Effects of Exercise Sequence and Meal Sequence on Weight Management Among Children and Adolescents With Overweight or Obesity: The STEP Trial

NCT07712068 | Not Yet Recruiting

• 1 other identifier: 2026131DFQ
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 9

Brief 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 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

Keywords

child and adolescent obesity; obesity & overweight; child and adolescent insulin resistance

Outcome Measures

Primary Outcomes (3)

• Weight

  Measures the body weight change in kg

  From enrollment to the end of treatment at 28 days

• Body fat

  Changes in body fat percentage

  From enrollment to the end of treatment at 28 days

• HOMA-IR

  Changs in HOMA-IR, or insulin resistance, in participants

  From enrollment to the end of treatment at 28 days

Study Arms (4)

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.

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.

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.

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.

Behavioral: Carbohydrate-last eating; Behavioral: Sequential training

Interventions

Carbohydrate-last eating BEHAVIORAL

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.

Aerobic first and carbohydrate-last eating; Anaerobic first and carbohydrate-last eating

Sequential training BEHAVIORAL

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.

Aerobic first and carbohydrate-last eating; Aerobic first and usual eating; Anaerobic first and carbohydrate-last eating; Anaerobic first and usual eating

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (9)

DF Fit Anhui Wuhu

Wuhu, Anhui, 241303, China

Location

DF Fit Henan Zhengzhou

Zhengzhou, Henan, 451100, China

Location

DF Fit Liaoning Shenyang

Shenyang, Liaoning, 110326, China

Location

DF Fit Shandong Zibo

Zibo, Shandong, 256402, China

Location

DF Fit Shanghai Fengxian

Shanghai, Shanghai Municipality, 201418, China

Location

DF Fit Zhejiang Hangzhou

Hangzhou, Zhejiang, 311256, China

Location

DF Fit Zhejiang Jinhua

Jinhua, Zhejiang, 321035, China

Location

Peking University

Beijing, 100083, China

Location

DF Fit Beijing Huairou

Beijing, 101499, China

Location

MeSH Terms

Conditions

Obesity; Overweight; Insulin Resistance; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Central Study Contacts

Xingbo Li, PhD

CONTACT

8618000315430; 2616394236@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (9)