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

Обзор

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.

Вмешательства

• Поведенческое Carbohydrate-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.
• Поведенческое Sequential 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.

Первичные конечные точки

• Weight [Срок оценки: From enrollment to the end of treatment at 28 days]
• Body fat [Срок оценки: From enrollment to the end of treatment at 28 days]
• HOMA-IR [Срок оценки: From enrollment to the end of treatment at 28 days]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 9 центров

• DF Fit Anhui Wuhu — Wuhu
• DF Fit Henan Zhengzhou — Чжэнчжоу
• DF Fit Liaoning Shenyang — Шэньян
• DF Fit Shandong Zibo — Zibo
• DF Fit Shanghai Fengxian — Шанхай
• DF Fit Zhejiang Hangzhou — Ханчжоу
• DF Fit Zhejiang Jinhua — Jinhua
• Peking University — Пекин
• … и ещё 1 центр

Идентификаторы

NCT: NCT07712068 · 2026131DFQ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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