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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980863
• Other study ID #: LQ-bip
• Status: Completed
• Phase: N/A
• First received: September 18, 2009
• Last updated: September 18, 2009
• Start date: March 2005
• Est. completion date: August 2006

Study information

• Verified date: September 2009
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults between 18 and 70 years of age were considered for inclusion if they:

1. fulfilled the diagnostic criteria for bipolar disorder according to DSM-IV-TR,27;

2. 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

3. 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• lifestyle intervention to increase physical activity

Locations

Country	Name	City	State
Switzerland	Sanatorium Kilchberg	Zuerich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI		11 months	No