3. 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.

**Maximum Age:** 18 Years

**Minimum Age:** 7 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wennanhe@fudan.edu.cn

**Name:** Wennan He

**Phone:** +8664932921

**Role:** CONTACT

**Contact 2:**

**Email:** yanwl@fudan.edu.cn

**Name:** Weili Yan

**Phone:** +8664931215

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007333

- Term: Insulin Resistance

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M30155

- Name: Pediatric Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M23005

- Name: Metabolic Syndrome

- Relevance: HIGH

- As Found: Cardiovascular Syndromes, Metabolic

- ID: M10370

- Name: Insulin Resistance

- Relevance: LOW

- As Found: Unknown

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000024821

- Term: Metabolic Syndrome

### Misc Info Module

- Version Holder: 2024-05-31
