- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07712068
Effects of Exercise Sequence and Meal Sequence on Weight Management Among Children and Adolescents With Overweight or Obesity: The STEP Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xingbo Li, PhD
- Phone Number: 8618000315430
- Email: 2616394236@bjmu.edu.cn
Study Locations
-
-
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Beijing, China, 100083
- Peking University
-
Contact:
- Xingbo Li, PhD
- Phone Number: 8618000315430
- Email: 2616394236@bjmu.edu.cn
-
Beijing, China, 101499
- DF Fit Beijing Huairou
-
Contact:
- Xingbo Li, PhD
- Phone Number: 8618000315430
- Email: 2616394236@bjmu.edu.cn
-
-
Anhui
-
Wuhu, Anhui, China, 241303
- DF Fit Anhui Wuhu
-
Contact:
- Xingbo Li, PhD
- Phone Number: 8618000315430
- Email: 2616394236@bjmu.edu.cn
-
-
Henan
-
Zhengzhou, Henan, China, 451100
- DF Fit Henan Zhengzhou
-
Contact:
- Xingbo Li, PhD
- Phone Number: 8618000315430
- Email: 2616394236@bjmu.edu.cn
-
-
Liaoning
-
Shenyang, Liaoning, China, 110326
- DF Fit Liaoning Shenyang
-
Contact:
- Xingbo Li, PhD
- Phone Number: 8618000315430
- Email: 2616394236@bjmu.edu.cn
-
-
Shandong
-
Zibo, Shandong, China, 256402
- DF Fit Shandong Zibo
-
Contact:
- Xingbo Li, PhD
- Phone Number: 8618000315430
- Email: 2616394236@bjmu.edu.cn
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 201418
- DF Fit Shanghai Fengxian
-
Contact:
- Xingbo Li, PhD
- Phone Number: 8618000315430
- Email: 2616394236@bjmu.edu.cn
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 311256
- DF Fit Zhejiang Hangzhou
-
Contact:
- Xingbo Li, PhD
- Phone Number: 8618000315430
- Email: 2616394236@bjmu.edu.cn
-
Jinhua, Zhejiang, China, 321035
- DF Fit Zhejiang Jinhua
-
Contact:
- Xingbo Li, PhD
- Phone Number: 8618000315430
- Email: 2616394236@bjmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic first and usual eating
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.
|
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.
|
|
Experimental: Anaerobic first and usual eating
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.
|
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.
|
|
Experimental: Anaerobic first and carbohydrate-last eating
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.
|
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.
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.
|
|
Experimental: Aerobic first and carbohydrate-last eating
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight
Time Frame: From enrollment to the end of treatment at 28 days
|
Measures the body weight change in kg
|
From enrollment to the end of treatment at 28 days
|
|
Body fat
Time Frame: From enrollment to the end of treatment at 28 days
|
Changes in body fat percentage
|
From enrollment to the end of treatment at 28 days
|
|
HOMA-IR
Time Frame: From enrollment to the end of treatment at 28 days
|
Changs in HOMA-IR, or insulin resistance, in participants
|
From enrollment to the end of treatment at 28 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026131DFQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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