- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01186523
Long-term Exercise, Weight Loss and Energy Balance
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Kansas
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Lawrence, Kansas, Forente stater, 66045
- Energy Balance Lab, The University of Kansas
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Between group weight change at 10 months
Tidsramme: 10 months
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10 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Body Composition
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Joseph E Donnelly, EdD, University of Kansas
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HSCL15226
- R01DK049181 (U.S. NIH-stipend/kontrakt)
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