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

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00980863
First received: September 18, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00980863

Locations
Switzerland
Sanatorium Kilchberg
Zuerich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Waldemar Greil, Professor Sanatorium Kilchberg, Switzerland
  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
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014