- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01186523
Long-term Exercise, Weight Loss and Energy Balance
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Kansas
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Lawrence, Kansas, États-Unis, 66045
- Energy Balance Lab, The University of Kansas
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Expérimental: 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.
Autres noms:
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Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Between group weight change at 10 months
Délai: 10 months
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10 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Body Composition
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Joseph E Donnelly, EdD, University of Kansas
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HSCL15226
- R01DK049181 (Subvention/contrat des NIH des États-Unis)
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