Obesity & OverweightNCT07712068
Effects of Exercise Sequence and Meal Sequence on Weight Management Among Children and Adolescents With Overweight or Obesity: The STEP Trial
A study testing Carbohydrate-last eating and Sequential training in people with Obesity & Overweight and Insulin Resistance, run by Peking University at 9 sites in China.
Trial summary
The goal of this clinical trial is to learn how the order of exercise and the order of eating food affect weight management in overweight and obese children and adolescents. The main questions it aims to answer are whether doing aerobic or anaerobic exercise first changes weight loss results, and whether eating… Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Insulin Resistance, Inflamation
- What is being tested?
- Carbohydrate-last eating and Sequential training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 9 sitesChina
- Study dates
- Jul 2026to 30 Sep 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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- To be included in the study, participants must be between 10 and 17 years old and have a Body Mass Index equal to or greater than the 95th percentile for their age and sex, which meets the Chinese screening standard for overweight and obesity in school-aged children and adolescents. Additionally, participants and their legal guardians must have signed a service contract and paid in full for the commercial weight loss camp service before signing the study consent form. Participants must possess basic communication skills and the ability to comply with study instructions. They must also pass the mandatory pre-camp exercise risk medical screening, which includes blood and urine tests, blood pressure, resting electrocardiograms, and exercise electrocardiograms. Finally, participants and their legal guardians must provide dual signed informed consent.
Who cannot join
- Individuals are excluded from the study if they have been diagnosed with secondary obesity or genetic obesity syndromes. Furthermore, individuals who have taken medications affecting body weight or bone metabolism within the past three months are not eligible to participate. The study also excludes individuals with clinically diagnosed eating disorders, depression, or other severe psychiatric illnesses. Individuals who are unable or unwilling to cooperate with venous blood sampling or other biological sample collections are excluded as well. Finally, individuals with severe cardiopulmonary dysfunction, severe scoliosis, or other clear medical contraindications to exercise cannot participate in the trial.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites
Peking University
Beijing, 100083
Xingbo Li, PhD, 8618000315430, 2616394236@bjmu.edu.cn
DF Fit Beijing Huairou
Beijing, 101499
Xingbo Li, PhD, 8618000315430, 2616394236@bjmu.edu.cn
DF Fit Zhejiang Hangzhou
Hangzhou, Zhejiang, 311256
Xingbo Li, PhD, 8618000315430, 2616394236@bjmu.edu.cn
DF Fit Zhejiang Jinhua
Jinhua, Zhejiang, 321035
Xingbo Li, PhD, 8618000315430, 2616394236@bjmu.edu.cn
DF Fit Shanghai Fengxian
Shanghai, Shanghai Municipality, 201418
Xingbo Li, PhD, 8618000315430, 2616394236@bjmu.edu.cn
DF Fit Liaoning Shenyang
Shenyang, Liaoning, 110326
Xingbo Li, PhD, 8618000315430, 2616394236@bjmu.edu.cn
DF Fit Anhui Wuhu
Wuhu, Anhui, 241303
Xingbo Li, PhD, 8618000315430, 2616394236@bjmu.edu.cn
DF Fit Henan Zhengzhou
Zhengzhou, Henan, 451100
Xingbo Li, PhD, 8618000315430, 2616394236@bjmu.edu.cn
DF Fit Shandong Zibo
Zibo, Shandong, 256402
Xingbo Li, PhD, 8618000315430, 2616394236@bjmu.edu.cn
About this study
The goal of this clinical trial is to learn how the order of exercise and the order of eating food affect weight management in overweight and obese children and adolescents. The main questions it aims to answer are whether doing aerobic or anaerobic exercise first changes weight loss results, and whether eating vegetables and proteins before carbohydrates improves health outcomes compared to a standard diet. Furthermore, the study asks how the exercise order and eating order work together to affect weight and health. Researchers will compare four different groups to see if these specific exercise and eating orders work better to treat obesity. Participants will stay at a closed weight loss camp for 28 days and do daily aerobic and anaerobic exercises in a randomly assigned order. They will eat meals in either a strict order, consuming vegetables and proteins first, or a standard order. Throughout the trial, participants will give blood, urine, stool, saliva, and sweat samples for lab tests, while also checking their body weight, body composition, and heart rate. Finally, they will answer surveys about their diet, physical activity, hunger, and tiredness.
