Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder

Study Overview
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Brief Summary
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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).

Official Title
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Effects of a Lifestyle Intervention on Body Mass Index in Patients With Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Behavioral: lifestyle intervention to increase physical activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle intervention to increase physical activity<br> | Behavioral: lifestyle intervention to increase physical activity<br> <br> |
| No Intervention: waiting control group<br> | Behavioral: lifestyle intervention to increase physical activity<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | 11 months |