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

2026年7月13日 更新者:Peking University
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.

調査の概要

研究の種類

介入

入学 (推定)

480

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Beijing、中国、100083
        • Peking University
        • コンタクト:
      • Beijing、中国、101499
        • DF Fit Beijing Huairou
        • コンタクト:
    • Anhui
      • Wuhu、Anhui、中国、241303
        • DF Fit Anhui Wuhu
        • コンタクト:
    • Henan
      • Zhengzhou、Henan、中国、451100
        • DF Fit Henan Zhengzhou
        • コンタクト:
    • Liaoning
      • Shenyang、Liaoning、中国、110326
        • DF Fit Liaoning Shenyang
        • コンタクト:
    • Shandong
      • Zibo、Shandong、中国、256402
        • DF Fit Shandong Zibo
        • コンタクト:
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、201418
        • DF Fit Shanghai Fengxian
        • コンタクト:
    • Zhejiang
      • Hangzhou、Zhejiang、中国、311256
        • DF Fit Zhejiang Hangzhou
        • コンタクト:
      • Jinhua、Zhejiang、中国、321035
        • DF Fit Zhejiang Jinhua
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:階乗代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
実験的: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.
実験的: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Weight
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2026年8月31日

研究の完了 (推定)

2026年9月30日

試験登録日

最初に提出

2026年7月13日

QC基準を満たした最初の提出物

2026年7月13日

最初の投稿 (実際)

2026年7月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月17日

QC基準を満たした最後の更新が送信されました

2026年7月13日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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