OverweightNCT00991549
Diabetes Prevention In Estrie
A study testing interdisciplinary intervention or meeting-seminars in people with Overweight and Glucose Intolerance, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
This study compared the efficacy at one year of an interdisciplinary approach including individual counseling and group seminars versus group seminars alone to induce weight loss in subjects at high risk of developing type 2 diabetes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Overweight, Glucose Intolerance
- What is being tested?
- interdisciplinary intervention or meeting-seminars
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2004to Jan 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pre diabetic state underlined by a marginal fasting glycemia between 6,1 and 6,9 mmol/L and/or a glucose intolerance with glucose confirmed by an OGTT 2 hours
- overweight or obesity (BMI > 27 kg/m² ; (Body Mass Index))
- enlightened assent
Who cannot join
- Impossibility to be present at the visits
- Physical/motor incapacity (or other) making one unable and/or insecure to walk at a moderate to rapid speed of 6 min and more
- Use of an anti-obesity treatment during 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
About this study
Official title: Comparative Evaluation of the Effectiveness of 2 Available Resources in Estrie, for the Prevention of Type 2 Diabetes in High-risk Subjects
This study compared the efficacy at one year of an interdisciplinary approach including individual counseling and group seminars versus group seminars alone to induce weight loss in subjects at high risk of developing type 2 diabetes.
This study also compare if a participant's presence in small informative meeting groups as the only form of intervention is sufficient to induce a lifestyle change, thus inducing the weight loss needed for the prevention of the diseases associated with obesity.
Read the detailed description
Eligible participants will be randomized into 2 intervention groups (30 per group):
- Small Meeting groups: a curriculum of 25 meeting-seminars will take place for 45 minutes, each one approaching various aspects of nutrition, physical activity, psychology, motivation and medical needs. These seminars are administered by the professionals of the obesity clinic and are already in place. However, these are usually only offered to the patients registered with the obesity clinic.
- Obesity Clinic of CHUS: combination of 25 described meeting-seminars see-high, in addition to individual interviews every 6 weeks with the interdisciplinary team of the obesity clinic of CHUS (usual operation).
Subjects will be evaluated initially and then every 3 months during 1 year by the following measurements: questionnaires to evaluate motivation and physical activity; 3 day dietary journals; weight assessment, using both metabolic and mechanical balance; waist circumference; and blood pressure.
A medical evaluation with size measure, a test evaluating knowledge of the participants on obesity, OGTT (Oral Glucose Tolerance Test) - a 5 hour determination of secretion and resistance to insulin, insulin-mediated suppression of plasma non-esterified fatty acids, a plasma lipid profile, accelerometry, bio electric impedance, and an activity physical test (6 minute walk test) will be carried out initially, and then repeated for up to 1 year.
- Conditions
- Overweight, Glucose Intolerance
- Being tested
- interdisciplinary intervention or meeting-seminars
- Keywords
- overweight, obesity, glucose intolerance, pre-diabetes
- Medical subject headings
- Overweight, Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interdisciplinary intervention or meeting-seminarsBehavioural
one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | interdisciplinary weight loss intervention Receives: Behavioral: interdisciplinary intervention or meeting-seminars |
| 2 | Active comparator | Small group seminars without interdisciplinary intervention Receives: Behavioral: interdisciplinary intervention or meeting-seminars |
What is being measured
The primary outcome is the main question the study is designed to answer.
a weight loss of 7% in at least 19% of the subjects
Measured: one year
reduced body weight of at least 5.6 kg in at least 25% of the subjects
Measured: one year
an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects
Measured: one year
a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects
Measured: one year
a reduced percentage of the calories introduced in the form of fat of at least 6.6%, in absolute value, in at least 25% of the subjects
Measured: one year
Secondary outcomes (5)
change in insulin sensitivity by HOMA
Measured: one year
change in insulin secretion during an OGTT by deconvolution of plasma c-peptide
Measured: one year
change in beta cell function by calculation of the disposition index
Measured: one year
change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT
Measured: one year
relation between weight loss and change in insulin sensitivity, beta cell function, and insulin-mediated suppression of plasma non-esterified fatty acids
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startDec 2004
- Primary completionOct 2007
- Study completionJan 2008
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 OverweightStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Ministere de la Sante et des Services Sociaux, Novonordisk endocrine fellowship program
- Investigators
- Marie-France Langlois, MD, Principal investigator, Medecine department, Division of endocrinology, CHUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991549
- Sponsor's protocol ID
- 04-087
- Status last verified
- Oct 2009
- First submitted
- 7 Oct 2009
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Gagnon C, Brown C, Couture C, Kamga-Ngande CN, Hivert MF, Baillargeon JP, Carpentier AC, Langlois MF. A cost-effective moderate-intensity interdisciplinary weight-management programme for individuals with prediabetes. Diabetes Metab. 2011 Nov;37(5):410-8. doi: 10.1016/j.diabet.2011.01.003. Epub 2011 Apr 13.
