- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01186523
Long-term Exercise, Weight Loss and Energy Balance
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Kansas
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Lawrence, Kansas, Förenta staterna, 66045
- Energy Balance Lab, The University of Kansas
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 400 kcal of exercise/session
|
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.
Andra namn:
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Experimentell: 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.
Andra namn:
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Experimentell: Control, no exercise
No exercise control group
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Between group weight change at 10 months
Tidsram: 10 months
|
10 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Body Composition
Tidsram: 10 months
|
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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Joseph E Donnelly, EdD, University of Kansas
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HSCL15226
- R01DK049181 (U.S.S. NIH-anslag/kontrakt)
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