Inflamation, Insulin Resistance, Obesity & Overweight
Conditions
Keywords
child and adolescent obesity, obesity & overweight, child and adolescent insulin resistance
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.
Interventions
BEHAVIORALCarbohydrate-last eating
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.
BEHAVIORALSequential training
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.
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | From enrollment to the end of treatment at 28 days | Measures the body weight change in kg |
| Body fat | From enrollment to the end of treatment at 28 days | Changes in body fat percentage |
| HOMA-IR | From enrollment to the end of treatment at 28 days | Changs in HOMA-IR, or insulin resistance, in participants |
Countries
China
Contacts
CONTACTXingbo Li, PhD
Outcome results
None listed