ObesityNCT00664495
Reduction of Abdominal Obesity and Insulin Resistance in Women
A study testing Diet Weight Loss, Exercise Weight Loss and Exercise Without Weight Loss in people with Obesity, run by Queen's University at 1 site in Canada.
Trial summary
The purpose of the study was to assess the effects of equivalent diet- or exercise-induced weight loss and related insulin resistance in abdominally obese women. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Diet Weight Loss, Exercise Weight Loss and Exercise Without Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Apr 1999to Dec 2003
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women
Who cannot join
- Smokers and diabetics
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study was to assess the effects of equivalent diet- or exercise-induced weight loss and related insulin resistance in abdominally obese women.
- Conditions
- Obesity
- Being tested
- Diet Weight Loss, Exercise Weight Loss, Exercise Without Weight Loss
- Keywords
- Obesity, exercise, diet, insulin resistance
- Medical subject headings
- Obesity, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet Weight LossBehavioural
Exercise Weight LossBehavioural
Exercise Without Weight LossBehavioural
| Study group | Role | What they receive |
|---|---|---|
| C | No intervention | Control |
| DWL | Active comparator | Diet Weight Loss Receives: Behavioral: Diet Weight Loss |
| EWL | Active comparator | Exercise Weight Loss Receives: Behavioral: Exercise Weight Loss |
| EWS | Active comparator | Exercise Without Weight Loss Receives: Behavioral: Exercise Without Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Obesity
Measured: 4 months
Insulin Resistance
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startApr 1999
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Robert Ross, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664495
- Sponsor's protocol ID
- Ross 1999
- Status last verified
- Apr 2008
- First submitted
- 21 Apr 2008
- Last updated
- 23 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Ross R, Janssen I, Dawson J, Kungl AM, Kuk JL, Wong SL, Nguyen-Duy TB, Lee S, Kilpatrick K, Hudson R. Exercise-induced reduction in obesity and insulin resistance in women: a randomized controlled trial. Obes Res. 2004 May;12(5):789-98. doi: 10.1038/oby.2004.95.
PubMed 15166299
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Abdominal Obesity and Insulin Resistance in Women
- ClinicalTrials.gov ID
- NCT00664495
- Acronym / sponsor ID
- Ross 1999
- Conditions
- Obesity
- Keywords
- Obesity, exercise, diet, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 1999
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 23 Apr 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 the study was to assess the effects of equivalent diet- or exercise-induced weight loss and related insulin resistance in abdominally obese women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| C | No intervention | –Control |
| DWL | Active comparator | Behavioral: Diet Weight LossDiet Weight Loss |
| EWL | Active comparator | Behavioral: Exercise Weight LossExercise Weight Loss |
| EWS | Active comparator | Behavioral: Exercise Without Weight LossExercise Without Weight Loss |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Premenopausal women
Key exclusion criteria (1 listed)
- Smokers and diabetics
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 |
|---|---|---|
| Diet Weight Loss | Behavioural | DWL |
| Exercise Weight Loss | Behavioural | EWL |
| Exercise Without Weight Loss | Behavioural | EWS |
Primary outcome
Abdominal Obesity
Time frame: 4 months
Insulin Resistance
Time frame: 4 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2008.
- Results publication: PubMed 15166299Ross R, Janssen I, Dawson J, Kungl AM, Kuk JL, Wong SL, Nguyen-Duy TB, Lee S, Kilpatrick K, Hudson R. Exercise-induced reduction in obesity and insulin resistance in women: a randomized controlled trial. Obes Res. 2004 May;12(5):789-98. doi: 10.1038/oby.2004.95.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Robert Ross, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Weight Loss, Exercise Weight Loss and Exercise Without Weight Loss in people with Obesity, run by Queen's University at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Apr 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Obesity (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT00664495, which also lists 1 linked publication.
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 23 Apr 2008.