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

NCT ID: NCT00980863

Last Updated: 2009-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-08-31

Brief 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).

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle intervention to increase physical activity

Group Type: ACTIVE_COMPARATOR

lifestyle intervention to increase physical activity

Intervention Type: BEHAVIORAL

waiting control group

Group Type: NO_INTERVENTION

lifestyle intervention to increase physical activity

Intervention Type: BEHAVIORAL

Interventions

lifestyle intervention to increase physical activity

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Privatklinik Sanatorium Kilchberg

Principal Investigators

Waldemar Greil, Professor

Role: PRINCIPAL_INVESTIGATOR

Sanatorium Kilchberg, Switzerland

Locations

Sanatorium Kilchberg

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 21274359 (View on PubMed)

Other Identifiers

LQ-bip

Identifier Type: -

Identifier Source: org_study_id