ObesityNCT00775970
Walking, Spontaneous Physical Activity and Lipid Oxidation After Dietary Treatment of Obesity
A study testing walking activity in people with Obesity, run by University Hospital, Tours at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- walking activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women from 18 to 50 year-old
- In phase of weight stability
- BMI<40kg/m²
Who cannot join
- History of bariatric surgery
- Diabetes
- Suspicion of obstructive sleep apnea syndrome
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Interne - Nutrition / CHRU de Tours
Tours, 37044
David JACOBI, MD, +33247472269, jacobi@med.univ-tours.fr
David JACOBI, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- walking activity
- Keywords
- Obesity, Weight loss maintenance, Spontaneous physical activity, Lipid oxydation, Walking
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking activityBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily time of moderate physical activity, inactivity and total physical activity measured by a portable monitor of physical activity
Measured: 10 weeks
Secondary outcomes (1)
Daily energy expenditure and respiratory quotient during a stay in a respiration chamber
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Investigators
- David JACOBI, MD, Principal investigator, Service de médecine Interne-Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775970
- Sponsor's protocol ID
- PHRI07-DJ APS
- Status last verified
- Oct 2008
- First submitted
- 17 Oct 2008
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12972441Fogelholm 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.
PubMed 12119991Froidevaux 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.
PubMed 8416662Jequier 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.
PubMed 6650455Kraemer 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.
PubMed 9216973Levine 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.
PubMed 9880251Levine 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.
PubMed 11101470Nicklas 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.
PubMed 9252491van 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.
PubMed 11237927van 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.
PubMed 11316351Zurlo 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.
PubMed 2240203
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Walking on Spontaneous Physical Activity and on Lipid Oxidation Following Dietary Treatment of Obesity
- ClinicalTrials.gov ID
- NCT00775970
- Acronym / sponsor ID
- PHRI07-DJ APS
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss maintenance, Spontaneous physical activity, Lipid oxydation, Walking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- May 2008
- First posted
- 20 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women from 18 to 50 year-old
- In phase of weight stability
- BMI<40kg/m²
Key exclusion criteria (3 listed)
- History of bariatric surgery
- Diabetes
- Suspicion of obstructive sleep apnea syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking activity | Behavioural | – |
Primary outcome
Daily time of moderate physical activity, inactivity and total physical activity measured by a portable monitor of physical activity
Time frame: 10 weeks
1 secondary outcome
Daily energy expenditure and respiratory quotient during a stay in a respiration chamber
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2008.
- Background: PubMed 12972441Brage 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.
- Background: PubMed 12119991Fogelholm 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.
- Background: PubMed 8416662Froidevaux 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.
- Background: PubMed 6650455Jequier 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.
- Background: PubMed 9216973Kraemer 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.
- Background: PubMed 9880251Levine 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.
- Background: PubMed 11101470Levine 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.
- Background: PubMed 9252491Nicklas 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.
- Background: PubMed 11237927van 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.
- Background: PubMed 11316351van 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.
- Background: PubMed 2240203Zurlo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David JACOBI, MD principal investigator
Service de médecine Interne-Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking activity in people with Obesity, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David JACOBI, MD (+33247474727, jacobi@med.univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily time of moderate physical activity, inactivity and total physical activity measured by a portable monitor of physical activity (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00775970, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2008.