- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00775970
Walking, Spontaneous Physical Activity and Lipid Oxidation After Dietary Treatment of Obesity
October 17, 2008 updated by: University Hospital, Tours
Influence of Walking on Spontaneous Physical Activity and on Lipid Oxidation Following Dietary Treatment of Obesity
The purpose of this study is to determine whether walking exercise after dietary treatment of obesity is associated with a decrease of the daily spontaneous physical activity and\or with an increase of the time spent in sedentary activities.
Our hypothesis is that the practice of walking as an exercise during the phase of weight stability following the dietary treatment of obesity leads to a reduction of spontaneous physical activity and\or to an increase in the time spent in sedentary activities.
Study Overview
Detailed Description
The subjects of this study will be randomised in 2 groups:
A group with usual follow-up and a group with usual follow-up associated with recommendations to introduce a program of walking achieving gradually 2000-2500 kcal/week.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: David JACOBI, MD
- Phone Number: +33247474727
- Email: jacobi@med.univ-tours.fr
Study Contact Backup
- Name: Pascaline RAMEAU, CRA
- Phone Number: +33247366249
- Email: rameau@med.univ-tours.fr
Study Locations
-
-
-
Tours, France, 37044
- Recruiting
- Service de Médecine Interne - Nutrition / CHRU de Tours
-
Contact:
- David JACOBI, MD
- Phone Number: +33247472269
- Email: jacobi@med.univ-tours.fr
-
Principal Investigator:
- David JACOBI, MD
-
Sub-Investigator:
- Charles COUET, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women from 18 to 50 year-old
- In phase of weight stability
- BMI<40kg/m²
Exclusion Criteria:
- History of bariatric surgery
- Diabetes
- Suspicion of obstructive sleep apnea syndrome
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Daily time of moderate physical activity, inactivity and total physical activity measured by a portable monitor of physical activity
Time Frame: 10 weeks
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Daily energy expenditure and respiratory quotient during a stay in a respiration chamber
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David JACOBI, MD, Service de médecine Interne-Nutrition
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zurlo F, Lillioja S, Esposito-Del Puente A, Nyomba BL, Raz I, Saad MF, Swinburn BA, Knowler WC, Bogardus C, Ravussin E. Low ratio of fat to carbohydrate oxidation as predictor of weight gain: study of 24-h RQ. Am J Physiol. 1990 Nov;259(5 Pt 1):E650-7. doi: 10.1152/ajpendo.1990.259.5.E650.
- van Aggel-Leijssen DP, Saris WH, Wagenmakers AJ, Hul GB, van Baak MA. The effect of low-intensity exercise training on fat metabolism of obese women. Obes Res. 2001 Feb;9(2):86-96. doi: 10.1038/oby.2001.11.
- Levine JA, Eberhardt NL, Jensen MD. Role of nonexercise activity thermogenesis in resistance to fat gain in humans. Science. 1999 Jan 8;283(5399):212-4. doi: 10.1126/science.283.5399.212.
- Brage S, Brage N, Franks PW, Ekelund U, Wong MY, Andersen LB, Froberg K, Wareham NJ. Branched equation modeling of simultaneous accelerometry and heart rate monitoring improves estimate of directly measured physical activity energy expenditure. J Appl Physiol (1985). 2004 Jan;96(1):343-51. doi: 10.1152/japplphysiol.00703.2003. Epub 2003 Sep 12.
- Fogelholm M, Kukkonen-Harjula K. Does physical activity prevent weight gain--a systematic review. Obes Rev. 2000 Oct;1(2):95-111. doi: 10.1046/j.1467-789x.2000.00016.x.
- Froidevaux F, Schutz Y, Christin L, Jequier E. Energy expenditure in obese women before and during weight loss, after refeeding, and in the weight-relapse period. Am J Clin Nutr. 1993 Jan;57(1):35-42. doi: 10.1093/ajcn/57.1.35.
- Jequier E, Schutz Y. Long-term measurements of energy expenditure in humans using a respiration chamber. Am J Clin Nutr. 1983 Dec;38(6):989-98. doi: 10.1093/ajcn/38.6.989.
- Kraemer WJ, Volek JS, Clark KL, Gordon SE, Incledon T, Puhl SM, Triplett-McBride NT, McBride JM, Putukian M, Sebastianelli WJ. Physiological adaptations to a weight-loss dietary regimen and exercise programs in women. J Appl Physiol (1985). 1997 Jul;83(1):270-9. doi: 10.1152/jappl.1997.83.1.270.
- Levine JA, Schleusner SJ, Jensen MD. Energy expenditure of nonexercise activity. Am J Clin Nutr. 2000 Dec;72(6):1451-4. doi: 10.1093/ajcn/72.6.1451.
- Nicklas BJ, Rogus EM, Goldberg AP. Exercise blunts declines in lipolysis and fat oxidation after dietary-induced weight loss in obese older women. Am J Physiol. 1997 Jul;273(1 Pt 1):E149-55. doi: 10.1152/ajpendo.1997.273.1.E149.
- van Aggel-Leijssen DP, Saris WH, Hul GB, van Baak MA. Short-term effects of weight loss with or without low-intensity exercise training on fat metabolism in obese men. Am J Clin Nutr. 2001 Mar;73(3):523-31. doi: 10.1093/ajcn/73.3.523.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Study Registration Dates
First Submitted
October 17, 2008
First Submitted That Met QC Criteria
October 17, 2008
First Posted (Estimate)
October 20, 2008
Study Record Updates
Last Update Posted (Estimate)
October 20, 2008
Last Update Submitted That Met QC Criteria
October 17, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRI07-DJ APS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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