Long-term Exercise, Weight Loss and Energy Balance
調査の概要
詳細な説明
Exercise is recommended by virtually every public health organization; however, the role of exercise is generally considered secondary to energy restriction for the treatment of obesity. Indeed, an argument can be made that suggests exercise is not effective for weight loss. Meta-analytic studies consistently find small amounts of weight loss due to exercise without energy restriction. It is critical to note that there are actually very few randomized controlled trials using exercise alone for weight loss. We believe that there are 3 critical flaws in the vast majority of the literature. 1)Participants are not supervised and is generally recorded by self report and is likely poorly estimated and in general, overestimated. 2)The amount of exercise used is usually prescribed from the guidelines for recommended levels for physical fitness and to diminish cardiovascular disease, not the amount that may be necessary for weight loss. 3)The energy expenditure of the exercise is rarely reported.
Participants will be randomly assigned to expend either 400 or 600kcal per exercise session (or a control group) and will exercise 5 days per week for 9 months. All exercise sessions will be supervised and the length of the exercise session will be based upon energy expenditure (kcal/min) at a give heart rate range. To account for improvements in fitness, energy expenditure will be measured monthly and adjustments to the daily exercise prescription will be altered accordingly.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Kansas
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Lawrence、Kansas、アメリカ、66045
- Energy Balance Lab, The University of Kansas
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 18 years or greater
- males & females
- <500kcal exercise/wk
- BMI 25-40
Exclusion Criteria:
- known cardiovascular and metabolic disorders,
- weight altering product use
- smoking
- clinical depression
- special diets
研究計画
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:防止
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:400 kcal of exercise/session
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To see if there is a variance in weight loss and energy balance between men and women with similar energy expenditure over an extended period of time.
他の名前:
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実験的:600 Kcal of exercise/session
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To see if there is a variance in weight loss and energy balance between men and women with similar energy expenditure over an extended period of time.
他の名前:
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実験的:Control, no exercise
No exercise control group
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To see if there is a variance in weight loss and energy balance between men and women with similar energy expenditure over an extended period of time.
他の名前:
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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 |
時間枠 |
|---|---|
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Between group weight change at 10 months
時間枠:10 months
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10 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Body Composition
時間枠:10 months
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Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by DEXA.
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10 months
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Resting Metabolic Rate
時間枠:10 months
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Resting metabolic rate will be determined via indirect calorimetry following an overnight fast.
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10 months
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Total Daily Energy Expenditure
時間枠:10 months
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Total daily energy expenditure will be determined using the doubly labeled water procedure
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10 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Joseph E Donnelly, EdD、University of Kansas
出版物と役立つリンク
一般刊行物
- Herrmann SD, Willis EA, Honas JJ, Lee J, Washburn RA, Donnelly JE. Energy intake, nonexercise physical activity, and weight loss in responders and nonresponders: The Midwest Exercise Trial 2. Obesity (Silver Spring). 2015 Aug;23(8):1539-49. doi: 10.1002/oby.21073.
- Ptomey LT, Willis EA, Honas JJ, Mayo MS, Washburn RA, Herrmann SD, Sullivan DK, Donnelly JE. Validity of energy intake estimated by digital photography plus recall in overweight and obese young adults. J Acad Nutr Diet. 2015 Sep;115(9):1392-9. doi: 10.1016/j.jand.2015.05.006. Epub 2015 Jun 26.
- Donnelly JE, Honas JJ, Smith BK, Mayo MS, Gibson CA, Sullivan DK, Lee J, Herrmann SD, Lambourne K, Washburn RA. Aerobic exercise alone results in clinically significant weight loss for men and women: midwest exercise trial 2. Obesity (Silver Spring). 2013 Mar;21(3):E219-28. doi: 10.1002/oby.20145.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。