Weight LossNCT06205563
The Therapeutic Effect of Different Exercise Intensities on Weight Loss in Obese Children
A study testing high-intensity interval training and moderate intensity continuous training in people with Weight Loss and Obese Children and Adolescents, run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial summary
The incidence of childhood obesity is increasing, followed by metabolic diseases related to overweight and obesity in children. High intensity interval training (HIIT) has recently been shown to improve the body composition and cardiovascular health of obese children. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Weight Loss, Obese Children and Adolescents
- What is being tested?
- high-intensity interval training and moderate intensity continuous training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Dec 2026
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The guardian understands and signs the informed consent. If the subject is at least 8 years old, the informed consent must be signed.
- Age 6~16 years old, male and female;
- BMI≥ \"sex-age BMI reference point for obesity screening of school-age children aged 6-18 years\";
- no disability;
- Joint cardiopulmonary function assessment showed that participation was safe;
- At least one year of follow-up is expected.
Who cannot join
- Have high blood pressure (defined as systolic or diastolic blood pressure values above the 95th percentile), any history or evidence of heart disease and/or abnormal resting or stress echocardiography or a combined cardiopulmonary function assessment indicating that participation is not safe;
- have any chronic disease, such as chronic asthma, kidney disease, type 1 diabetes, epilepsy, etc.;
- suffering from organic diseases, such as ovarian tumors, hamartoma, etc.;
- A smoking habit or orthopedic/neurological condition that may limit exercise ability;
- Confirmed attention deficit hyperactivity disorder and steroid use.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of Short-term Supervised High-intensity Interval Training and Moderate Intensity Continuous Training on Weight Loss and Metabolic Indicators in Obese Children Under Energy Limited Balanced Diet
The incidence of childhood obesity is increasing, followed by metabolic diseases related to overweight and obesity in children. High intensity interval training (HIIT) has recently been shown to improve the body composition and cardiovascular health of obese children. Currently, there is little evidence on the impact of exercise intensity on endocrine and metabolic indicators and quality of life in obese children.
The main purpose of this study is to compare the effects of short-term supervised high-intensity interval training and moderate intensity continuous training (MICT) on metabolic indicators in obese children under an energy limited balanced diet. A multicenter prospective randomized controlled trial was conducted on 388 obese children in South China. The experimental group will be randomly assigned to (1) HIIT and energy limited balanced diet, and (2) MICT and energy limited balanced diet. The experimental group will participate in a 3-month (supervised) exercise training. The measurement of the study endpoint will be followed up at baseline, 3 months (after supervised intervention), 9 months, and 1 year. The primary endpoint is the percentage of weight loss (△ Wt%). Secondary endpoints include waist to height ratio, body mass index (BMI), body fat percentage, insulin resistance index (HOMA-IR), insulin secretion index (ISI), and Δ HtSDSBA. The results of this study will generate a wealth of information on the impact of exercise intensity on weight loss and endocrine metabolism in obese children, and develop more effective evidence-based exercise prescription guidelines in this population.
- Conditions
- Weight Loss, Obese Children and Adolescents
- Being tested
- high-intensity interval training, moderate intensity continuous training
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity interval trainingBehavioural
High-intensity interval training (to significantly faster breathing, a significant increase in breathing depth, a significant increase in heart rate, sweating, and the need to stop exercising and adjust your breathing before you can speak; Energy expenditure (METy ≥6.00 in children) : Participants randomly assigned to HIIT will perform a 10-minute warm-up at 60-70% of their maximum heart rate (HRmax). After this, they will walk, run, or bike at 85-95% of their maximum heart rate for four sessions of four minutes each, with three minutes of active recovery (50-70% of their maximum heart rate) in between. The participants were given a five-minute cooling-off period at the end, for a total of 40 minutes of exercise. Participants will be required to participate in supervised exercise classes at least five times and up to seven times a week for 12 weeks. Each participant will be free to wear a smart electronic sports bracelet, which can be used to punch in sports.
moderate intensity continuous trainingBehavioural
Moderate intensity continuous training (rapid breathing, rapid heart rate, slight sweating, but still able to talk easily; Energy expenditure (children METy) 3.00 to 5.99) : Participants randomly assigned to the MICT group will walk, run, or cycle continuously for 40 minutes at 60-70% HRmax. Participants will be required to participate in supervised exercise classes at least five times and up to seven times a week for 12 weeks. Each participant will be free to wear a smart electronic sports bracelet, which can be used to punch in sports.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Behavioral: high-intensity interval training |
| Arm B | Active comparator | Not described Receives: Behavioral: moderate intensity continuous training |
What is being measured
The primary outcome is the main question the study is designed to answer.
