ObesityNCT01008878
Treatment of the Metabolic Syndrome in an Interdisciplinary Obesity Clinic: a Randomized Controlled Study
A study testing interdisciplinary intervention in people with Obesity and Metabolic Syndrome, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
This study is a randomized, controlled and opened trial designed to compare the effects of an interdisciplinary moderate-intensity lifestyle modification program vs. conventional treatment by primary care physicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- interdisciplinary intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2004to Jun 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Criteria Inclusion:
- referred to the obesity clinic by a medical doctor;
- BMI > 27 kg/m²; (Body Mass Index)
- metabolic associated syndrome according to the definition of the NCEP-ATP III
- be able to give an inform consent
Criteria Exclusion:
- Impossibility to be present at the visits
- Physical/motor incapacity (or other) making one unable and insecure to walk at a moderate to rapid speed for 6 min and more
- Use of an anti-obesity treatment the last 3 months
- Bariatric Surgery in the past
- Planned Pregnancy
- Pacemaker
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
This study is a randomized, controlled and opened trial designed to compare the effects of an interdisciplinary moderate-intensity lifestyle modification program vs. conventional treatment by primary care physicians.
We want to show the benefits of coherent interdisciplinary care in the obesity clinic of CHUS (Centre Hospitalier Universitaire de Sherbrooke) in comparison to the conventional treatment in order to:
- Improve subjects' characteristic features of metabolic syndrome: weight, waist circumference, fatty mass, plasma lipid profile, blood pressure, fasting glycaemia, and HbA1c;
- Improve our patients' nutritive practices;
- Decrease our patients' sedentary lifestyle;
- Improve our patients' motivation to lose weight, and to improve their quality of life; We also wish to define predictors of answer in order to better select the patients if necessary, and evaluate the costs incurred by the health system.
Read the detailed description
Eligible participants recruited from patients, referred through the obesity clinic were separated into two groups.
The interdisciplinary treatment group received interventions at our clinic for 6 months.. The intervention included a visit every 6 weeks including a nursing consultation (listening, psychological support, anthropometric measurements and blood pressure), an endocrinologist consultation, a nutritionist consultation (initial evaluation of food intake and counselling), a psychologist consultation if needed, an interactive group information session (to discuss the following: diet, psychological aspects associated with obesity, physical education, complications and pharmacological treatments of obesity), and a questionnaire on the individual costs of their visit.
A control group was monitored during this 6 months by their family physician, as per usual.
A biological assessment, questionnaires, and tests will be carried out in beginning and end of program: the questionnaires are to evaluate the physical activity (Sallis, Canada fitness survey); the quality of life (IWQOL-Lite, SF-36); the motivation (analogical visual Scales); knowledge (pretest and post-test); and costs. Tests to assess physical activity (6-minute walk test and accelerometer) will also be administered.
After the first 6 months, both groups were followed at the obesity clinic for another 12 months.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- interdisciplinary intervention
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interdisciplinary interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
After 6 months of follow-up, the treatment group proportion achieved a 5% reduction in body weight compared to the control group.
Measured: 6 months
Secondary outcomes (2)
Weight; fatty mass; features of the metabolic syndrome; food intake; energy expenditure; quality of life; motivation; cost/effectiveness.
Metabolic syndrome characteristics
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startMar 2004
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Investigators
- Marie-France Langlois, MD, Principal investigator, Medecine Department, Division of endocrinology, CHUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008878
- Sponsor's protocol ID
- 04-003
- Status last verified
- Nov 2009
- First submitted
- 5 Nov 2009
- Last updated
- 6 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of the Metabolic Syndrome in an Interdisciplinary Obesity Clinic: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01008878
- Acronym / sponsor ID
- 04-003
- Conditions
- Obesity, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 6 Nov 2009 (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.
This study is a randomized, controlled and opened trial designed to compare the effects of an interdisciplinary moderate-intensity lifestyle modification program vs. conventional treatment by primary care physicians.
We want to show the benefits of coherent interdisciplinary care in the obesity clinic of CHUS (Centre Hospitalier Universitaire de Sherbrooke) in comparison to the conventional treatment in order to:
- Improve subjects' characteristic features of metabolic syndrome: weight, waist circumference, fatty mass, plasma lipid profile, blood pressure, fasting glycaemia, and HbA1c;
- Improve our patients' nutritive practices;
- Decrease our patients' sedentary lifestyle;
- Improve our patients' motivation to lose weight, and to improve their quality of life; We also wish to define predictors of answer in order to better select the patients if necessary, and evaluate the costs incurred by the health system.
Detailed description
Eligible participants recruited from patients, referred through the obesity clinic were separated into two groups.
The interdisciplinary treatment group received interventions at our clinic for 6 months.. The intervention included a visit every 6 weeks including a nursing consultation (listening, psychological support, anthropometric measurements and blood pressure), an endocrinologist consultation, a nutritionist consultation (initial evaluation of food intake and counselling), a psychologist consultation if needed, an interactive group information session (to discuss the following: diet, psychological aspects associated with obesity, physical education, complications and pharmacological treatments of obesity), and a questionnaire on the individual costs of their visit.
A control group was monitored during this 6 months by their family physician, as per usual.
A biological assessment, questionnaires, and tests will be carried out in beginning and end of program: the questionnaires are to evaluate the physical activity (Sallis, Canada fitness survey); the quality of life (IWQOL-Lite, SF-36); the motivation (analogical visual Scales); knowledge (pretest and post-test); and costs. Tests to assess physical activity (6-minute walk test and accelerometer) will also be administered.
After the first 6 months, both groups were followed at the obesity clinic for another 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| interdisciplinary intervention | Behavioural | – |
Primary outcome
After 6 months of follow-up, the treatment group proportion achieved a 5% reduction in body weight compared to the control group.
Time frame: 6 months
2 secondary outcomes
Weight; fatty mass; features of the metabolic syndrome; food intake; energy expenditure; quality of life; motivation; cost/effectiveness.
Metabolic syndrome characteristics
Time frame: 18 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 6 Nov 2009.
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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.
Marie-France Langlois, MD principal investigator
Medecine Department, Division of endocrinology, CHUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interdisciplinary intervention in people with Obesity and Metabolic Syndrome, run by Université de Sherbrooke 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?
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 6 Nov 2009. 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?
After 6 months of follow-up, the treatment group proportion achieved a 5% reduction in body weight compared to the control group. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2009.