Type 2 Diabetes MellitusHealthy_LIFENCT01828931
Lifestyle Intervention for Diabetes and Weight Management in Psychosis
A study testing Lifestyle Intervention in people with Type 2 Diabetes Mellitus and Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The rate of type-2 diabetes mellitus (T2DM) is at least 2-3 times higher in persons with psychotic illnesses than in the general population. Life expectancy of individuals with psychosis is also 20-25 years less than the general population, primarily due to premature onset of cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Nov 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 70 years (inclusive)
- DSM-IV-TR diagnosis of one of the psychotic disorders listed above
- Body Mass Index (BMI) > 25 kg/m2 at the time of enrollment
- Clearly documented diagnosis of type-2 diabetes mellitus or prediabetes
- Ability to provide informed consent
- No medical contraindication to participation in weight reduction / exercise program, determined in consultation with their primary care physician
- Female participants, of childbearing potential, using a medically accepted means of contraception
Who cannot join
- Inability to give informed consent
- Currently enrolled in a formal structured weight management program
- Currently being prescribed medication specifically for weight loss
- Participants with unstable or active cardiovascular illnesses (myocardial infarction, CHF, etc), active or end-stage renal disease, unstable thyroid disease, etc.
- Recurrent episodes of diabetic ketoacidosis, seizure or coma without warning or severe hypoglycemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Intensive Lifestyle Interventions in the Management of Diabetes in Individuals With Psychosis
The rate of type-2 diabetes mellitus (T2DM) is at least 2-3 times higher in persons with psychotic illnesses than in the general population. Life expectancy of individuals with psychosis is also 20-25 years less than the general population, primarily due to premature onset of cardiovascular disease (CVD). Despite the high risk for T2DM and CVD, psychotic illness has been an exclusion criterion in all large-scale studies of diabetes prevention and management. We propose a 3-year randomized controlled trial examining the effectiveness of a lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity in overweight or obese individuals (N=150) suffering from both a psychotic illness and T2DM. Weight and glycemic control will be the primary outcome variables. It is hypothesized that a significant weight reduction and improvement in glycemic control will be found in those who receive the LI relative to those who do not.
- Conditions
- Type 2 Diabetes Mellitus, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Bipolar I Disorder, Substance-induced Psychosis
- Being tested
- Lifestyle Intervention, Usual Care
- Medical subject headings
- Diabetes Mellitus, Type 2, Schizophrenia, Psychotic Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity
Usual CareOther
Care as usual
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Standard care provided via participants' family physicians, diabetes nurses, and psychiatrists. Receives: Other: Usual Care |
| Lifestyle Intervention | Experimental | A lifestyle intervention based on the Look AHEAD study intervention, involving counselling related to dietary and physical activity habits. Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 52 weeks
HbA1c levels
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Diabetes Association
- Responsible party
- Principal investigator, Margaret Hahn, Centre for Addiction and Mental Health
- Investigators
- Margaret K Hahn, M.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828931
- Sponsor's protocol ID
- 151/2012
- Acronym
- Healthy_LIFE
- Status last verified
- Jun 2016
- First submitted
- 9 Apr 2013
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intensive Lifestyle Interventions in the Management of Diabetes in Individuals With Psychosis
- ClinicalTrials.gov ID
- NCT01828931
- Acronym / sponsor ID
- Healthy_LIFE / 151/2012
- Conditions
- Type 2 Diabetes Mellitus, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Bipolar I Disorder, Substance-induced Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Diabetes Association
- Study start
- Dec 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Apr 2013 (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 rate of type-2 diabetes mellitus (T2DM) is at least 2-3 times higher in persons with psychotic illnesses than in the general population. Life expectancy of individuals with psychosis is also 20-25 years less than the general population, primarily due to premature onset of cardiovascular disease (CVD). Despite the high risk for T2DM and CVD, psychotic illness has been an exclusion criterion in all large-scale studies of diabetes prevention and management. We propose a 3-year randomized controlled trial examining the effectiveness of a lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity in overweight or obese individuals (N=150) suffering from both a psychotic illness and T2DM. Weight and glycemic control will be the primary outcome variables. It is hypothesized that a significant weight reduction and improvement in glycemic control will be found in those who receive the LI relative to those who do not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareStandard care provided via participants' family physicians, diabetes nurses, and psychiatrists. |
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionA lifestyle intervention based on the Look AHEAD study intervention, involving counselling related to dietary and physical activity habits. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between the ages of 18 and 70 years (inclusive)
- DSM-IV-TR diagnosis of one of the psychotic disorders listed above
- Body Mass Index (BMI) > 25 kg/m2 at the time of enrollment
- Clearly documented diagnosis of type-2 diabetes mellitus or prediabetes
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Inability to give informed consent
- Currently enrolled in a formal structured weight management program
- Currently being prescribed medication specifically for weight loss
- Participants with unstable or active cardiovascular illnesses (myocardial infarction, CHF, etc), active or end-stage renal disease, unstable thyroid disease, etc.
- Recurrent episodes of diabetic ketoacidosis, seizure or coma without warning or severe hypoglycemia
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 |
|---|---|---|
| Lifestyle InterventionA lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity | Behavioural | Lifestyle Intervention |
| Usual CareCare as usual | Other | Usual Care |
Primary outcome
Weight
Time frame: 52 weeks
HbA1c levels
Time frame: 52 weeks
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 17 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Margaret K Hahn, M.D. principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Type 2 Diabetes Mellitus and Schizophrenia, run by Centre for Addiction and Mental Health 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 7 inclusion and 5 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 17 Jun 2016. 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?
Weight (time frame: 52 weeks). 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?
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 17 Jun 2016.