Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Bipolar Disorder |
Behavioral: lifestyle intervention to increase physical activity |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder |
- BMI [ Time Frame: 11 months ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | March 2005 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Lifestyle intervention to increase physical activity | Behavioral: lifestyle intervention to increase physical activity |
| No Intervention: waiting control group | Behavioral: lifestyle intervention to increase physical activity |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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).
Exclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Waldemar Greil, Privatklinik Sanatorium Kilchberg |
| ClinicalTrials.gov Identifier: | NCT00980863 History of Changes |
| Other Study ID Numbers: | LQ-bip |
| Study First Received: | September 18, 2009 |
| Last Updated: | September 18, 2009 |
| Health Authority: | Switzerland: Ethikkommission |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013