△Wt%
Percentage of weight loss (△Wt%) = (weight at week n - weight at week 0)/weight at week 0 *100%
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Shunye, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205563
- Sponsor's protocol ID
- TOWL
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Short-term Supervised High-intensity Interval Training and Moderate Intensity Continuous Training on Weight Loss and Metabolic Indicators in Obese Children Under Energy Limited Balanced Diet
- ClinicalTrials.gov ID
- NCT06205563
- Acronym / sponsor ID
- TOWL
- Conditions
- Weight Loss, Obese Children and Adolescents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Jan 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.
The incidence of childhood obesity is increasing, followed by metabolic diseases related to overweight and obesity in children. High intensity interval training (HIIT) has recently been shown to improve the body composition and cardiovascular health of obese children. Currently, there is little evidence on the impact of exercise intensity on endocrine and metabolic indicators and quality of life in obese children.
The main purpose of this study is to compare the effects of short-term supervised high-intensity interval training and moderate intensity continuous training (MICT) on metabolic indicators in obese children under an energy limited balanced diet. A multicenter prospective randomized controlled trial was conducted on 388 obese children in South China. The experimental group will be randomly assigned to (1) HIIT and energy limited balanced diet, and (2) MICT and energy limited balanced diet. The experimental group will participate in a 3-month (supervised) exercise training. The measurement of the study endpoint will be followed up at baseline, 3 months (after supervised intervention), 9 months, and 1 year. The primary endpoint is the percentage of weight loss (△ Wt%). Secondary endpoints include waist to height ratio, body mass index (BMI), body fat percentage, insulin resistance index (HOMA-IR), insulin secretion index (ISI), and Δ HtSDSBA. The results of this study will generate a wealth of information on the impact of exercise intensity on weight loss and endocrine metabolism in obese children, and develop more effective evidence-based exercise prescription guidelines in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Behavioral: high-intensity interval training |
| Arm B | Active comparator | Behavioral: moderate intensity continuous training |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The guardian understands and signs the informed consent. If the subject is at least 8 years old, the informed consent must be signed.
- Age 6~16 years old, male and female;
- BMI≥ \"sex-age BMI reference point for obesity screening of school-age children aged 6-18 years\";
- no disability;
- Joint cardiopulmonary function assessment showed that participation was safe;
Key exclusion criteria (5 listed)
- Have high blood pressure (defined as systolic or diastolic blood pressure values above the 95th percentile), any history or evidence of heart disease and/or abnormal resting or stress echocardiography or a combined cardiopulmonary function assessment indicating that participation is not safe;
- have any chronic disease, such as chronic asthma, kidney disease, type 1 diabetes, epilepsy, etc.;
- suffering from organic diseases, such as ovarian tumors, hamartoma, etc.;
- A smoking habit or orthopedic/neurological condition that may limit exercise ability;
- Confirmed attention deficit hyperactivity disorder and steroid use.
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 |
|---|---|---|
| high-intensity interval trainingHigh-intensity interval training (to significantly faster breathing, a significant increase in breathing depth, a significant increase in heart rate, sweating, and the need to stop exercising and adjust your breathing before you can speak; Energy expenditure (METy ≥6.00 in children) : Participants randomly assigned to HIIT will perform a 10-minute warm-up at 60-70% of their maximum heart rate (HRmax). After this, they will walk, run, or bike at 85-95% of their maximum heart rate for four sessions of four minutes each, with three minutes of active recovery (50-70% of their maximum heart rate) in between. The participants were given a five-minute cooling-off period at the end, for a total of 40 minutes of exercise. Participants will be required to participate in supervised exercise classes at least five times and up to seven times a week for 12 weeks. Each participant will be free to wear a smart electronic sports bracelet, which can be used to punch in sports. | Behavioural | Arm A |
| moderate intensity continuous trainingModerate intensity continuous training (rapid breathing, rapid heart rate, slight sweating, but still able to talk easily; Energy expenditure (children METy) 3.00 to 5.99) : Participants randomly assigned to the MICT group will walk, run, or cycle continuously for 40 minutes at 60-70% HRmax. Participants will be required to participate in supervised exercise classes at least five times and up to seven times a week for 12 weeks. Each participant will be free to wear a smart electronic sports bracelet, which can be used to punch in sports. | Behavioural | Arm B |
Primary outcome
△Wt%
Time frame: From enrollment to the end of treatment at 12 weeks
Percentage of weight loss (△Wt%) = (weight at week n - weight at week 0)/weight at week 0 *100%
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 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing high-intensity interval training and moderate intensity continuous training in people with Weight Loss and Obese Children and Adolescents, run by Third Affiliated Hospital, Sun Yat-Sen University.
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 5 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: opening soon, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Juan Lin (800-555-5555, linj89@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
△Wt% (time frame: From enrollment to the end of treatment at 12 weeks). 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 Jan 2024.