- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01186523
Long-term Exercise, Weight Loss and Energy Balance
Studieoversigt
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Kansas
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Lawrence, Kansas, Forenede Stater, 66045
- Energy Balance Lab, The University of Kansas
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
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Eksperimentel: 600 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.
Andre navne:
|
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Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Between group weight change at 10 months
Tidsramme: 10 months
|
10 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Body Composition
Tidsramme: 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
Tidsramme: 10 months
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joseph E Donnelly, EdD, University of Kansas
Publikationer og nyttige links
Generelle 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HSCL15226
- R01DK049181 (U.S. NIH-bevilling/kontrakt)
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