Bipolar DisorderNCT00980863
Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder
A study testing lifestyle intervention to increase physical activity in people with Bipolar Disorder, run by University of Zurich at 1 site in Switzerland.
Trial summary
Patients with bipolar disorder are at increased risk of weight gain, which in turn, increases the risk for somatic disease and non-adherence to maintenance therapy. Therefore, interventions addressing weight gain are expedient for the management of this disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- lifestyle intervention to increase physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2005to Aug 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 18 and 70 years of age were considered for inclusion if they:
- fulfilled the diagnostic criteria for bipolar disorder according to DSM-IV-TR,27;
- were on treatment with medication for at least three months with one of the following substances: lithium, valproic acid carbamazepine, oxcarbazepine, olanzapine, quetiapine, risperidone, amisulpride; and
- were not underweight (BMI > 20 kg/m2).
Who cannot join
- Pregnancy
- Actual breast feeding
- A diagnosis of anorexia nervosa or bulimia nervosa
- Diabetes type I or II or another serious physical disease
- Use of substances that reduce weight (e.g., topiramate, lamotrigine as mood stabilizer in monotherapy)
- Participants with comorbidity of acute psychosis, drug addiction, personality disorder, suicidal tendencies or a current severe manic or depressive episode were excluded only if attending the program was not possible due to the respective disorder
Trial locations and contacts
1 site in 1 country.
About this study
Patients with bipolar disorder are at increased risk of weight gain, which in turn, increases the risk for somatic disease and non-adherence to maintenance therapy. Therefore, interventions addressing weight gain are expedient for the management of this disorder. The investigators set out to evaluate the effects of a lifestyle intervention on body mass index, cardiovascular, glycemic and metabolic parameters in patients with bipolar disorder under mood stabilizing pharmacological treatment. 50 outpatients with bipolar disorder under mood stabilizing treatment participated in a randomized controlled trial (waiting control group N=24 and multimodal lifestyle intervention N=26). Each experimental group consisted of two cohorts. The intervention lasted five months and consisted of eleven group sessions and weekly fitness training. Body Mass Index (BMI), body weight as well as cardiovascular, glycemic and metabolic parameters were determined as baseline (March and September 2005) and after five (July 2005 and January 2006) and eleven months (January and July 2006).
- Conditions
- Bipolar Disorder
- Being tested
- lifestyle intervention to increase physical activity
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle intervention to increase physical activityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention to increase physical activity | Active comparator | Not described Receives: Behavioral: lifestyle intervention to increase physical activity |
| waiting control group | No intervention | Not described Receives: Behavioral: lifestyle intervention to increase physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startMar 2005
- Primary completionAug 2006
- Study completionAug 2006
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 Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Waldemar Greil, Professor, Principal investigator, Sanatorium Kilchberg, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980863
- Sponsor's protocol ID
- LQ-bip
- Status last verified
- Sep 2009
- First submitted
- 18 Sep 2009
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Gillhoff K, Gaab J, Emini L, Maroni C, Tholuck J, Greil W. Effects of a multimodal lifestyle intervention on body mass index in patients with bipolar disorder: a randomized controlled trial. Prim Care Companion J Clin Psychiatry. 2010;12(5):PCC.09m00906. doi: 10.4088/PCC.09m00906yel.
PubMed 21274359
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00980863
- Acronym / sponsor ID
- LQ-bip
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 21 Sep 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.
Patients with bipolar disorder are at increased risk of weight gain, which in turn, increases the risk for somatic disease and non-adherence to maintenance therapy. Therefore, interventions addressing weight gain are expedient for the management of this disorder. The investigators set out to evaluate the effects of a lifestyle intervention on body mass index, cardiovascular, glycemic and metabolic parameters in patients with bipolar disorder under mood stabilizing pharmacological treatment. 50 outpatients with bipolar disorder under mood stabilizing treatment participated in a randomized controlled trial (waiting control group N=24 and multimodal lifestyle intervention N=26). Each experimental group consisted of two cohorts. The intervention lasted five months and consisted of eleven group sessions and weekly fitness training. Body Mass Index (BMI), body weight as well as cardiovascular, glycemic and metabolic parameters were determined as baseline (March and September 2005) and after five (July 2005 and January 2006) and eleven months (January and July 2006).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention to increase physical activity | Active comparator | Behavioral: lifestyle intervention to increase physical activity |
| waiting control group | No intervention | Behavioral: lifestyle intervention to increase physical activity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults between 18 and 70 years of age were considered for inclusion if they:
Key exclusion criteria (6 listed)
- Pregnancy
- Actual breast feeding
- A diagnosis of anorexia nervosa or bulimia nervosa
- Diabetes type I or II or another serious physical disease
- Use of substances that reduce weight (e.g., topiramate, lamotrigine as mood stabilizer in monotherapy)
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 intervention to increase physical activity | Behavioural | Lifestyle intervention to increase physical activity, waiting control group |
Primary outcome
BMI
Time frame: 11 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 21 Sep 2009.
- Derived from this study: PubMed 21274359Gillhoff K, Gaab J, Emini L, Maroni C, Tholuck J, Greil W. Effects of a multimodal lifestyle intervention on body mass index in patients with bipolar disorder: a randomized controlled trial. Prim Care Companion J Clin Psychiatry. 2010;12(5):PCC.09m00906. doi: 10.4088/PCC.09m00906yel.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
Waldemar Greil, Professor principal investigator
Sanatorium Kilchberg, Switzerland
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 to increase physical activity in people with Bipolar Disorder, run by University of Zurich at 1 site in Switzerland.
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 4 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 21 Sep 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 Switzerland. 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?
BMI (time frame: 11 months). 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 NCT00980863, 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 21 Sep 2009.