- Conditions
- Obesity & Overweight, Insulin Resistance, Inflamation
- Being tested
- Carbohydrate-last eating, Sequential training
- Keywords
- child and adolescent obesity, obesity & overweight, child and adolescent insulin resistance
- Medical subject headings
- Obesity, Overweight, Insulin Resistance, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate-last eatingBehavioural
This intervention requires participants to eat each meal in sequencial order. They will eat half to two-thirds of all vegetables and meat/protein foods, and then start eating carbohydrate such as starchy tubers or staple foods to finish their meal.
Sequential trainingBehavioural
This intervention requires participants to follow each structured training session with designated sequence of physical activity. Participants will either follow aerobic training first and anaerobic training second within each session, or vice versa.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic first and usual eating | Experimental | In this arm, participants will follow each of their training sessions by starting with warm up, then aerobic training, followed by anaerobic training, and lastly stretching and relaxation. For each meal, participants will be offered all food and can eat ad libitum. Receives: Behavioral: Sequential training |
| Anaerobic first and usual eating | Experimental | In this arm, participants will follow each of their training sessions by starting with warm up, then anaerobic training, followed by aerobic training, and lastly stretching and relaxation. For each meal, participants will be offered all food and can eat ad libitum. Receives: Behavioral: Sequential training |
| Anaerobic first and carbohydrate-last eating | Experimental | In this arm, participants will follow each of their training sessions by starting with warm up, then anaerobic training, followed by aerobic training, and lastly stretching and relaxation. They will eat half to two-thirds of all vegetables and meat/protein foods, and then start eating carbohydrate such as starchy tubers or staple foods to finish their meal. Receives: Behavioral: Carbohydrate-last eating; Behavioral: Sequential training |
| Aerobic first and carbohydrate-last eating | Experimental | In this arm, participants will follow each of their training sessions by starting with warm up, then aerobic training, followed by anaerobic training, and lastly stretching and relaxation. They will eat half to two-thirds of all vegetables and meat/protein foods, and then start eating carbohydrate such as starchy tubers or staple foods to finish their meal. Receives: Behavioral: Carbohydrate-last eating; Behavioral: Sequential training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measures the body weight change in kg
Measured: From enrollment to the end of treatment at 28 days
Body fat
Changes in body fat percentage
Measured: From enrollment to the end of treatment at 28 days
HOMA-IR
Changs in HOMA-IR, or insulin resistance, in participants
Measured: From enrollment to the end of treatment at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startJul 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Factorial
- Model description
- This study uses a multi-center, 2x2 factorial cluster randomized controlled trial design. Participants are assigned to one of four groups based on two behavioral interventions involving exercise sequence and meal sequence. The exercise sequence intervention compares doing aerobic training first versus anaerobic training first. The meal sequence intervention compares a structured, sequential eating order that involves consuming vegetables and proteins before carbohydrates versus a standard, ad libitum eating order. The four resulting study arms are Aerobic First with ad libitum Diet, Anaerobic First with ad libitum Diet, Aerobic First with Sequential Diet, and Anaerobic First with Sequential Diet.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712068
- Sponsor's protocol ID
- 2026131DFQ
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Sequence and Meal Sequence on Weight Management Among Children and Adolescents With Overweight or Obesity: The STEP Trial
- ClinicalTrials.gov ID
- NCT07712068
- Acronym / sponsor ID
- 2026131DFQ
- Conditions
- Obesity & Overweight, Insulin Resistance, Inflamation
- Keywords
- child and adolescent obesity, obesity & overweight, child and adolescent insulin resistance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 17 Jul 2026 (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 goal of this clinical trial is to learn how the order of exercise and the order of eating food affect weight management in overweight and obese children and adolescents. The main questions it aims to answer are whether doing aerobic or anaerobic exercise first changes weight loss results, and whether eating vegetables and proteins before carbohydrates improves health outcomes compared to a standard diet. Furthermore, the study asks how the exercise order and eating order work together to affect weight and health. Researchers will compare four different groups to see if these specific exercise and eating orders work better to treat obesity. Participants will stay at a closed weight loss camp for 28 days and do daily aerobic and anaerobic exercises in a randomly assigned order. They will eat meals in either a strict order, consuming vegetables and proteins first, or a standard order. Throughout the trial, participants will give blood, urine, stool, saliva, and sweat samples for lab tests, while also checking their body weight, body composition, and heart rate. Finally, they will answer surveys about their diet, physical activity, hunger, and tiredness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This study uses a multi-center, 2x2 factorial cluster randomized controlled trial design. Participants are assigned to one of four groups based on two behavioral interventions involving exercise sequence and meal sequence. The exercise sequence intervention compares doing aerobic training first versus anaerobic training first. The meal sequence intervention compares a structured, sequential eating order that involves consuming vegetables and proteins before carbohydrates versus a standard, ad libitum eating order. The four resulting study arms are Aerobic First with ad libitum Diet, Anaerobic First with ad libitum Diet, Aerobic First with Sequential Diet, and Anaerobic First with Sequential Diet.