PubMed 21489843
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Effectiveness of 2 Available Resources in Estrie, for the Prevention of Type 2 Diabetes in High-risk Subjects
- ClinicalTrials.gov ID
- NCT00991549
- Acronym / sponsor ID
- 04-087
- Conditions
- Overweight, Glucose Intolerance
- Keywords
- overweight, obesity, glucose intolerance, pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Ministere de la Sante et des Services Sociaux, Novonordisk endocrine fellowship program
- Study start
- Dec 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 8 Oct 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 compared the efficacy at one year of an interdisciplinary approach including individual counseling and group seminars versus group seminars alone to induce weight loss in subjects at high risk of developing type 2 diabetes.
This study also compare if a participant's presence in small informative meeting groups as the only form of intervention is sufficient to induce a lifestyle change, thus inducing the weight loss needed for the prevention of the diseases associated with obesity.
Detailed description
Eligible participants will be randomized into 2 intervention groups (30 per group):
- Small Meeting groups: a curriculum of 25 meeting-seminars will take place for 45 minutes, each one approaching various aspects of nutrition, physical activity, psychology, motivation and medical needs. These seminars are administered by the professionals of the obesity clinic and are already in place. However, these are usually only offered to the patients registered with the obesity clinic.
- Obesity Clinic of CHUS: combination of 25 described meeting-seminars see-high, in addition to individual interviews every 6 weeks with the interdisciplinary team of the obesity clinic of CHUS (usual operation).
Subjects will be evaluated initially and then every 3 months during 1 year by the following measurements: questionnaires to evaluate motivation and physical activity; 3 day dietary journals; weight assessment, using both metabolic and mechanical balance; waist circumference; and blood pressure.
A medical evaluation with size measure, a test evaluating knowledge of the participants on obesity, OGTT (Oral Glucose Tolerance Test) - a 5 hour determination of secretion and resistance to insulin, insulin-mediated suppression of plasma non-esterified fatty acids, a plasma lipid profile, accelerometry, bio electric impedance, and an activity physical test (6 minute walk test) will be carried out initially, and then repeated for up to 1 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: interdisciplinary intervention or meeting-seminarsinterdisciplinary weight loss intervention |
| 2 | Active comparator | Behavioral: interdisciplinary intervention or meeting-seminarsSmall group seminars without interdisciplinary intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- pre diabetic state underlined by a marginal fasting glycemia between 6,1 and 6,9 mmol/L and/or a glucose intolerance with glucose confirmed by an OGTT 2 hours
- overweight or obesity (BMI > 27 kg/m² ; (Body Mass Index))
- enlightened assent
Key exclusion criteria (6 listed)
- Impossibility to be present at the visits
- Physical/motor incapacity (or other) making one unable and/or insecure to walk at a moderate to rapid speed of 6 min and more
- Use of an anti-obesity treatment during the last 3 months
- Bariatric Surgery in the past
- Planned Pregnancy
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 or meeting-seminarsone-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle | Behavioural | 1, 2 |
Primary outcome
a weight loss of 7% in at least 19% of the subjects
Time frame: one year
reduced body weight of at least 5.6 kg in at least 25% of the subjects
Time frame: one year
an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects
Time frame: one year
a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects
Time frame: one year
a reduced percentage of the calories introduced in the form of fat of at least 6.6%, in absolute value, in at least 25% of the subjects
Time frame: one year
5 secondary outcomes
change in insulin sensitivity by HOMA
Time frame: one year
change in insulin secretion during an OGTT by deconvolution of plasma c-peptide
Time frame: one year
change in beta cell function by calculation of the disposition index
Time frame: one year
change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT
Time frame: one year
relation between weight loss and change in insulin sensitivity, beta cell function, and insulin-mediated suppression of plasma non-esterified fatty acids
Time frame: one year
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 8 Oct 2009.
- Derived from this study: PubMed 21489843Gagnon C, Brown C, Couture C, Kamga-Ngande CN, Hivert MF, Baillargeon JP, Carpentier AC, Langlois MF. A cost-effective moderate-intensity interdisciplinary weight-management programme for individuals with prediabetes. Diabetes Metab. 2011 Nov;37(5):410-8. doi: 10.1016/j.diabet.2011.01.003. Epub 2011 Apr 13.
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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 or meeting-seminars in people with Overweight and Glucose Intolerance, 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?
The sponsor lists 3 inclusion and 6 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 8 Oct 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?
a weight loss of 7% in at least 19% of the subjects (time frame: one year). The study lists 5 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 NCT00991549, 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 8 Oct 2009.