| Arm | Type | Receives |
|---|---|---|
| Aerobic first and usual eating | Experimental | Behavioral: Sequential trainingIn this arm, participants will follow each of their training sessions by starting with warm up, then aerobic training, followed by anaerobic training, and lastly stretching and relaxation. For each meal, participants will be offered all food and can eat ad libitum. |
| Anaerobic first and usual eating | Experimental | Behavioral: Sequential trainingIn this arm, participants will follow each of their training sessions by starting with warm up, then anaerobic training, followed by aerobic training, and lastly stretching and relaxation. For each meal, participants will be offered all food and can eat ad libitum. |
| Anaerobic first and carbohydrate-last eating | Experimental | Behavioral: Carbohydrate-last eating, Behavioral: Sequential trainingIn this arm, participants will follow each of their training sessions by starting with warm up, then anaerobic training, followed by aerobic training, and lastly stretching and relaxation. They will eat half to two-thirds of all vegetables and meat/protein foods, and then start eating carbohydrate such as starchy tubers or staple foods to finish their meal. |
| Aerobic first and carbohydrate-last eating | Experimental | Behavioral: Carbohydrate-last eating, Behavioral: Sequential trainingIn this arm, participants will follow each of their training sessions by starting with warm up, then aerobic training, followed by anaerobic training, and lastly stretching and relaxation. They will eat half to two-thirds of all vegetables and meat/protein foods, and then start eating carbohydrate such as starchy tubers or staple foods to finish their meal. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- To be included in the study, participants must be between 10 and 17 years old and have a Body Mass Index equal to or greater than the 95th percentile for their age and sex, which meets the Chinese screening standard for overweight and obesity in school-aged children and adolescents. Additionally, participants and their legal guardians must have signed a service contract and paid in full for the commercial weight loss camp service before signing the study consent form. Participants must possess basic communication skills and the ability to comply with study instructions. They must also pass the mandatory pre-camp exercise risk medical screening, which includes blood and urine tests, blood pressure, resting electrocardiograms, and exercise electrocardiograms. Finally, participants and their legal guardians must provide dual signed informed consent.
Key exclusion criteria (1 listed)
- Individuals are excluded from the study if they have been diagnosed with secondary obesity or genetic obesity syndromes. Furthermore, individuals who have taken medications affecting body weight or bone metabolism within the past three months are not eligible to participate. The study also excludes individuals with clinically diagnosed eating disorders, depression, or other severe psychiatric illnesses. Individuals who are unable or unwilling to cooperate with venous blood sampling or other biological sample collections are excluded as well. Finally, individuals with severe cardiopulmonary dysfunction, severe scoliosis, or other clear medical contraindications to exercise cannot participate in the trial.
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 |
|---|---|---|
| Carbohydrate-last eatingThis intervention requires participants to eat each meal in sequencial order. They will eat half to two-thirds of all vegetables and meat/protein foods, and then start eating carbohydrate such as starchy tubers or staple foods to finish their meal. | Behavioural | Aerobic first and carbohydrate-last eating, Anaerobic first and carbohydrate-last eating |
| Sequential trainingThis intervention requires participants to follow each structured training session with designated sequence of physical activity. Participants will either follow aerobic training first and anaerobic training second within each session, or vice versa. | Behavioural | Aerobic first and carbohydrate-last eating, Aerobic first and usual eating, Anaerobic first and carbohydrate-last eating, Anaerobic first and usual eating |
Primary outcome
Weight
Time frame: From enrollment to the end of treatment at 28 days
Measures the body weight change in kg
Body fat
Time frame: From enrollment to the end of treatment at 28 days
Changes in body fat percentage
HOMA-IR
Time frame: From enrollment to the end of treatment at 28 days
Changs in HOMA-IR, or insulin resistance, in participants
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 17 Jul 2026.
- Individual participant dataSharing planned: Yes
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate-last eating and Sequential training in people with Obesity & Overweight and Insulin Resistance, run by Peking University at 9 sites in China.
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 1 inclusion and 1 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Xingbo Li, PhD (8618000315430, 2616394236@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: From enrollment to the end of treatment at 28 days). The study lists 3 primary outcomes in all. 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 17 Jul 2026.